Deputy Manager- Formulation Development, Injectables

Job Summary

To plan, execute , supervise the drug product development activities and to ensure proper documentation of dosage form as per requirements of the global standards.  Would be involved in end to end product development and life cycle management of the drug products per global regulatory standards. This role required the management of team members and establish  day to  day operational procedures  for smooth product development as per the requirements of Apotex Research Pvt. Ltd.

Job Responsibilities

1. Innovate and/or assess formulation methodologies for injectable, solid, liquid and ophthalmic formulation development
2. Responsible for drug product development to exhibit batch execution and to support for regulatory filing
3. Prepare plan for development of drug product and ensure successful completion of the same
4. Ensure timely completion of early product development activities viz Pre-formulation studies, innovator/reference product procurement and characterization, resources procurement, license application etc.
5. Conduct literature survey and compile the scientific findings per product
6. Development of robust formulations and processes through optimization, by applying QbD principles
7. Review and compilation of the developmental raw data and exhibit batch stability data
8. Coordination with different cross-functional teams like AD, procurement, QA, packing, regulatory affairs, project management for smooth development and project execution
9. Provide necessary inputs and extend support to procure API, raw materials, and packing materials for development batches
10. Report to next level manager regarding day to day activities.
11. Coordinate for successful installation and qualification of equipments
12. Design and authorization of SOPs and ensure compliance as per SOP
13. Coordination with external labs and provide necessary inputs successful completion of studies (microbiology studies, filter validation studies etc..)
14. Coordination with internal tech tranfer person and CMO team for successful technology transfer of developed formulations
15. Planning and execution of product development studies of assigned dosage forms
16. Preparation and review of study protocols and reports, product development report, MFR, SOP, etc.
17. Manufacturing of lab scale batches and conduct formula and process optimization studies
18. In coordination with analytical team, ensure timely completion of formulation and stability sample analysis and compile and assess data to present in tech review meeting
19. Issuance, maintenance, writing, review of raw data, completeness check and archival of laboratory notebook
20. Execution of tech-transfer and monitoring of scale-up/exhibit/process validation batches at plant and review and compile engineering and exhibit batch stability data
21. Coordination with vendor and internal service engineer for installation, calibration, maintenance and trouble shooting
22. Take up any other work as allotted per department requirements.
23. To support process validation batches, if required and for regulatory filing

Job Requirements

• Education
  • M Pharma in Pharmaceutics or Ph.D in Pharmaceutics (with 8 to 13 years of progressive  experience)
• Knowledge, Skills and Abilities.
  • Having well versed knowledge on regulatory guidelines viz., US, Canada, EU, TGA
  • Having parenteral and ophthalmic product development experience is a must
  • Lab activities , functional process design and team management work experience is must
  • Complex dosage forms development handling experience is advantageous
  • Able to priortise the task, best in effective planning of work activities to meet the timelines.
  • Must have knowledge on handling of machinery/equipment related to parenteral dosage form
  • Must have experience in development and tech-transfer of injectable, solid, liquid and ophthalmic drug products
  • Effective command over verbal and written communication with good interpersonnel skills.
  • Proficient in MS office tools.
  • Knowledge on preparation of various documents like SOPs, formats, protocols, reports etc.
• Experience
  • Minimum 8 to 13 years of progressive experience in Injectable, solid, liquid, complex and Ophthalmic formulation development.
  • About 5 to 7 years of manufacturing experience of submission, and commercial batches at CMO