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Director of Drug Product Development (Semi-solids/Drug Delivery)–Top $$
Research Triangle Park, NC 27709 United States
Research and Development
Our client, Research Triangle Park, NC area pharmaceutical firm, is actively recruiting for a top-notch candidate to assume leadership role driving new product development on its R&D team. Company is developing a portfolio of semi-solid/topical products in the dermatological space. Extensive expertise with similar products will be essential.
Client will pay absolute top dollar (including relo) to attract and retain a star.
This company boasts unique technology that is the foundation for a rich and expanding pipeline. This Director of Product Development will play a critical role in building out that portfolio.
Key Things to Note:
- This Director will drive the formulation and development of new drug therapies (and delivery systems), based on the company’s platform technology. Right candidate will be an expert scientist who is also a skilled and practiced project manager
- This is an independent contributor role (at this time) but will involve extensive cross-functional leadership as well as oversight of vendors/consultants/CDMOs. Seek a superb leader of people and process
- These are dermatological products that use a variety of delivery technologies (tubes, pumps, etc.). Ideal candidate will offer an extensive background in drug development complemented by some familiarity with device development , including regulatory standards and practices
The role will involve advancing the Company’s formulation science required for the development of innovative pharmaceutical products as well as ensuring that appropriate technical strategies and timelines are in place to meet clinical supply and registration needs, and that production, technology transfer and regulatory outcomes meet or exceed industry standards. Specific duties will include:
- Provide drug product leadership on cross-functional project teams
- Lead development and implementation of new formulations, container closures and devices
- Educate cross-functional team participants in formulation development directives
- Lead the assessment of novel formulations and the development of innovative drug product delivery technologies (container closures and devices) including lab-scale and pilot-scale process development
- Drive cross-functional collaboration with key stakeholders to recommend product specifications
- Direct outsourced drug product development with CDMOs including:
- Budget development and invoicing
- Formulation development, container closure/device development
- Preparation of CMC programs for drug products in development
- Facilitate collaboration with both internal and external drug product analytical teams.
- Oversee drug product CMC aspects of regulatory submissions including collaborating with leadership on the active pharmaceutical ingredient and medical device teams.
- Serve as CMC leader for formulation development and coordinate related activities from early nonclinical and clinical development through registration.
- Collaborate with internal and external manufacturing teams to support clinical trial material supply as it pertains to internal process development, scale up and technology transfer and associated manufacturing processes, controls and supply chain
- Ensure cGMP compliance for all documentation relating to production operations including any supporting documents required for regulatory submissions
Targeted candidate will offer:
- MS or PhD in chemistry, chemical engineering, pharmaceutical sciences or a related discipline
8+ years of drug product development experience with particular expertise in semi-solid, topical products
- Experience with device/combination products preferred
- Demonstrated excellence leading development in pre-formulation chemistry, dosage form design , characterization, stability studies, and manufacturing processes of gels, ointments and/or semi-solid formulations
- Experience with both early and late phase development including scale-up and process validation , technology transfer and scale up, including oversight outsourced (CMO/CDMO) mftg and development vendors
- Working knowledge of packaging and labeling regulatory requirements.
- Expert knowledge of regulatory requirements and direct experience authoring CMC sections for regulatory submissions including INDs, IMPDs, ANDAs, and NDAs.
- Direct experience interacting with regulatory agencies
In addition to the scientific/technical requirements noted, we seek a progressive thinker who enjoys participating in an innovative, fast-paced, and creative work environment as well as a skilled and versatile project leader with the proven ability to effectively lead individuals and teams to achieve a shared mission.
This is an exciting time with an exciting company. We seek a forward-thinking challenger of the status quo will can have immediate impact. Rewards will be generous.
If interested, please forward Word resume for prompt consideration.
Frankel Staffing Partners proudly recruits on behalf of premier employers in the Triangle (and beyond). We specialize in Office Support, Life Science and other Professional Services positions. To view our current openings, please visit our website at www.frankelstaffing.com.
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