Director Product Development

Director, Product Development

Location: Exton, PA

Full-time

Frontage Laboratories

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

CMC

Our broad portfolio of CMC services covers drug product development comprising formulation development, novel drug delivery, analytical, scale up, and Phase I-II CTM manufacturing. In Q3 2024, we will relocate to a 46,000 SF greenfield, state of the art CMC site in Exton, PA that has the capability to manufacture Phase-III registration batches and commercial supplies. Our facilities house the latest formulation and analytical equipment for a broad range of dosage forms such as oral solids, sterile, nasal, Ophthalmics and topicals including API and product release, wide spectrum of analytical testing, ICH stability, and commercial testing. We also have robust characterization and analytical capabilities for large molecules and biologics.

Position Summary

Director, Product Development is a key leadership role in the CMC Business Unit at Frontage Labs reporting directly to Executive Vice President, Global CMC and CDMO Services and is responsible for all aspects of formulation development for IND, NDA, 505b(2), and ANDAs. The ideal candidate will also have experience in biologics (BLA) and collaborate with various stakeholders to develop a plan to offer development and manufacturing services in this new area. This role is both strategic and tactical to ensure CMC business unit stays ahead of the curve, foresees, and adapts to industry trends, and at the same time flawlessly execute on existing projects. The candidate will guide and mentor a team of R&D scientists to develop, scale up, technology transfer, and collaborate on Clinical Trial Material (CTM) manufacturing. The candidate will lead a team of 8-12 scientists for a variety of dosage forms such as sterile, oral solids, liquids, topicals, nasal, and Ophthalmics. This role is also responsible for project management, equipment selection, capability enhancement, and interfacing with new and existing clients. The candidate is expected to have strong technical, communication, and leadership skills to lead internal efforts and interface with Business Development and regulatory authorities.

Responsibilities

• Participate in new client calls and present formulation capabilities.
• Coach, mentor, and guide the scientists for formulation and process development, scale up, and technology transfer.
• Execute projects to meet timelines for client s regulatory submissions such as IND, NDA, and ANDA filings.
• Review and approve project plans for all dosage forms including manufacturing batch records and product development reports.
• Provide technical guidance to troubleshoot issues in formulation development and manufacturing.
• Identify new equipment and capabilities, prepare justification, collaborate with manufacturing and procurement to prepare Capex documents.
• Ensure teams comply with all relevant cGMP, GLP, DEA, and OHSA regulations.
• Work closely with the BD team on new client acquisition, review of contracts and scheduling client visits.
• Develop and maintain excellent working relationships with clients.
• Present webinars, and research at scientific conferences

Requirements

• Ph.D. in pharmaceutical sciences, or related field with 10+ years of relevant experience in pharmaceutical development
• Experience in product development and manufacturing of IND, NDA and ANDA products.
• Excellent oral and written communication skills as well as strong focus and attention to details.
• Experience in sterile product development is a must.
• Experience in large molecules is highly preferred.
• Prior experience of working at a CDMO is highly desirable.
• 5+ years of people management experience.
• Strong knowledge of cGMP regulations and working knowledge of US and EU sterile standards.
• Strong organizational and time management skills.
• Ability to work well in a team environment, eager, adaptable.
• Ability to multi-task and shift priorities.
• Demonstrated scientific creativity and technical proficiency.
• Independent and self-starting.

Salary and Benefits

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.