MANAGER of MEDICAL COMMUNICATION and MSL TEAM for IMMUNOLOGY for Immunology to $120 plus bonus and car, Montreal or Toronto

Preferred candidates are bilingual sales/marketing professionals with some CHE experience in Montreal or Toronto including a background in Immunology or other specialty care area. You will head up a team of medical communication / MSL specialists across Canada. Requirements for this position:

· 5 years experience leading a team of pharmaceutical sales people, marketing or MSL’s

· Hiring, training, coaching and creating a viable working group to perform optimally

· Experience partnering internally with clinical research, marketing, MSL’s, business intelligence

· Experience developing and implementing a Communication plan for KOL’s in the territories with appropriate budget plans, performance analysis and evaluation

· Reacting quickly to the possibility of missing performance targets by taking corrective action

· Manage budgets, analyze and report variances within prescribed quarterly time frames

· Represent the company to all external customers including prescribers, patient advocacy groups, payers and governments and developing long-term credible relationships

· Experience evaluating and reporting to superiors about competitive products and market trends

· Ability to adjust plans and integrate new information into the regional strategy

· A robust and engaging leadership style with excellent communication and negotiation skills

· Solid understanding of market dynamics in specialty care and Immunology. Seeks answers from legal staff and compliance associates to clarify ambiguities and terminology

To apply, send CV in Word format to: hbotkin@sympatico.ca and/or call Herb at 416 225-8071.

MEDICAL COMMUNICATION / LIAISON MANAGER for IMMUNOLOGY MANAGER for Immunology to $115 K plus bonus and car, Ontario, NFLD, NS

In this field-based position for parts of Ontario, Newfoundland and Nova Scotia, you will develop and implement the strategic and tactical plans for educational and communications activities for health care professionals and stakeholders including sales people, product managers, patient advocacy groups, etc. You have experience reviewing the scientific data and published clinical reports in Immunology and translating these into relevant information that will serve as the basis for the medical communication plan. At the same time you will have the experience and ability to influence Key Opinion Leaders and gain their support for market access initiatives that will result in Product Listing Agreements and third party payer support.

You have experience in budgeting, leading advisory boards, developing speaker engagement opportunities, leading cross-functional teams, giving input to marketing for brand medical communication issues, securing CME approval and being proactive in getting a handle on advances in adult and medical education so as to incorporate new concepts. Also, you will have knowledge of PAAB and Regulatory requirements, forecasting metrics, competitive research including business intelligence and market access issues as well as successes in strategic physician-lead symposia.

We are searching for an experienced CME manager preferably combined with experience as a regional medical liaison / MSL and one or more of the following educational credentials: MSc. in Pharmacy or Pharmacology, MD, Ph.D., or Pharm.D. Pharmaceutical Sales / Marketing experience and an MBA would be an asset since we require a solid understanding of the Commercialization and Business aspects of the pharmaceutical industry.

To apply, send CV in Word format to: hbotkin@sympatico.ca and/or call Herb at 416 225-8071.

We are currently helping to build an Analytical development team at one of our good Pharma client sites in the Southern USA. We are looking for experienced scientists of varying levels. You must be able to develop and validate Analytical methods for Abbreviated New Drug Applications (ANDA’s).

Experience working at the bench within a Pharmaceutical development environment is ideal. You must be very well versed in HPLC, GC and dissolution apparatus to evaluate drug product candidates for extended release Oral solid dosage products.

Requirements include; minimum of a Bachelor’s degree plus 3-5 years of experience developing and validating Analytical methods.

We are currently seeking a Principal Scientist to oversee all technical aspects of the commercial process development for modified release solid dosage forms. The ideal candidate has understanding and working knowledge of commercial manufacturing equipment; fluid bed coaters, pan coaters, blenders, tablet presses, high shear granulators and more. As Principle you will develop and take ownership of the Process/Method development aspect of the ANDA filing. Your background in modified release solid dosage form offers general Formulation development understanding and Expert level Process development capabilities which may include expertise in; polymer science, raw material properties and characterization, statistical analysis and Quality by Design. This role is responsible for the process development of new products and troubleshooting of analytical non-conformances associated with existing products. We need someone who can identify and implement appropriate technologies to advance coating science capabilities like; in-house characterization and measurement of extended release film coatings, spraying application technology/methodology, industrial coating expertise in the areas of fluid bed Wurster coating and pan coating to leverage current coating knowledge, trends and technology.

The Principal Scientist; designs experimental plans for process development and design space, scale-up and optimization for new or transferred products. Generates, reviews, and analyzes analytical and statistical data to support the process development work, writes protocols and batch records to carry out process development and evaluation work, scale up and bio batch manufacturing (as required) for Abbreviated New Drug Applications (ANDAs) submission to the FDA. Plans appropriate analytical testing and stability studies, analyzes data to ascertain if it meets related protocol acceptance criteria: writes deviation reports and technical assessments as required, prepares final reports for process development, technology transfer, batch size changes, optimization, and validation studies and ensures they are approved through proper channels, maintains appropriate documentation of protocols, reports, and laboratory notebooks as required by Standard Operating Procedures, carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Ensures compliance with current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), all Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) regulations and guidelines.

Qualifications include; Degrees in a Pharmaceutical related Science; PhD with 13 years Industry experience, a Master’s Degree with 15 years experience, a Bachelor’s degree with 17 years of experience.

