The Manager API Sciences is responsible for the management of DMF technical issues related to selected API’s and Suppliers from the adoption of new products through product approval. This individual will work with the API manufactures to resolve all the DMF related deficiencies prior to the ANDA filing and through the approval.
The Manager API Sciences reports to the Vice President, Analytical Development or designee.
- Support Supplier Change Notifications as needed (evaluation of vendor changes, change controls for specification and methods, full testing of new materials).
- Works in concert with the R&D API Sourcing team once new projects have been identified for development but prior to project initiation.
- Manages the procurement and distribution of API Supplier samples and documentation (Technical Package, DMF, API lots, Reference Standards, Polymorph Standards etc.)
- Identifies and assists with the mitigation of risks associated with selected API’s, by leading the effort to resolve quality, regulatory and compliance issues identified by the R&D teams.
- Prepares/reviews API related CMC documents for ANDA submissions, responses for deficiency letters, and product development reports.
- Interprets complex data and solves scientifically challenging problems by providing direction and leadership to R&D development teams as needed.
- 12 – 16 years of relevant experience in API research and development, with a BS degree in Organic Chemistry.
- 6 – 10 years of relevant experience in API research and development, with a MS degree in Organic Chemistry.
- 4 – 8 years of relevant experience in API research and development, with a Ph.D. in Organic Chemistry.
- 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 II API DMF under GDUFA).
- Working and thorough knowledge of analytical chemistry and associated analytical instrumentation and techniques, in particular NMR, LC/MS/MS, IR, XRPD.
- 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 cGMP/EHS/DEA regulations as well as the filing requirements for generic ANDAs.
- Highly motivated with the ability to manage in an environment with a high degree of change.
- Excellent interpersonal skills to deal with internal and external stakeholders across many organization levels and functions.
- Good organizational skills and the ability to juggle multiple projects based on the company needs.
- Strong communication skills, both verbal and written.
- Some travel required.
We are an EEO Employer.