Director Process Development Jobs in Frederick, MD

The Cell Therapy Product Quality Leader (PQL)is a matrixed leaderresponsible forthe end-to-end product quality strategy and lifecycle management of autologous, allogeneic, and in-vivo cell therapy products. This role will provide technical and compliance oversight for advanced therapeutic modalities, including, but not limited to, drug substance, drug product, viral delivery systems (e.g.LVV, AAV), and gene-edited cell therapy products from clinical stage through commercialization. This role requires deep technical and complianceexpertise, strategic thinking, and cross-functional collaboration to ensure product quality, regulatory compliance, and lifecycle continuity are met andmaintained.

Main Responsibilities:

• Serve as the Qualityrepresentativeon the CMCTeamandlead the Product Quality Team (PQT)sub-team

• Serve as the single voice of Quality in liaising with the CMC ProgramLeadto communicate Quality deliverables, risks, changes, etc.

• Develop and implement the overallProduct Quality Strategyand phase-appropriate control strategies

• Ownandmaintainlot release and stability specifications for advanced cell therapy modalities

• Manage the full specification lifecycle-fromclinicalstage through commercial approval and post-approval maintenance

• Supportthe design and execution of analytical comparability studies supporting process and product changes for advanced cell therapy modalities; ensure scientifically sound strategies and data-driven conclusions

• Support the design and execution of process tech transfer and analytical method transferprotocols/reports for advanced cell therapy modalities

• Oversee the stability programfor advanced cell therapy modalities, in collaboration with Global Stability

• Oversee annual product reviews for commercial products

• Maintain theProduct Quality Risk Registertoidentify, mitigate, and escalate issues related to manufacturing, analytical methods, or supply chain

• Work cross-functionallyto develop and implement platform approaches for specifications, comparability, and stability to enable consistent, scalable practices across multiple cell therapy products

• Author and review CMC sections for global filings, includingINDs, BLAs, and MAAs; manage responses to health authority queries

• Stay current on emergingprocess &analytical technologies and evolving regulatory expectations

• Partner closely with Process Development,Analytical Sciences, Supply Chain,Quality, Regulatory Affairs, Program Management, and other impacted stakeholders to ensure alignment with development milestones and commercial objectives

• Acts as a Subject Matter Expert (SME) during health authority inspections (e.g., FDA, EMA) for productquality-specificinquiries

• Review and evaluate major process changesto ensure noimpacttoproduct safety and efficacy

Education, Qualifications, & Experience:

• Bachelor's or Advanced degree (MS/PhD preferred) in Life Sciences or Engineering (e.g., Biology, Biochemistry, Chemical Engineering)

• 10+ years in the biotechnology or biopharmaceuticalindustry, with at least 3-5 years in aCell & Gene Therapy (CGT)orBiologics leadership role

• Deep understanding of globalcGMP regulations(FDA, EMA, ICH)includingphase-appropriate requirements for clinical vs. commercial products

• Demonstratedrecord of authoring CTD sections for IND, BLA/MAA, and/orpost-approval submissions

• Expertisein analytical method validation, process development, tech transfer, and viral vectors (e.g.LVV)

• Expertisein designing and executing product& processcontrol and comparability strategies

• Demonstratedability to clearly articulate complex technical concepts to cross-functional, senior management,and regulatory audiences

• Demonstrated success in a fast-paced, matrixed environment with a collaborative, problem-solving mindset, including anability to influence diverse stakeholders and drive decision-making without direct authority

The annual base pay for this position ranges from $167,595.20 - 251,392.80. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.