SENIOR SCIENTIST, PHARMA TECHNICAL OPERATIONS to $110K plus 20% Bonus, South USA

We are currently seeking a Senior Scientist to oversee all technical aspects of the commercial process development for modified release solid dosage forms. The ideal candidate has understanding and working knowledge of commercial manufacturing equipment; fluid bed coaters, pan coaters, blenders, tablet presses, high shear granulators and more. As Sr. Scientist you will develop and take ownership of the Process/Method development aspect of the ANDA filing. Your background in modified release solid dosage form offers general Formulation development understanding and Expert level Process development capabilities which may include expertise in; polymer science, raw material properties and characterization, statistical analysis and Quality by Design. The Sr. Scientist will be responsible for the process development of new products and troubleshooting of analytical non-conformances associated with existing products. We need someone who can identify and implement appropriate technologies to advance coating science capabilities like; in-house characterization and measurement of extended release film coatings, spraying application technology/methodology, industrial coating expertise in the areas of fluid bed Wurster coating and pan coating to leverage current coating knowledge, trends and technology.

The Senior Scientist; designs experimental plans for process development and design space, scale-up and optimization for new or transferred products. Generates, reviews, and analyzes analytical and statistical data to support the process development work, writes protocols and batch records to carry out process development and evaluation work, scale up and bio batch manufacturing (as required) for Abbreviated New Drug Applications (ANDAs) submission to the FDA. Plans appropriate analytical testing and stability studies, analyzes data to ascertain if it meets related protocol acceptance criteria: writes deviation reports and technical assessments as required, prepares final reports for process development, technology transfer, batch size changes, optimization, and validation studies and ensures they are approved through proper channels, maintains appropriate documentation of protocols, reports, and laboratory notebooks as required by Standard Operating Procedures, carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Ensures compliance with current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), all Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) regulations and guidelines.

Qualifications include; Degrees in a Pharmaceutical related Science; PhD with 11 years Industry experience, a Master’s Degree with 13 years experience, a Bachelor’s degree with 15 years of experience.

MEDICAL LIAISONS for PHARMACEUTICAL and BIOPHARMA COMPANIES to $110K plus car, Vancouver, Calgary and Montreal

We are currently seeking Medical Liaisons in Calgary, Vancouver and Montreal for Immunology.

You will provide scientific information to Key Opinion Leaders and medical doctors who act as principal investigators in Phase 3 and 4 clinical drug trials. You will also provide assistance to the Medical Affairs department and work closely with the Continuing Medical Education staff as well as advisory boards. Additional responsibilities include the ongoing review of scientific literature and developing business cases to support Investigator initiated drug trials. You will also work with disease state groups to educate and involve them in your patient focused campaigns.

As a Medical Liaison you will work to identify, develop and manage emerging untapped scientific opportunities for some blockbuster products in Immunology. As well, you will effectively interface with internal Scientific Research and Therapeutic teams to ensure optimal implementation of regional initiatives.

Part of this role effectively interfaces with market access and strategic partnerships to provide regional implementation support that enables resolution of market access and funding issues based on scientific data. As an advocate, the Medical Liaison will build and maintain advanced disease, product and therapy knowledge while meeting with Key Specialists to discuss studies, research science and innovative development. You will represent scientific leadership among internal and external customers.

You must have a University degree at the doctorate level or above in biological sciences, pharmacology, or pharmacy or be a PhD or MD or a Pharmacist (that is, a Pharm.D. or licensed pharmacist) with a background in Immunology preferably.

Experience working in a pharmaceutical or biotech company as an MSL or in specialty hospital sales or as a Medical Advisor or senior clinical researcher is an asset.

Willingness to travel: up to 40% is required. Positions in Montreal require functional bilingual skills.

If you have a background in this field and three or more years of experience in a customer facing role in the pharmaceutical, health care or biotech industries, then submit your CV to: hbotkin@sympatico.ca and call Herb Botkin at 416 225-8071.

DIRECTOR, LABORATORY OPERATIONS, $170K plus $80K bonus, South USA

We’re currently seeking a Director of Laboratory Operations for a pharmaceutical manufacturing facility in the southern USA. The incumbent plans, manages and directs the activities of lab operations groups for products related to routine production, stability, complaints, to site transfer products, alternate vendor approval, validation protocols and methods validation by performing duties personally or through subordinate staff support.

The Director provides managerial support, direction and coaching while maintaining departmental employee recruitment, selection, training, development and safety, promotion and retention levels to ensure proper and effective staffing. This position is responsible for over 100 direct and indirect staff members and works closely with the Site Head of Quality.

You must have oversight of at least 50-80 personnel in order to be considered for this position. We are looking for a dynamic leader who understands how to drive Lab production through Motivation, Operational and Process excellence resulting in maximum output and results.

As Director, you will direct the Analytical testing groups to assure product and components comply with specifications while reviewing, evaluating and modifying test methods and procedures as needed including OOS Investigations. The Director reviews and prepares annual budgets for assigned areas of responsibility in the Lab Operations department. As the Group leader you will be reviewing and approving SOP’s and other lab documentation while directing the Training and Reviewing group to assure that all documentation is complete and accurate and that new employees are properly trained.

You must have a Bachelor’s Degree in Chemistry, Pharmaceutical Science or a related field with a minimum of 8 years in progressive management positions within the pharmaceutical industry. You should have good experience influencing upper management and all subordinate levels with your compatible yet adaptable leadership style. A background in GMP’s and Operational Excellence/Lean/Six Sigma and experience with HPLC, GC and LIMS is required.

