Associate Director, Chemical Process Development & API Manufacturing
Reporting to the Head, CMC and Analytical Development, the Associate Director of Chemical Development and API manufacturing is responsible for all development and manufacturing activities related to the drug substance with a broad knowledge of drug development process. The Associate Director will support the achievement of operational objectives within CMC/Pharmaceutical Development, ensuring alignment to Trevena company strategy and objectives.
Specifically, the Associate Director of Chemical Development and API Manufacturing will be responsible for:
- API chemical process development and solid-state development/characterization in support of drug product development,
- Manufacturing of non-GMP and GMP API batches (clinical through commercial) and identification, selection, and sourcing of starting materials to support API manufacturing,
- Evaluation of stability data and impurity identification/synthesis, evaluation of physico-chemical data of lab scale/pilot scale batches and adjustment of processes and methods as needed,
- Leading/managing the DOE study to finalize the API process and the process validation,
- Developing/implementing strategies to reduce the COGS of API and regulatory starting materials (RSM) while also maintaining a robust supply of API and RSM,
- Preparation of CMC documents related to clinical trial applications and authoring Drug Substance section for IND, IMPD, NDA, and sNDA filings,
- Selection and management of CMOs, executing CMC activities,
- Collaboration with Internal Quality and Compliance department to assure that CROs are performing according to cGMPs,
- Interaction with analytical and drug product CMC team members to build the CMC development plan and ensure execution thereof,
- Representing the CMC team in the cross-functional development team(s),
- Observes all Trevena policies, SOPs and safety guidelines,
- Other duties as assigned.
Up to 10% domestic/international travel.
EDUCATION & EXPERIENCE
- PhD in chemistry or related field or equivalent,
- 8+ years of experience working in drug development, especially in small molecule drug substance development/upscaling,
- Experience in the preparation of drug substance development reports for the CMC section of IND/IMPD and/or NDA submissions,
- Experience working in a virtual organization and managing CROs.
KNOWLEDGE, SKILLS & ABILITIES
- Strong knowledge of functional area, including deep knowledge of physical chemistry, solid state chemistry, organic synthetic chemistry and reaction mechanisms,
- General understanding of related functional areas within and beyond CMC,
- Ability to ensure alignment of methods, techniques and functional objectives with company strategy and organizational objectives,
- Demonstrated understanding of drug development including knowledge of drug discovery, clinical trials, and regulatory requirements for GMP API, regulatory starting materials, and GMP process,
- Strong analytical skills with a demonstrated ability to think strategically,
- Strong problem-solving skills with a track record of identifying and implementing novel solutions,
- Solid negotiation skills in quotation and a persuasive project management style when working with CMO/CRO to achieve company’s business and technical objectives,
- Transparent and direct communication styles internally and externally,
- Able to work in a fast-pace and constantly changing working environment.
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