Location: Exton,PA, USA
Frontage Laboratories Frontage Laboratories Inc. (Frontage) is a global contract research, development, and manufacturing organization (CRDMO) with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several global locations and is headquartered in Exton, PA. Frontage's core competencies include full spectrum of pre-clinical and clinical development including chemistry and manufacturing controls (CMC), safety and toxicology, and bioanalytical services.
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
Requirements
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.
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