CLINICAL DATA MANAGER, to $70K plus bonus, Toronto

Our client, in the Pharmaceutical/Biotechnology sector, is currently searching for a Clinical Data Manager to join a winning team of like minded professionals working in all phases of drug development and in multiple therapeutic categories.

Bring at least four years of hands on experience in clinical trial data management with knowledge of clinical trial electronic data capture systems and processes along with knowledge of clinical drug development processes and FDA regulatory requirements, as well as ICH/GCP guidelines and we will get you an interview right away.

Within project deadlines, you must effectively lead projects in clinical trial data management and integrate them concurrently with the entire clinical trial. As a proven CDM, you must be able to manage project timelines and coordinate activities for projects that are assigned to you. All of your past experience developing data management Plans and Clinical trial case report forms, makes you an ideal candidate for this newly created post. Lastly, you will be required to perform database quality control procedures as required.

MSc. in health sciences, physical or biological sciences with post-grad work in clinical research studies

Must have proven industry experience from a Pharma, Biotech or Medical device company.

Please call Cris Murray 416 225-6386 to find out more information about this exciting new opportunity. Email your CV in Word format to jedgar@sympatico.ca

CLINICAL DATA MANAGEMENT DIRECTOR to $120K plus bonus, Toronto

As the leader of the CDM department you will be responsible for the implementation, control and maintenance of all clinical databases to ensure Regulatory compliance with International standards. With a number of clinical drug trials in process currently, we require solid experience in budgeting and staffing to ensure an efficient and effective distribution of resources is achieved. Your expertise in clinical data capture tools and databases has been fined tuned by your experience in designing functional input forms and formats, managing and storing the data in accessible modes and being able to assure all users of its’ integrity. Above all you will be required to comply with the operational needs of related departments such as biostatistics / programming, Quality Assurance, Audit, medical writing, etc.

The medical and clinical liaisons you will be working with from a number of different therapeutic categories representing drugs in phases 2-4, require someone with excellent communications skills; someone who is approachable, informative and business-minded; someone who is up-to-date on the latest data management techniques and protocols. Since you will be part of a team that bids on getting new drug trials assigned by global partners to the Canadian operation, your ability to evaluate and implement slant edge data capture systems is crucial.

Above all, as a Director you will be assessed by your ability to create a viable working group; training, motivating and developing your staff, ranging from 10-25 in total. Therefore, previous managerial experience with direct reports is a must along with effective superior communication skills.

Call Cris Murray at 416 225-6386. Email your CV in Word format to jedgar@sympatico.ca

REGULATORY AFFAIRS ASSOCIATE/ Project Manager - $70K – Toronto.

We are currently seeking a Regulatory Affairs Associate/Project Manager for a leading Pharmaceutical firm located in Toronto. This is a one year contract opportunity.

As a Regulatory Affairs Associate you are responsible for; Preparing and/or reviewing submissions for solid oral dosage forms and liquid dosage forms to Health Canada (i.e. NDS, ANDS, S/ANDS, CTA, NC, Annual Report, and Cross-Licenses) and/or Provincial Formularies, preparing and/or reviewing responses to deficiency letters (Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes), coordinate the servicing of Notices of Allegations for patents, Review Product Monographs, Package Inserts and Label text, Coordinate French translations of Product Monographs and Package Inserts, assist in negotiations with Health Canada to ensure a prompt regulatory approval, liaise with groups internally and externally to collect documents and information, coordinate laboratory analysis as necessary, Review Change Controls and determine filing requirements, Provide regulatory support to internal/external customers, Maintain current awareness regulatory guidelines (Health Canada, ICH, EMEA, FDA, etc.) and other duties as required by the Director or Manager.

You must have; a University Degree, B.Sc. or higher in Chemistry or Health Sciences, 3-5 years of relevant experience in Canadian Regulatory Affairs, Provincial Formulary experience is an asset, Strong working knowledge of regulatory guidelines, Excellent organizational and communication skills (oral and written), the Ability to prioritize many projects and work with deadlines, Computer Literacy – Microsoft Package including Word, Excel, and Outlook; WordPerfect; Adobe Acrobat; Access Database.

We are looking for a good problem solver with the ability to prepare written responses to deficiency letters from regulatory agencies as this aspect of the work requires the most attention to detail, as well as obtaining approval of changes to approved drug products.

TEAM LEADER ANALYTICAL R+D, $90 to $100K plus Bonus, Southern USA

We are currently seeking an experienced Group Leader to manage a small team of Analytical Scientists at one of our good client locations in the Southern US. We are looking for someone with Generics experience, particularly experienced with ANDA submissions and solid oral dosage controlled release forms in a cGMP, cGLP, ICH and FDA regulated production environment.

The incumbent will be responsible for reviewing and approving methods, specifications and reports while analyzing and solving complex problems. You must be able to design and execute entire development projects. We’re looking for someone who has experience preparing analytical documents from early stage product development to ANDA submission. We need someone who has responded successfully to FDA deficiency letters. You should be expert in Stability testing, investigation and data review.

You must have a Master’s Degree or Ph.D. in Pharmaceutical Technology or a related field plus 8-10 years of pharmaceutical industry experience. We need someone who can; Troubleshoot analytical methods and laboratory instrumentation, work with Chromatography Data Acquisition systems like Empower or Chemstation, communicate clearly and effectively, lead a team using sound knowledge of Pharmaceutical analysis and hands-on technical skills, and most of all – someone who can mentor other Scientists.

