Executive Director Cmc, Late-Stage Biologics Development And Manufacturing

POSITION OVERVIEW:

In this role, you will manage the successful transfer of drug substance development and manufacturing processes from the early clinical stage to late-stage commercial CDMOs. You will play an integral role in supporting ongoing development/manufacturing activities while devising strategies toward successful technology transfer, execution of characterization, and PPQ campaigns. You will partner with internal and external stakeholders to plan, execute, and deliver key objectives as development proceeds from early to late-stage development. The ideal candidate will have extensive hands-on experience in cell line optimization, upstream and downstream development, GMP DS manufacturing, process characterization, validation preparation, and PPQ campaigns.

RESPONSIBILITIES:

• Oversee the transition of drug substance development and manufacturing from early stage into late-stage development, such as process characterization, pre-validation, and PPQ campaigns.

• Develop and refine upstream and downstream unit operations, ensuring scalability, reliability, quality, efficiency, cost-effectiveness, validation, and commercial readiness.

• Ensure facility fit and manage DS technology transfer from clinical to commercial DS CDMO, ensuring successful implementation and execution of key activities.

• Collaborate with upstream and downstream process development team members to optimize early-stage clinical DS processes while leading the technology transfer to commercial CDMOs.

• Serve as the subject matter expert, identify key risks, develop mitigation plans, and ensure DS manufacturing timelines and deliverables are aligned with program and corporate goals.

• Partner with members of the analytical team to finalize phase-appropriate methods and formulations with an eye on commercial readiness.

• Assist in OOS/OOT investigations in collaboration with appropriate internal and external stakeholders.

• Collaborate with stakeholders to track key activities, timelines, and budgets.

REQUIREMENTS:

• MS/PhD in biochemistry, biochemical engineering, biotechnology, or equivalent. Candidate must have 15+ (with an MS degree) or 10+ (With a PhD) years of experience in early/late-stage biologics process development, validation, and clinical manufacturing.

• Hands-on experience in upstream processes and downstream development and manufacturing of biologics (mAbs, fusion proteins) in a GMP environment.

• In-depth knowledge of cell culture development, media optimization, bioreactor engineering, scale-up studies, scale-down models, process monitoring, unit operations, control strategies, and technology transfer.

• Must have an in-depth understanding of process characterization, modeling, and validation studies via DoE, QbD, and other relevant data management/statistical tools.

• Must have direct experience managing process characterization, pre-PPQ planning, and PPQ campaigns through the transition of early-phase process development to late-phase process development (PCs, PPQs) with a focus on scalability, reliability, quality, efficiency, cost-effectiveness, validation, and commercial readiness.

• Significant experience managing global CDMOs involved in clinical and commercial DS manufacturing.

• Working knowledge of tools required for understanding product quality, formulation, analytical, release testing, and drug product development/manufacturing.

• Solid understanding of cGMP and global biologics regulatory landscape with experience authoring and reviewing CMC regulatory documents (IND, IMPD, CTA, and BLA).

• Proven track record of identifying and solving problems through analytical thinking, accountability, and communication skills.

• Must be able to inspire and build effective and meaningful relationships with internal and external stakeholders.

• Strong project management, organizational skills, and ability to handle multiple tasks in a fast-paced environment.

• Must be able to prioritize personal and professional objectives based on organizational, strategic, and corporate goals.