Lead Research Scientist, FD-ARPL-FDT AR
Apotex Inc.
Full time- 7+ years
- Not Disclosed
- Bengaluru, India
- Post Date: Apr 16, 2024
- End Date: Jun 16, 2024
- 7+ years
- Not Disclosed
- Bengaluru, India
- Post Date:Apr 16, 2024
- End Date: Jun 16, 2024
Skills:
- pharma
- Quality control
- Regulatory Affairs
Job Description:
Responsibilities
- Responsible for development & design of formulations for multiple products selected for development & conducting meeting with multidisciplinary teams.
- Conducts relevant patent searches on formulations. Reviews scientific literature & makes recommendations for formulation development strategies.
- Responsible to carryout Preformulation studies, manufacturing prototype batches & do the formulation development based on QbD approach.
- Attends appropriate trainings, seminars, & presentations to maintain expertise in formulations & related areas.
- Communicates with buyers & peers to ensure that APIs, excipients, tooling etc. are available for the project in required quantities, as & when needed.
- Liaises with the plant operation supervisors & scheduler to ensure that experimental trials / registration batches are planned & executed in a timely manner.
- Liaises with the documentation groups to ensure that early development trial documents, process evaluation & process optimization documents that are required for execution as required.
- Coordinates with lab for sample requirement & provides timelines for testing of those samples.
- Reviews & evaluates data analytical/ technical data on trials, & makes recommendations for bio/stability study batches, & communicates recommendations with management / peers to get necessary clearance to proceed further.
- Liaises with the documentation groups to ensure that all master manufacturing & packaging documentation, batch documentation, & other related documents required through the duration of the project are made available as & when required.
- Applies Quality-by-design (QbD) principles to product development & 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 & CPPs.
- Liaises with the documentation group to ensure that all scale up master manufacturing & packaging documentation & other related documents required for submission to regulatory agencies are made available as & when required.
- To prepare Pharmaceutical Development Reports & other documents required for regulatory submissions & 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 & a working knowledge of the equipment used in the manufacturing processes & 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 & plan a course of action for further investigation & corrective action as required.
- Provides scientific & technical expertise & performs consultations on issues regarding formulation to other members of Formulation Development & other departments.
- Works as a member of a team to achieve all outcomes.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, & Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics & Compliance Program, Global Quality policies & procedures, Safety & Environment policies, & HR policies.
- All other relevant duties as assigned.
Qualification & Experience
- Master’s degree or Ph.D. in Pharmaceutics or Pharmaceutical Technology or related science.
- 7-10 years of working experience in a pharmaceutical development environment with related experience in formulation development of solid oral dosage forms for regulated market, scale up and/or technology transfer.
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Salary
Not Disclosed
-
Role
Scientist
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Area of Practice
- Education and Research
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Experience
7+ years
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