PHARMA SCIENTIST, TECHNICAL SERVICES, to $85K plus bonus, South USA

We are currently building a team of Pharmaceutical Technical Services Scientists to carry out laboratory work to support somewhat complex method investigations, method validations, method transfers, and method comparisons. Under the direction of senior colleagues, Technical Services Scientists will perform non-routine testing, such as evaluation of USP proposals/revisions and reference standard qualifications.

Technical Services Scientists will complete standard and sample preparation using general laboratory equipment such as; pH meter, balance, IR spectrometer, UV/VIS spectrometer, HPLC and dissolution apparatus as well as more advanced analyses, which require a higher level of technical skill and knowledge like AA spectrometry and GC. Managing wet chemistry tests as needed, which may include TLC, LOD, titration, particle size, disintegration, hardness, and friability are also within the mandate. Other responsibilities include; performing qualitative and quantitative analyses in support of complex method investigations and method validations following approved protocols, interpreting analyses findings, identifying/reporting on how technique outcomes at various stages of the analytical process impact the results. As TS Scientist you will be conducting non-routine testing such as evaluation of USP proposals/revisions, routine cleaning validation testing and reference standard qualification as well as performing qualitative and quantitative analyses in support of method transfers and method comparisons following established procedures and approved protocols.

More TS Scientist duties include: writing protocols and reports to support method investigations/method validations, performing data calculations with PC applications and specialized lab (instrument) applications, performing basic troubleshooting of instruments/equipment, carrying out cGMP and technical training, as it pertains to the area of work, meeting project deadlines and performance standards as assigned. As TS Scientist you may be asked to develop, write and review new procedures, test methods and specifications documents as well as updating existing procedures, test methods and specifications documents while ensuring compliance with all Company policies and procedures, including safety rules and regulations.

You must have experience with; cGMP, FDA, regulatory rules, Pharma Lab SOP’s, UV/IR, AA and GC instruments operation methods and techniques, spectroscopic and chromatographic operation, techniques and Systems, current computer applications, safety rules and regulations, working in cohesive team structures to maximize productivity.

You should have a Bachelor’s Science degree – in Chemistry or a related science, plus 2-4 years experience (minimum) working in a cGMP, FDA regulated Pharmaceutical R+D and Production Environment. Post graduate degrees, certifications or more years of experience are all assets, please include all of your details in your resume.

QUALITY ASSURANCE MANAGER, $90 to $100K, Toronto

We are currently seeking a QA Manager to oversee the operational aspects of a Pharmaceutical manufacturer’s Quality Assurance department in strict accordance with all Standard Operating Procedures, current Good Manufacturing Practices, company policies and procedures, and Regulatory requirements governing the manufacture and importing of Pharmaceutical products.

The QA Manager is responsible for; Overseeing and performing the release of product to the marketplace, carrying out managerial responsibilities in accordance with the organization’s policies, procedures, and federal, provincial and local laws while overseeing, managing coordinating and prioritizing the daily activities of the Quality Assurance Department and assigned staff. The QA Manager reviews and approves production and process control Standard Operating Procedures (SOPs) that are drafted, reviewed and approved by other organizational units, ensures department compliance with and enforcement of SOPs and current Good Manufacturing Practices (cGMPs). Managing Quality systems that support compliant plant operations and managing the identification, investigation, and closeout of all manufacturing deviations while managing QA batch records and record archiving is part of the mandate.

As QA Manager, you will coordinate with Manufacturing and Packaging management to ensure compliance with and understanding of cGMPs, Company policies and practices, and safety procedures. The QA Manager is instrumental in reviewing and finalizing the completion of inspections and audits to ensure compliance with cGMP’s, SOP’s, company practices and government regulations. You will be responsible for preparing reports for the Director of Quality Systems and executive management while overseeing, participating and approving the interviewing, hiring, and training of departmental employees. As a leader and a Mentor, you will provide support, direction and coaching to subordinate employees in the areas of training, problem resolution, and planning including ensuring project deadlines and performance standards are established and met.

The ideal candidate has expertise with; the principles of Quality Assurance management, leadership and training, pharmaceutical principles - practices and their application, Health Canada, FDA, SOP, cGMP and all pertinent regulatory compliance and requirements, recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.

You must have a Bachelor’s Degree in Pharmacy, Life Sciences or a related field from an accredited college or University plus 5-7 years of professional level experience including 3 years in a supervisor or managerial capacity or an equivalent combination of education and experience.

Salary range: $90 to $100K, Location: Toronto

QUALITY CONTROL MANAGER, PHARMACEUTICALS, $90 to 95K, Toronto

We are currently seeking a QC Manager for one of our good Pharma client sites in Toronto. In this role, the QC Manager; manages, plans and directs the activities and testing of finished products, in process materials and stability samples while strategically managing the day to day operations of the QC lab with a strong focus on process and quality improvements.

The main duties of the post include: the coordination of third party testing by contract laboratories and method transfers into the QC laboratory, ensuring all analytical functions performed by analysts are in full compliance with GMP, maintaining a continuous state of audit readiness and act as co- host for laboratory audits conducted by internal or external individuals/groups, management (planning and execution) of analytical activities in support of marketed product including testing of raw materials, packaging components, in-process materials, drug products, and finished products, scheduling and coordinating third party analytical testing of components and commercial products to ensure availability as required, providing analytical support for process and cleaning validation, sampling / testing support (chemical / microbiological) for the Environmental Monitoring Program, ensure calibration, qualification / certification and preventative maintenance programs are adequate for analytical instrumentation as it applies to commercial products, ensure, in collaboration with the Method Development Group, that analytical test methods are appropriately transferred to the QC Lab for routine testing of commercial products, manage the OOS / LIR program including investigation strategies, root cause determination, conclusions/recommendations and final approval.

