Apotex Inc. Pre-Formulation Development Chemist in Richmond Hill, Ontario


About Apotex:

Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!

We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds. We’d love to hear how you could contribute to the team!

Job Summary:

The chemist, Pre-formulation Development is responsible for all activities leading to the development of a stable and bio-equivalent product for a large variety of liquid dosage forms.

Job Responsibilities:

  1. May perform quantitative analysis of the ingredients in Innovator products if required.

  2. Possess fairly good understanding of PD lab test procedures

  3. Perform compatibility and provide summary report on completion.

  4. Comparative study of formulation trials with Brand Leader product.

  5. Perform routine testing of formulated product in compliance of special regulatory submission requirements eg, BA/BE studies for nasal sprays.

  6. Perform testing of packaging components as per pre-established methods.

  7. Perform testing of complaint samples as required.

  8. Development of specifications for packaging materials, and raw materials using established specifications.

  9. Release of packaging components for stability batches if required.

  10. Develop and write-up of PM, GM, TM and PD test methods with assistance.

  11. Under supervision conduct experiment in trouble-shooting of formulations, OOS results and packaging components.

  12. Validation of analytical methods if required.

  13. Provide input into departmental SOP and reference procedures.

  14. Perform all work in accordance to SOP, GMP and SWP and all company policies.

  15. Possess good understanding of regulatory requirements.

  16. Communicates effectively across all levels of the department and external customers.

  17. Work under minimal supervision.

  18. Attend department meeting and internal training meetings.

  19. Any other duties as assigned.

Technology/Instrumentation (type & complexity)

  1. HPLC, GC, TLC, UV-Vis, FT-IR, Karl Fischer Tester, Titrator, High Speed Photography/Laser instrumentation, Laser Particle Size Analyser

  2. In addition, more complex techniques as required, including any new instrumentation.

Experimental or Methodological Design (if applicable)

  1. Review draft test methods and procedures prior to use in the laboratory.

  2. Generate test protocol if required.

  3. Write up technology transfer document.

  4. Under minimum supervision perform laboratory testing.

Relationship with Internal/External Customers & Stakeholders

  1. Provide technical support for chemists within the department or for other departments.

  2. Works as a member of a team to achieve all outcomes.

Problem Solving Analysis

  1. Provide feedback to senior levels of any technical related issues.

  2. Identify the problems associated to the method /procedure and improve the method/procedure with minimum supervision.

  3. Responds to conventional queries of higher level team members and providing them with appropriate information.

  4. Provide feedback to senior levels of any technical related issues.

  5. Utilizes more complex problem-solving skills to identify root causes of issues with internal customers and determining appropriate solutions.

Decision Making/Autonomy

  1. Refer recommendations to next level on more complex issues

  2. Demonstrates corporate values in the performance of their work and in interactions with others.

Leadership/Professional Development of Self & Others

  1. Maintains up-to-date training on company SOPs, cGMPs, and regulatory requirements relating to all aspects of documentation within the department.

  2. Continually upgrades skills and knowledge of skills required in the preparation of documents, and in knowledge of pharmaceutical development processes.

  3. Seeks performance feedback from peers and supervisor in order to identify performance gaps and arrive at a plan for personal development.

Compliance & Due Diligence

  1. Develops and revises Standard Operating Procedures relating to Formulations Development, as required.

  2. Ensures that documentation is in compliance with cGMPs, SWPs and SOPs as applicable.

  3. Performs all work in accordance with all established regulatory and compliance and safety requirements.

  4. Practises due diligence.

Job Requirements:

  • University degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering or related science

  • Three to five years of working experience, preferably in a pharmaceutical development environment

  • Sound working knowledge of formulation equipment and analytical equipment.

  • Possess good knowledge of regulatory requirement in various dosage forms for sterile and non-sterile products

  • Strong verbal and written English communication skills

  • Well-developed interpersonal and team work skills

  • Understanding of GMPs, SOPs, USP, BP, SWPs

Please note that employment is conditional upon the successful completion of a background check.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

System ID: 2016-4895

Job Type: Contract

Career Level: Experienced