SD/AVP of Biologics Process Development - (Princeton)

Strategic & Technical LeadershipPDDeep Domain Expertise & Oversight1. Upstream Process Development / 2. Downstream Process DevelopmentCMC CMC IntegrationCQAsTeam Management & DevelopmentTech Transfer & Scale-Up GMPCDMOs GMP Global Regulatory StrategyINDBLAMAA PPQOperational ExcellenceCOGs 15 8 ADC BLA/MAA CMC FDA EMAICH English Job Description (JD)Job ResponsibilitiesLocation: Suzhou/ Guangzhou/ Lianyungang1. Strategic & Technical LeadershipProvide expert scientific direction and oversight for the entire Process Development organization.Develop and implement a forward-looking PD strategy that incorporates advanced technologies for next-generation biologics and complex molecules.Establish platform processes while driving innovation to tackle molecule-specific challenges (e.g., product-related impurities, aggregation, low expression titers for complex formats).2. Deep Domain Expertise & Oversight1. Upstream Process DevelopmentProvide expert guidance on advanced cell culture technologies, including high-throughput clone screening, media/feed optimization, perfusion process development, and process intensification strategies to achieve best-in-class titers and product quality.2. Downstream Process DevelopmentProvide expert guidance on purification process challenges specific to complex molecules, including platform process optimization, novel chromatography resin evaluation (e.g., multi-modal), and designing robust viral clearance strategies. Deep knowledge of handling high viscosity, low stability, or heterogeneous products is essential.3. CMC IntegrationServe as the ultimate technical authority for Process Development, ensuring seamless integration with Cell Line Development, Analytical Development, and Formulation teams to define critical quality attributes (CQAs) and establish a holistic control strategy.4. Team Management & DevelopmentLead, mentor, and inspire a large, high-performing team of scientists and engineers across upstream, downstream, and tech transfer functions.Foster a culture of scientific excellence, innovation, accountability, and continuous learning. Attract, develop, and retain top-tier global talent.5. Tech Transfer & Scale-UpOwn the strategic oversight of all technology transfers to internal GMP manufacturing sites and external partners (CDMOs). Ensure processes are scalable, reproducible, and compliant with global regulatory standards.Provide expert troubleshooting support during GMP manufacturing campaigns.6. Global Regulatory StrategyLead the technical authorship and review of the Process Description and other critical sections of regulatory filings (IND, BLA, MAA).Define the process validation strategy (PPQ) and provide strong scientific justification for process parameter ranges during health authority interactions.7. Operational ExcellenceManage the departments budget, resources, and timelines effectively. Champion initiatives to improve efficiency, reduce COGs, and implement new technologies.Qualifications1. Education BackgroundPh.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, or a directly related field.2. Relevant ExperienceMinimum of 15 years of extensive and progressive experience in biologics process development, with at least 8 years in a senior leadership role managing managers and large, multi-disciplinary teams.Deep, hands-on technical expertise is non-negotiable. Must have a proven track record of:Developing and scaling upstream processes for complex molecules (e.g., bispecifics, ADCs, fusion proteins) addressing challenges like chain mispairing, product heterogeneity, and low expression.Developing and scaling downstream purification processes for complex molecules, with proven experience in solving challenges related to aggregation, product-related impurities, and unique separation techniques.Direct experience leading the CMC development of at least one complex biologic molecule from late-stage development through to BLA/MAA submission and approval is highly desired.Expert knowledge of global regulatory requirements (FDA, EMA, ICH) and experience interacting directly with health authorities.Demonstrated success in building, mentoring, and leading a world-class process development petency RequirementsExceptional strategic thinking, problem-solving, and decision-making skills, with a focus on data-driven outcomes.Outstanding communication and stakeholder management skills, with the ability to articulate complex technical concepts to executive leadership and cross-functional partners.

Created: 2025-09-24