Process Development, Associate Director - Cell Line Development (CLD), Biologics

Role Summary

Process Development, Associate Director - Cell Line Development (CLD), Biologics

Responsibilities

• Lead phase-appropriate strategies to develop, select, and characterize stable, high-producing cell lines for monoclonal antibodies, ADCs and other biologics modalities.
• Evaluate, select and manage external capabilities for cell line development.
• Oversee and review all aspects of the CLD process, including vector design, transfection, clone screening, characterization and cell line stability studies.
• Ensure regulatory-compliant cell line development workflows, including clonality documentation and cell bank generation.
• Develop and manage project timelines and budget for CLD activites.
• Ensure project deliverables, quality standards, and timelines are met in alignment with internal program goals.
• Collaborate with internal cross-functional teams including Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs to ensure alignment and knowledge transfer.
• Review and approve technical protocols, development reports, and data packages provided by CDMOs.
• Provide scientific and strategic input into cell line platform development, technology evaluation, and implementation of innovation from external partners.
• Support regulatory submissions (IND/IMPD/BLA) by contributing to or authoring relevant sections and responding to agency queries related to CLD.
• Serve as a subject matter expert in regulatory agency interactions, audits, and inspections.
• Expected travel: 10-20% (domestic and international)

Qualifications

• PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences or related discipline with commensurate years of education and experience.
• Minimum of 8 years of experience in drug substance development and manufacturing. MS with 12+ years of relevant experience may be considered.
• Demonstrated expertise in cell line development for therapeutic proteins including antibodies, ADCs, and fusion proteins.
• Strong understanding of molecular biology techniques, vector construction, clone selection strategies, and cell line characterization methods. Familiarity with industry-leading expression platforms (e.g., GS, CHOZN, CHEF1, etc.) is strongly preferred.
• Knowledge of upstream process development and analytical methods related to CLD.
• Hands-on experience managing external CDMOs and navigating cross-functional and cross-organizational workflows.
• Experience in authoring and reviewing relevant CMC sections of regulatory filings (IND, BLA, etc.).
• Proven track record of delivering on complex biologics development programs.
• Excellent interpersonal, communication, and organizational skills.
• Ability to work independently, manage multiple projects simultaneously, and operate in a fast-paced environment.

Skills

• Cell line development for therapeutic proteins
• Molecular biology techniques, vector construction, clone selection
• CDMO management and cross-functional collaboration
• Regulatory filing support (IND/BLA/IMPD)
• Program leadership and project management

Education

• PhD in a relevant field (Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences) or equivalent combination of education and experience.