As QC Manager you should have experience with: the approval of SOP’s and change controls generated as they apply to Quality Control functions, reviewing laboratory documentation to ensure detailed, accurate and complete, LIMS, evaluating and providing on-going training based on Analyst performance, providing analytical trend data to Quality Assurance for incorporation into Annual Product Quality Reviews and Vendor Certification programs, providing support to Quality Assurance in the qualification / certification of Contract Analytical Laboratories, operational and capital budgeting for the laboratory.

You should have a B.Sc. in Chemistry or a related science plus 5 years as Supervisor or QC Manager in a cGMP regulated Pharma environment.

We are currently looking for experienced Quality Control/QC Chemists to join a successful

R+D group in the southern USA. This pharmaceutical company has achieved amazing growth

in the past 18 months and is now ready for new experts at the bench. You must have at least 5 years of experience in a safe cGMP, FDA – DEA compliant QC lab adhering to established SOP’s in the Pharmaceutical industry.

We’re looking for Chemist’s with expertise in; HPLC, GC, UV, Automatic titrator, IR, AA and TLC. Experience performing more complex chemistry including wet chemistry tests on intermediate and finished products (LOD, pH, titration) using both standard and sample solutions as required by test methods is important. You should have strong experience conducting; calibration, qualification and maintenance of laboratory instrumentation; pH meter, dissolution equipment and HPLC. You should be well versed in laboratory Applications also; E, HPLC, FTIR, AA.

Aside from the Technical aspects of this role, we’re looking for individuals who comply with good housekeeping and safety practices, who participate in troubleshooting of analytical test methods and lab instruments and who are happy to train and assist other team members to benefit the success of the whole team.

Qualifications include; Bachelor of Science degree or higher plus at least 5 years experience

Testing products at all levels of development and production. You must have excellent communication skills in English and strong Mathematical skills including Statistics as documentation management is a key responsibility of a QC Chemist.

Call Jason Edgar at 416 225-2628 or Cris Murray at 416 225-6386 for all the details.

We are currently seeking an Analytical Development Manager to lead a group of Scientists in a FDA regulated GMP Pharmaceutical R+D and Manufacturing environment. This position directs and participates in formulation studies to assess new product feasibility and calls for strong experience in physical testing of APIs, excipients and finished products using FTIR, HPLC, UV-Vis Spec.

The Manager of Analytical Development will interact with other departments to disseminate strategy and provide details for defined studies while providing accurate, timely, and quality performance of all formulation activities needed for product submission, approval and launch. As a contributing member of the Team you will help define and implement strategy for product development while collaborating with Quality Control, Microbiology, Validation, Compounding, and Regulatory Affairs to coordinate pilot and commercial batches, conduct analytical method development, validation, method transfer, and stability studies for raw materials and finished drug products. You will design and characterize new formulations, and ensure that they can be transferred into existing drug products manufacturing site for scale-up. Your team will perform feasibility studies, method development, and method validation for various analytical instruments (e.g. HPLC, UV, and Particle Sizer) as well as generate monographs, specifications, compounding records, and various technical protocols/reports including CMC sections for FDA submissions of drug products.

You should have a minimum of a Bachelor’s or a Master’s Degree in Biology, Chemistry or Pharmaceutical Sciences plus 6-8 years of Analytical/Formulation development for Solid Oral Dosage pharmaceuticals or nutraceuticals. Any generics experience is a bonus. Good experience contributing to CMC sections for regulatory filings as well as understanding how the FDA handles PAI’s is an asset. You should have strong experience with Stability programs and Validation protocols. Working with suppliers and outside CMO experience will help in this role. Leading, Supervising or Managing a team of Scientists is required for this post.

DIRECTOR, ANALYTICAL DEVELOPMENT, to $220K plus bonus, South USA

We are currently seeking a Director of Analytical Development for a pharmaceutical manufacturing facility in the southern USA. The incumbent plans, manages and directs the activities of an Analytical chemistry group of about 30 Scientists and Engineers. As Director, you will lead Principle Scientists and their teams and 2 Associates Directors and direct this multidisciplinary team that provides support for product and process development, as well as manufacturing and quality control. This position reports to the VP of Research and Development.

Develop and Validate analytical testing methods for new products or modify/enhance the existing test methodologies, Validate and evaluate analytical test methods and support system improvements and process refinement, write technical reports and prepare data for presentation and review, create SOP’s; test procedures, change controls and reports while effectively communicate status, progress and challenges internally and externally in written and verbal formats, Troubleshoot results and perform root cause analysis, investigate laboratory out of specification (OOS) test results and document findings, identify quality or safety issues and provide support in their resolution. The Analytical Development group supports process validation, stability, and method transfer activities to QC and contract manufacturers. The Analytical Development group will interface with registrations, supply chain and manufacturers of intermediates, final technical products and formulators as well as overseeing certification of new raw material sources and suppliers. Oversight of; Inventory, trouble shooting and calibrating analytical instrumentation as well as providing analytical standards for active ingredients and corresponding impurities are all activities performed by the Analytical Development group.

