Associate Director, Biologics Drug Substance

About the role

This role is an individual contributor position and serves as a subject-matter expert (SME) in upstream and downstream processes for outsourced drug-substance manufacturing, technology transfer, life cycle management, and global regulatory submissions of complex Biologics, monoclonal antibodies, enzymes, bi-specifics, ADCs, and recombinant therapeutics.

Primary Responsibilities

• Technical Oversight & Manufacturing Support

• Serve as primary technical interface with global CMOs supporting Drug Substance manufacturing.
• Lead investigations for technical deviations, root cause analyses, and CAPA implementation.
• Supervise campaign readiness, change management, and process development discussions.
• Lead internal technical meetings and contribute to Virtual Plant Teams (VPTs) to manage timelines, supply impact, risks, and budget.

• Technology Transfer, Scale-Up & Validation

• Oversee process scale-up, technology transfer, PPQ readiness, and validations across CMO sites.
• Author and review validation protocols, reports, and technical documentation.
• Drive continuous improvement initiatives across upstream and downstream processes.
• Drive standardization and knowledge-sharing practices across sites and the global network.

• Lifecycle Management & CPV

• Own lifecycle management strategies for assigned commercial products across manufacturing sites.
• Establish and maintain robust process monitoring and Continuous Process Verification (CPV) strategies.
• Perform statistical analysis on campaign data to create and analyze process trends and control charts.

• CMC & Regulatory Support

• Author and review CMC sections for global regulatory submissions (NDA, BLA, MAA, ND, IPMD).
• Support filing in new markets and impact assessment to post-approval changes.
• Support responses to health authority questions related to manufacturing processes and controls.
• Ensure manufacturing and validation strategies align with GMP, ICH, and global regulatory expectations.

• Technical Leadership & SME Role

• Lead process risk and criticality assessments to identify gaps and define improvements.
• Support business development and technical due diligence activities as needed.
• Stay current with scientific literature, evolving technologies, and MSAT best practices.

Education and Required Skills

• Academic Background:

• Ph.D. with 5 years of experience or M.S. with 8 years of experience preferred, B.S. with 10 years of experience required in Chemical Engineering, Biochemistry, Biotechnology, Synthetic Organic chemistry or Pharmaceutical Sciences.

• Technical Expertise

• Extensive hands-on experience in upstream (microbial fermentation & mammalian cell culture) and chromatography, UF/DF, Viral clearance, Depth filtration techniques in protein purifications.
• Proven experience of working with Bioconjugation techniques, linker-payload development, HPAPIs for clinical/commercial ADC manufacturing is desirable.
• Experience in synthesis, purification, and characterization of antibody drug conjugates and enzymes is preferred.
• Deep understanding of single-use technologies, microbiology, Extractables and Leachables (E&L) Scale-down models (SDMs), DoE, QbD, regulations, and process control strategy.

• Regulatory and Compliance

• Proven track record in drafting and reviewing regulatory filings (MAA/NDA/BLA and Variations) and responding to Health Authority queries.
• Experience in authoring/reviewing dossier sections & reports. Strong understanding of cGMP & ICH guidelines.

• Data Analysis and Problem Solving

• Expertise in data management, statistical, and visualization tools such as JMP or Minitab.
• Advanced proficiency in problem-solving frameworks (e.g., Ishikawa, Kepner-Tregoe, 5-Why).

• Collaboration & Communication

• Proven experience collaborating with CMOs and external partners.
• Proficient in strategic planning and managing multiple complex projects simultaneously.
• Strong negotiation and influencing skills with the ability to work effectively in interdisciplinary teams.
• Excellent skills in drafting development reports, summaries, and technical presentations.
• Excellent verbal and written English skills, including active listening, attention to detail, and the ability to draft technical reports and presentations.
• Ability to thrive in dynamic environments that embrace change, risk, and flexibility.