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).
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.
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
2-3 years of relevant experience in API research and development, formulation, analytical or regulatory affairs
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
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.
Our Client EBP is the most versatile family-owned distribution partner that provides a broad range of essential supplies & services for progressive commercial organizations throughout the eastern and domestic United States.
Since 1918, our Client has strengthened your ability to go forward – by making your supplies work harder and helping you work smarter.
As they head into a second century of business, the expert thinking, top brands, service and training you depend on are being expanded. A new Training Academy, an expanded ecommerce experience and new innovations from partners in the industry.