We are looking for a dynamic leader who has the technical expertise to lead a high level group of this nature. You must be able to deem respect from a group of highly skilled Scientists and Engineers while directing Analytical process development activities in a high growth Solid Oral Dosage R+D and Production environment. Your leadership style is fair and decisive, you have had success with the FDA (audits, pre-approval inspections etc…) and you have had successful interfacing with executive stakeholders. You must have a minimum of a MSc., plus 10 years experience in Pharmaceuticals working in R+D, Lab Operations, Analytical development or Formulations. Logical and suitable combinations of Academics and Pharmaceutical experiences will all be considered.

Salary: $180-220K. Bonus: 35%. Relocation: Thorough and Generous. Location: Southern USA.

SENIOR MANAGER for HEALTH ECONOMICS and OUTCOMES in the PHARMACEUTICAL INDUSTRY, to $120K, Montreal

We are currently seeking an individual for a senior managerial role in Health Economics / Health Outcomes / Pricing / Market Access. Your experience will include pharmaco-economic modeling and analysis and the design and implementation of health economics and drug reimbursement strategies for internal and external stakeholders. You will work in a collaborative role with the team in Pricing and Drug Plan Affairs.

In this senior role you will head up a team to develop public and private market strategies for key products. You will identify critical outcomes research needs in order to optimize market access. As well, this position participates in advisory boards, symposia and other regional/national professional meetings where relevant clinical and outcomes research are presented and discussed. You should have a fairly good understanding of the PMPRB and the Common Drug Review Committee.

You must have a University degree in health economics (preferably at the Master’s or Ph.D. level) and a basic life science degree together with practical understanding of economic modeling as it applies to evaluating the cost effectiveness and cost utility of various drug therapies. This experience coupled with 7 - 10 years of business or life sciences experience working with the Pharmaceutical or Biotech industries or in the health care sector with any of the various public health agencies or in academia would be an asset. Knowledge of modeling programs, SAS, understanding of product listing agreements, clinical drug trials, health outcomes, market access issues are all assets.

Above all our client wants someone who can lead and work in a team environment and someone who is flexible.

Salary is $120K -$130K plus bonus of 15% -20% and a gas card. This is a permanent full-time position requiring that you are functionally bilingual.

Call Herb Botkin at 416 225-8071 to discuss and please send your CV in Word format to hbotkin@sympatico.ca

MANAGER of REIMBURSEMENT, POLICY and MARKET ACCESS, to $120K plus bonus plus car, Montreal

We are currently seeking a Reimbursement/ Policy / Market Access Manager with experience in the development and implementation of drug reimbursement strategies for public and private sector payers and external stakeholders including patient advocacy groups. You will work in a collaborative role with the head of the Market Access team to ensure third party payer relations are coordinated and focused on a broad group of leading edge therapies.

You will be instrumental in developing and sustaining relationships with key figures in the insurance and drug benefits management industries and with influential public service contacts who are involved in the decision making process on a number of private insurance company drug plans and federally sponsored drug programs for the purpose of attaining drug formulary listings. You will use both your updated product knowledge on an array of drug therapies and your familiarity with the reimbursement process to ensure optimal opportunity for advancing the interests of the company while garnering support from disease state stakeholder groups.

You are a master at negotiations and you have a strong knowledge of private and public sector drug formulary procedures, drug pricing and the contacts that ensure formulary listings. Alternatively your background may include experience in sales, marketing or business development.

You should have a University degree in business or life sciences with 3-5 years experience in the Pharmaceutical industry or health care sector, preferably with a public or private payer or with a pharmaceutical or insurance benefits industry association. It would be an asset to have experience in product management, sales, market access or health economic and outcomes management. English is acceptable for the Toronto and Ottawa positions but Bilingualism is preferred for the Quebec based position.

Call Herb Botkin at 416 225-8071 for all the details. Email your CV in Word format to: hbotkin@sympatico.ca.

DIRECTOR of MARKET ACCESS for PHARMACEUTICAL INDUSTRY, to $150 plus 25% bonus, Montreal

Because the Canadian Health care system has a limit on the amount it can spend to cover the costs of drugs and medical devices for people covered under public and private health plans, we require a skilled person to evaluate both existing and new health care products in light of such financial constraints. You have experience developing policy recommendations to governments and private insurance companies that will see them provide coverage for existing and new products. You should have a background in developing reliable estimates of the efficacy and costs of drugs/medical devices and you should have an appreciation of the legal or ethical issues surrounding new products. As well you should have experience engaging the medical community to support your policy recommendations to governments and private health plan payers. Above all you must be influential in your relationships with MP’s to achieve the goal of securing Product Listing Agreements.

You will be responsible for developing and leading a “state of the art” health technology evaluation centre that creates senior-level relationships with the Canadian Agency for Drugs and Technologies in Health and with the National Institute for Excellence in Health and Social Services. In this centre, you will develop the tools that go into producing quality submissions to garner favourable reimbursement decisions utilizing domestic and foreign trends in technology evaluation.

Above all you have an excellent appreciation of the various drug pricing issues in Canada and the Regulatory environment that affects prices. You will be responsible for establishing and maintaining links with the Canadian and international groups within your company that are engaged in Public Affairs and Health Technology Evaluation.

Significant experience in the health care industry combined with managerial experience and advanced degrees in one or more of: Medicine, Pharmacy, Business, Health Economics are required for this bilingual position in Montreal.

Call Herb Botkin at 416 225-8071 for all the details. Email your CV in Word format to: hbotkin@sympatico.ca.

