Director, Drug Product Development
The ideal candidate will take on the following tasks:
· Act as the subject matter expert in PFS process development and manufacturing.
· Drive late-phase and commercial launch strategy for PFS development and manufacturing.
· Lead drug product tech transfer, process development, and GMP manufacturing operations, including person-in-plant support.
· Oversee CDMO performance, ensuring adherence to deliverables and timelines.
· Apply QbD principles to conduct risk assessments and shape phase-appropriate manufacturing strategies across process transfer, scale-up, PPQ, and commercial readiness.
· Partner with drug product and device teams to advance presentations across vials, PFS, autoinjectors, and emerging delivery technologies.
· Work cross-functionally with Quality and external partners on batch record review, deviation resolution, and regulatory filings including INDs, IMPDs, and BLAs.
The ideal candidate will possess the following qualifications:
Gables Search Group headquartered in Cleveland, Ohio has been a leader in search and placement nationwide since 2002. Our company specializes in both direct and contract (temporary) staffing in all industries and disciplines.
At Gables Search Group, we connect exceptional professionals with outstanding organizations. Our commitment to integrity, excellence, partnership, innovation, and respect sets us apart. With a personalized approach to recruitment, we ensure the perfect match between candidates and employers.
Whether you are a talented professional seeking new opportunities or an organization looking to build a high-performing team, Gables Search Group is here to guide you through the journey. Our success is built on the success of our clients and candidates, and we are dedicated to making a positive impact on the careers and businesses we serve.