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SD/AVP of Biologics Process Development - (Princeton)
SD/AVP of Biologics Process Development - (Princeton)Hengrui Pharma • Princeton, NJ, US
SD / AVP of Biologics Process Development - (Princeton)

SD / AVP of Biologics Process Development - (Princeton)

Hengrui Pharma • Princeton, NJ, US
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Strategic & Technical Leadership

  • PD

Deep Domain Expertise & Oversight

1. Upstream Process Development

2. Downstream Process Development

CMC CMC Integration

  • CQAs

    • Team Management & Development

    Tech Transfer & Scale-Up

  • GMPCDMOs
  • GMP

    • Global Regulatory Strategy

  • INDBLAMAA
  • PPQ

    • Operational Excellence

  • COGs
  • 15 8
  • ADC
  • BLA / MAA CMC
  • FDA EMAICH

    • English Job Description (JD)

    Job Responsibilities

    Location : Suzhou / Guangzhou / Lianyungang

    1. Strategic & Technical Leadership

  • Provide 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 & Oversight

    1. Upstream Process Development

    Provide 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 Development

    Provide 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 Integration

  • Serve 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 & Development

  • Lead, 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-Up

  • Own 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 Strategy

  • Lead 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 Excellence

  • Manage the departments budget, resources, and timelines effectively. Champion initiatives to improve efficiency, reduce COGs, and implement new technologies.

    • Qualifications

    1. Education Background

    Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, or a directly related field.

    2. Relevant Experience

  • Minimum 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 organization.

    • Competency Requirements

  • Exceptional 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.
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    Princeton • Princeton, NJ, US