Description:
This role is responsible for providing the support and service to the R&D, analytical, regulatory and quality group throughout the product life cycle by coordinating within the internal team and with external raw material suppliers. This individual will be responsible for resolving all the technical issues of pharmaceutical ingredients (APIs), excipients and packaging material and to manage the drug master file (DMF).
Essential Functions:
- Manages the procurement and distribution of raw material samples and documentation (Technical Package, Drug master file (DMF), API lots, Reference standards, Impurity standards, Polymorph Standards etc.) in accordance with US FDA (Food & Drug Administration) and ICH (International Conference Harmonization) requirements
- Manages closely with the R&D, Analytical and Regulatory team once new projects have been identified for development for the qualification of raw m related to those products.
- Manages the Supplier Change Notifications (evaluation of vendor changes, change controls for specification and methods, full testing of new materials.
- Identifies and assists with the mitigation of risks associated with API's & other raw materials, by leading the effort to resolve quality, regulatory and compliance issues identified by the R&D teams.
- Reviews API & other raw material related CMC documents for ANDA submissions, responses for deficiency letters, and product development reports
- Analyses complex data and resolves scientifically challenging problems by providing direction and leadership to R&D development teams as needed.
Education:
- Bachelor’s Degree (BNBS) - Required
- Master Degree (MS[MA) Organic Chemistry, pharmaceutical analytics, regulatory affairs or an equivalent degree relevant to the pharmaceutical industry Required
Experience:
- 2-3 years of relevant experience in API research and development, formulation, analytical or regulatory affairs
Skills:
- Ability to manage in an environment with a high degree of change. - Intermediate
- Excellent interpersonal skills to deal with internal and external stakeholders across many organization levels and functions. - Intermediate
- Good organizational skills and the ability to juggle multiple projects based on the company needs. - Intermediate
- Strong communication skills, both verbal and written - Intermediate
Specialized Knowledge:
- Thorough understanding of chemical synthesis including possible side reactions and chemical degradation.
- Thorough understanding of API and impurity physical & chemical characterization and structural elucidation.
- Ideal candidate possesses thorough knowledge and understanding of API development and API DMF filing process (Type Il API DMF under Generic User Fee Amendment).
- Working and thorough knowledge of analytical chemistry and associated analytical instrumentation and techniques, in particular NMR (Nuclear Magn Resonance) [MS (Mass Spectroscopy) /IR (Infrared Spectroscopy), XRPD(X-ray powder diffraction).
- Ideal candidate possesses knowledge of generic drug development; equivalent experience and demonstrated skills/knowledge may be considered.
- Extensive knowledge of compendia, ICH and regulatory guidance requirements along with filing requirements for generic ANDAs.
Company Description:Our Client is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, their unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in their own laboratories. Their medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.