MEDICAL LIAISONS for PHARMACEUTICAL and BIOPHARMA COMPANIES, to $120K plus bonus and car, Vancouver, Calgary, Toronto and Montreal

We are currently seeking Medical Liaisons in Calgary, Vancouver, Toronto and Montreal for Oncology or Respirology or Vaccines or HIV/Virology. If you have a background in any of these therapeutic areas or in related areas such as Immunology and you have a minimum of a Master’s degree and at least 2-3 years experience in a customer facing role in the pharmaceutical or biotech industries.

As a Medical Liaison you will work to identify, develop and manage emerging untapped scientific opportunities for some blockbuster products in Vaccines, Oncology, Respirology or HIV. As well, you will effectively interface with internal Scientific Research and Therapeutic teams to ensure optimal implementation of regional initiatives.

You must have a University degree at the Master’s level or above in biological sciences, pharmacology, or pharmacy or be a PhD or MD or a Pharmacist (that is, a Pharm.D. or licensed pharmacist) with a background in Respirology or Oncology or Vaccines or HIV preferably.

Experience working in a pharmaceutical or biotech company as an MSL or in specialty hospital sales or as a Medical Advisor or senior clinical researcher is an asset.

Call Herb Botkin at 416 225-8071 for all the details. Email your CV in Word format to: hbotkin@sympatico.ca.

SENIOR MANUFACTURING ENGINEER to $125K plus bonus Florida

We are currently seeking a Sr. Manufacturing Engineer in Pharmaceuticals to; troubleshoot equipment and processes in the manufacturing and packaging areas, interface with QA and R+D on process requirements for new and current products, develop plans for implementation of new product line and new equipment, work in conjunction with the Maintenance Department to identify recurrent problems, research new equipment and process improvements, and recommend and implement equipment upgrades and the purchase of new equipment that better meets regulatory requirements.

Other responsibilities include; researching and making recommendations to Managers regarding on-site transfer projects and product scale-up activities, and improvements in manufacturing and control systems. The incumbent may be called upon to design and maintain monitoring and reporting systems for yields, capacity downtime, cycle-time, efficiencies, labor utilization and plan compliance. This position may assist area management in performing investigations and preparing capital expenditure requests in training all employees in new equipment, systems and processes.

You must have a Bachelors Degree in Engineering and at least 5-10 years of process engineering experience in the pharmaceutical industry. CGMP, FDA experience in a regulated pharmaceutical manufacturing environment (OSHA, FDA, EPA, AQMD).

Assets include: Lean/Six Sigma or PMP certification, experience leading Lean/Six Sigma initiatives for processes in Dry and wet blend granulation, fluid bed granulates, high shear granulators, blenders, mills, multiple tablet presses and tablet coaters (sugar coating) and packaging equipment systems such as slat fillers and cappers.

Call Jason Edgar at 416 225-2628 for more details and email resume in Word format to careers@jedgarcareers.com

We are currently looking for an Associate Director for Facilities/Utilities and Plant maintenance. Reporting to the Director of Operations, the Associate Director, Engineering Operations will plan, direct and oversee the work activities of the Facilities Maintenance and Equipment Maintenance Departments and assures that Company and Government compliance standards are adhered to by all.

These departments provide timely and efficient flow of scheduled services; provide timely engineering support to manufacturing, packaging, and laboratories administration and in addition, provide repair and preventive maintenance for all facility buildings and support equipment. This position will develop organization structure, departmental budgets and long range plans.

The ideal candidate has knowledge and experience working in regulated environments, preferably the pharmaceutical industry. Experience in the design, operation and maintenance of plant equipment and manufacturing process and/or facilities utility support such as electrical, HVAC and water systems is required.

You should also have proven skills in; Microsoft Office, handling multiple projects and tasks, and strong written, oral and presentation skills. Strong leadership experience and abilities is also required. A PMP designation is a valuable asset.

A University degree in Engineering, plus any Engineering based certifications; Lean Six Sigma, Project Management, Professional Engineer status etc…are assets.

PRINCIPAL SCIENTIST, FORMULATIONS DEVELOPMENT, to $120K, plus 20% bonus Southern USA

We are currently seeking Formulations Scientists to carry out design and development of solid oral dosage forms from ANDA filing through product launch. The role centers around developing and executing formulation strategies related to product development, e.g. project planning and timelines, experimental design, data evaluation, formulation of relevant and scientifically based conclusions, coordinating studies with other technical groups (Analytical Sciences, Legal, and Regulatory & Pharma Tech). This position maintains a high level of expertise within the field and develops new technologies and concepts to be applied in the development of oral controlled release drug products. The incumbent identifies, analyzes and suggests corrective actions to optimize R&D processes, technology and regulatory compliance issues.

Responsibilities include: Design of experimental plan and perform pre-formulation, formulation development work on Oral Controlled release and immediate release dosage forms, generates and reviews analytical data to support the product development work, writes protocols and batch records to carry out process development and evaluation work, scale up and pivotal batch manufacturing for Abbreviated New Drug Applications (ANDA’s) submission to regulatory agency including appropriate analytical testing and stability studies on pivotal batches, performs appropriate documentation and prepares pharmaceutical product development report (PDR), Quality overall Summary (QOS) and other necessary documents to support regulatory filing of ANDA’s, planning bioequivalence studies on drug product and evaluating the bioequivalence data to recommend changes in formulation- if needed, carrying out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Ensures compliance with current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), all Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) regulations and guidelines.

