Dir./Sr. Director, Upstream Biologics Manufacturing

Position Summary:

The Dir./ Sr. Director, Upstream Biologics Manufacturing will provide technical and strategic leadership for outsourced upstream drug substance manufacturing, with primary responsibility for supporting late-stage clinical development and advancing biologics manufacturing processes toward commercial readiness. This individual will serve as the Company's upstream manufacturing subject matter expert and primary technical representative with Contract Development and Manufacturing Organizations (CDMOs/CMOs), ensuring reliable clinical supply while driving manufacturing execution, process characterization, technology transfer, process validation/PPQ, continued process verification, regulatory inspection readiness efforts, and preparation for commercial manufacturing.

The Dir./Sr. Director will serve as the upstream process SME across development, manufacturing, and partner closely with internal and consultant CMC resources, Quality, Regulatory Affairs, Supply Chain, Program Management, and external manufacturing partners to ensure robust, compliant, scalable, and reliable production of biologic drug substance. The role requires strong technical judgment, ownership, and the ability to influence and drive results in a highly outsourced operating model.

Essential Duties and Responsibilities:

• External Manufacturing Leadership

  • Serve as the technical lead and Company subject matter expert for upstream manufacturing activities performed at external CDMOs.
  • Lead the technical evaluation, selection, qualification, governance, and ongoing performance management of upstream CDMO partners.
  • Provide oversight of mammalian cell culture-based manufacturing processes from cell bank/seed train expansion through bioreactor production and harvest.
  • Review manufacturing readiness, campaign plans, batch records, production schedules, process performance, and manufacturing data to ensure successful execution.
  • Establish strong technical relationships with CDMO process development, manufacturing, quality, engineering, and project management teams; appropriately challenge and escalate technical or execution risks.
  • Provide technical input to scopes of work, manufacturing agreements, change orders, and contract discussions related to process requirements and CDMO capabilities.

  Process Monitoring and Technical Support

  • Review and assess batch records, process trends, deviations, investigations, and manufacturing performance data.
  • Lead technical troubleshooting during manufacturing campaigns and drive or support root-cause investigations for process deviations, non-conformances, and unexpected manufacturing performance.
  • Evaluate process performance metrics, including:
  • Cell growth and viability
  • Metabolite profiles
  • Process yields
  • Product quality attributes
  • Process robustness and consistency
  • Identify and implement appropriate process improvements while maintaining alignment with late-stage development, comparability, validation, and regulatory requirements.

  Technology Transfer and Process Validation

  • Avalo SME will lead the evaluation and implementation of upstream aspects of process transfers between development laboratories, pilot facilities, and commercial manufacturing sites at CDMO’s.
  • Support development and review of technology transfer packages, process descriptions, risk assessments, and comparability protocols.
  • Provide technical oversight during engineering, demonstration, PPQ, and validation batches.  Evaluate process performance data and recommend process improvements to increase reliability, yield, and consistency.
  • Ensure transfer of process knowledge and manufacturing controls to external partners.

  Quality and Regulatory Compliance

  • Ensure manufacturing activities comply with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, and internal procedures.
  • Review and approve:
  • Change controls
  • Deviations
  • CAPAs
  • Risk assessments
  • Batch records
  • Process characterization reports
  • Support regulatory inspections and audits involving external manufacturing sites.
  • Contribute to preparation of CMC documentation for regulatory submissions.

  Cross-Functional Collaboration

  • Collaborate with Quality Assurance and Quality Control to resolve manufacturing issues and maintain inspection readiness.
  • Work closely with Supply Chain and Program Management to support production planning and inventory requirements.
  • Provide technical updates and recommendations to CMC management team.

  Program and Vendor Management

  • Support selection, qualification, and ongoing management of CDMO partners.
  • Participate in governance meetings with external manufacturing organizations.
  • Track project timelines, deliverables, and manufacturing risks.
  • Develop mitigation plans for supply, technical, and operational risks.
  Support contract negotiations by providing technical input related to manufacturing capabilities and process requirements

Additional Skills, Knowledge, and/or Abilities:

• Technical leadership
• Strategic thinking and risk management
• CDMO relationship management
• Cross-functional collaboration
• Problem-solving and root-cause analysis
• Communication and presentation skills
• Regulatory and quality compliance mindset
• Ability to influence without direct authority

Education & Experience:

• Ph.D., M.S., or B.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Biochemistry, or a related scientific/engineering discipline.
• Typically 10+ years of progressive biopharmaceutical industry experience in biologics process development, technical operations, and/or GMP manufacturing; equivalent combinations of education and experience will be considered.
• Demonstrated experience supporting biologics development, including Phase 3 manufacturing and progression toward process validation and commercial readiness.
• Demonstrated experience leading or providing significant technical oversight of outsourced mammalian cell culture manufacturing at CDMOs.
• Experience with monoclonal antibodies, recombinant proteins, or other mammalian cell culture-based biologic products.
• Demonstrated experience with technology transfer, scale-up, process characterization, and process validation/PPQ.
• Experience leading manufacturing investigations, technical troubleshooting, process risk assessments, and change management in a GMP environment.
• Working knowledge of ICH, FDA, EMA, cGMP, and biologics manufacturing regulatory requirements.

Technical Expertise

• • Cell culture process development and scale-up
  • Single-use and stainless-steel bioreactor systems
  • Seed train expansion
  • Harvest operations
  • Process characterization and validation
  • Technology transfer methodologies
  • ICH, FDA, EMA, and GMP requirements
  • Familiarity with process analytical technologies and statistical process monitoring tools.
  • Experience reviewing manufacturing data and applying risk management principles (ICH Q9).
  • Knowledge of late-stage development and commercial manufacturing.
  • Prior experience overseeing manufacturing activities at multiple global CDMO sites

Location: This position is based in Chesterbrook, PA and offers a flexible hybrid work model with a minimum of 2 days/week in the office. 

Travel: This position requires up to 30% domestic and internation travel.