Director/Senior Director of Pharmaceutical Development
Reporting to the Head, CMC and Analytical Development, the Director/Senior Director of Pharmaceutical Development is an experienced pharmacist/chemist with a broad knowledge of drug development. The Director/Senior Director of Pharmaceutical Development will support the achievement of operational objectives within CMC/Pharmaceutical Development, ensuring alignment to Trevena company strategy and objectives.
Specifically, the Director/Senior Director of Pharmaceutical Development will be responsible for:
- Drug product formulation development and process development, including evaluation of physical characteristics of development API (solubility, particle size, etc.), evaluation of early clinical and non-clinical data (pK, tox., etc.) and stability data (potency, impurity/degradants, etc.) of lab scale/pilot scale batches and adjustment of processes and methods, as needed,
- Working within the team to identify and qualify vendors and third-party manufacturers,
- Manufacturing of non-GMP and GMP batches, including batches to support clinical trials,
- Oversee the labeling and distribution of clinical trial materials,
- Leading/managing the DOE study to finalize the DP process and process validation,
- Developing/implementing strategies to reduce the COGS of drug product,
- Preparation of CMC documents related to clinical trial applications and providing technical support for NDA and sNDA filings,
- Selection and management of contractors executing CMC activities – including development work, process scale-up and CTM manufacturing,
- Collaboration with internal Quality and Compliance department to assure that CROs are performing according to cGMPs,
- Interaction with analytical and drug substance 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
- PharmD, PhD in chemistry, related/equivalent qualifications,
- 10+ years of experience working in drug development, especially in drug product development/upscaling,
- Experience in the preparation of drug product development reports for the CMC section of IND/IMPD and/or NDA submissions,
- Experience working in a virtual organization and managing CROs,
- Experience with sterile injectable, solid oral, and alternative dosage forms.
KNOWLEDGE, SKILLS & ABILITIES
- Strong knowledge of functional area,
- General understanding of related functional areas,
- 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 INDs, IMPDs, and NDAs,
- Strong analytical skills with a demonstrated ability to think strategically,
- Deep knowledge of physical properties, pharmacology, clinical trial supply,
- 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.
Please fill out the form below to submit your application.