Scientific Leader

**About Apotex Inc.**

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**Job Summary**:
The Scientific Leader, Formulation Development Technical supports all activities required to develop, optimise and scale-up a stable solid dose formulation and to make it suitable for commercial production. This team draws on a large skill set to bring a project to the third and fourth NPD Milestones: Stable Formulation and Stability Start, and supports activities required to complete the final Milestone: Launch

The Scientific Leader, Formulation Development Technical (Formulation Development-Solid Dose) is responsible for the development and modification of pharmaceutical formulations and manufacturing processes in order to obtain a stable and bio-equivalent product.The Scientific Leader is responsible for developing new solid oral dosage forms, which have been selected and scheduled for development.

**Responsibilities**:

- Responsible for development and design of formulations for products selected for development.
- Conducts relevant patent searches on formulations. Reviews scientific literature and makes recommendations for formulation development strategies.
- Attends appropriate trainings, seminars and presentations to maintain expertise in formulations and related areas.
- Communicates with buyers and / or peers to ensure that APIs, excipients, tooling etc. are available for the project in required quantities, as and when needed.
- Liaises with the plant operation supervisors and scheduler to ensure that experimental trials / registration batches are planned and executed in a timely manner.
- Liaises with the documentation groups to ensure that early development trial documents, process evaluation and process optimization documents that are required for execution are made available as and when required.
- Coordinates with lab for sample requirement and provides timelines for testing of those samples.
- Reviews and evaluates data (e.g. dissolution, assay, content uniformity) on trials, and makes recommendations for bio/stability study batches, and communicates these recommendations with management / peers to get necessary clearance to proceed further.
- Liaises with the documentation groups to ensure that all master manufacturing and packaging documentation, batch documentation, and other related documents required through the duration of the project are made available as and when required.
- Applies Quality-by-design (QbD) principles to product development and tests the ruggedness of the formula by conducting suitable trials to study the impact of variations in the excipients within SUPAC guidelines / variations in manufacturing process parameters in order to recommend control strategy for CMAs and CPPs.
- Liaises with the documentation group to ensure that all scale up master manufacturing and packaging documentation and other related documents required for submission to regulatory agencies are made available as and when required.
- Works with Scientist to prepare Pharmaceutical Development Reports and other documents required for regulatory submissions and technology transfer.
- Responsible for responding to deficiency queries from regulatory agencies in timely manner.
- Possesses a detailed understanding of the theoretical principles for major manufacturing and a working knowledge of the equipment used in the manufacturing processes and ensures successful execution of experimental trials / registration batches on floor.
- Responsible for investigating issues with formulations & processes. Uses advanced techniques to identify root cause of issues and plan a course of action for further investigation and corrective action as required.
- Provides scientific and technical expertise and performs consultations on issues regarding formulation to other members of Formulation Development department and other departments within the company.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.

**Job Requirements**:

- Education
- Master’s degree or Ph.D. in Pharmacy or Pharmaceutical Technology, Chemical Engineering or related science.
- Knowledge, Skills and Abilities
- Excellent working and theoretical knowledge of different pharmaceutical sol