Other responsibilities involve acting as a Team Lead of Junior Scientists who will work towards the development and technology transfer of solid oral dosage forms.

You must have a Bachelor’s Degree, M.Sc., or Ph.D. in Pharmaceutical Sciences or a related field with a minimum of 5-10 years experience in formulation development in either Solid, Semi Solid and Liquid Formulation development. SOD is preferred and Generics experience is an asset.

Salary: $110-120K plus 20%.

Location: Florida

Call Jason Edgar for all the details at 416 225-2628, mailto:careers@jedgarcareers.com

SENIOR SCIENTIST, FORMULATIONS DEVELOPMENT, to $110K plus 15% bonus, Southern USA

Other responsibilities involve mentoring and leading a small team of Research Assistants, Research Scientists or Junior Scientists towards the development and technology transfer of solid oral dosage forms.

Salary: $100-120K.

Location: Florida

Call Jason Edgar for all the details at 416 225-2628, mailto:careers@jedgarcareers.com

MEDICAL LIAISONS for PHARMACEUTICAL and BIOPHARMA, to $100K plus bonus and car, Vancouver, Toronto and Montreal

We are currently seeking Medical Liaisons in Vancouver, Toronto and Montreal for Oncology and Respirology. A background in either therapeutic area with a minimum of a Master’s degree and at least 2-3 years experience in a customer facing role in the pharmaceutical or biotech industries is required.

As a Medical Liaison you will work to identify, develop and manage emerging untapped scientific opportunities for some blockbuster products in Oncology or Respirology. As well, you will effectively interface with internal Scientific Research and Therapeutic teams to ensure optimal implementation of regional initiatives.

You must have a University degree at the Master’s level or above in biological sciences, pharmacology, or pharmacy or be a PhD or MD with a background in Respirology or Oncology preferably.

Experience working in a pharmaceutical or biotech company as an MSL or in specialty hospital sales or as a Medical Advisor or senior clinical researcher is an asset.

Willingness to travel: up to 40% is required.

Email your CV in Word format to: Herb Botkin, hbotkin@sympatico.ca and call 416 225-8071 for all the details.

Our client, a global leader within the Pharmaceutical and Biotechnology sector, is currently searching for a Statistician to join a state of the art facility, to develop, test, and improve statistical methodologies. This is an opportunity to develop statistical methods for analyzing data assays.

Bring your applied statistical research experience to the forefront and enable us to set up an interview for you. This role requires an ability to improve statistical approaches by designing experiments in tandem with regulatory requirements and internal operating procedures. Your main responsibilities will be conducting and validating statistical analyses for the qualification and validation of analytical methods, as well as assay transfer/concordance studies.

Your research experience will enable you to liaise with Senior Scientists to explain your statistical findings in a concise manner. Bring your experience in designing experiments together with your solid programming skills in SAS and JMP and we have the perfect spot for you.

Educational requirements: Masters or PhD in statistics along with relevant work experience makes you an ideal fit for this exciting and newly created role.

If you are an outgoing, team player who can work independently and you believe in mutual respect for your colleagues and you have a good grasp of the French language, contact us immediately so we can begin the interview process.

Above all we are looking for a professional who is action oriented and can stay focused on the objectives of your department. You are not the type to sit back and wait for things to land on their desk, but rather you are a pro-active individual who will help all teams and all departments within the organization because your realize that your individual success is directly linked to your departments success and the organization as a whole.

Cris Murray 416 225-6386, Please email your updated CV in Word format to jedgar@sympatico.ca

PHARMACEUTICAL and BIOTECH

MEDICAL LIAISONS for PHARMACEUTICAL and BIOPHARMA COMPANIES to $110K plus car, Vancouver, Calgary and Montreal

We are currently seeking Medical Liaisons in Calgary, Vancouver and Montreal for Immunology.

DIRECTOR, LABORATORY OPERATIONS, $170K plus $80K bonus, South USA

CLINICAL DATA MANAGER, to $70K plus bonus, Toronto

CLINICAL DATA MANAGEMENT DIRECTOR to $120K plus bonus, Toronto

REGULATORY AFFAIRS ASSOCIATE/ Project Manager - $70K – Toronto.

TEAM LEADER ANALYTICAL R+D, $90 to $100K plus Bonus, Southern USA

PHARMA SCIENTIST, TECHNICAL SERVICES, to $85K plus bonus, South USA

QUALITY ASSURANCE MANAGER, $90 to $100K, Toronto

Salary range: $90 to $100K, Location: Toronto

QUALITY CONTROL MANAGER, PHARMACEUTICALS, $90 to 95K, Toronto

DIRECTOR, ANALYTICAL DEVELOPMENT, to $220K plus bonus, South USA

SENIOR MANAGER for HEALTH ECONOMICS and OUTCOMES in the PHARMACEUTICAL INDUSTRY, to $120K, Montreal

DIRECTOR of MARKET ACCESS for PHARMACEUTICAL INDUSTRY, to $150 plus 25% bonus, Montreal

MEDICAL LIAISONS for PHARMACEUTICAL and BIOPHARMA COMPANIES, to $120K plus bonus and car, Vancouver, Calgary, Toronto and Montreal

SENIOR MANUFACTURING ENGINEER to $125K plus bonus Florida

MEDICAL LIAISONS for PHARMACEUTICAL and BIOPHARMA, to $100K plus bonus and car, Vancouver, Toronto and Montreal