Director, Bioprocessing Manufacturing Science and Technical Support

Director, Bioprocessing Manufacturing Science and Technical Support

Anagram Therapeutics, a clinical stage, pipeline company, is seeking a highly motivated individual to join our CMC team to advance multiple enzyme-based oral therapeutics toward pivotal clinical trials and commercialization.

The Director of Bioprocessing MSAT is a key leadership position responsible for overseeing all Manufacturing Science and Technology (MSAT) activities across external biomanufacturing sites (CDMOs) for outsourced process development and GMP manufacturing. This role ensures effective technology transfer, regulatory compliance, and continuous process improvement to deliver clinical supplies, and support technical and GMP aspects of process validations and commercial launch preparations.

The position will lead external bioprocessing scale‑up and transfer projects, manage MSAT project teams, and collaborate cross‑functionally with Anagram’s technical, quality, and regulatory leads to meet program objectives. Depending on the balance of in‑house and outsourced projects, the position will also design and conduct process development experiments at Anagram facilities.

• CDMO Process Monitoring & Support:
  Collaborate with bioprocessing CDMOs and internal team members to deliver experimental plans, protocols, reports, engineering / master batch records, and reviewed executed batch records. Provide real‑time technical oversight during manufacturing campaigns, ensuring process adherence and rapid resolution of technical issues related to process, supportive utilities and facilities, and Quality Systems.
• Deviation Investigation & Troubleshooting:
  Lead process risk identification, assessments, risk mitigations, root cause analysis, and CAPA implementation.
• Data Aggregation & Continuous Process Verification:
  Aggregate and analyze process and analytical data from CDMOs to support lifecycle management, process trending, and regulatory reporting.
• Tech Transfer Strategy & Execution:
  Lead planning and execution of technology transfers for DS, DP, and packaging processes to CDMOs, or within CDMOs R&D to plant operations, ensuring knowledge capture, documentation, and cross‑functional alignment.
• Process Fit & Scale Translation:
  Assess and lead process scale‑up and adaptations to commercial‑scale equipment, ensuring process robustness and product quality.
• Regulatory Submissions & Inspection Support:
  Prepare and review technical documentation for regulatory filings, respond to agency queries, and serve as SME during inspections and audits.
• Cross‑Functional Leadership:
  Foster collaboration with CDMO and Anagram colleagues in Process Development, Analytical Sciences, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure seamless execution of MSAT responsibilities.
• Team Development:
  Build, mentor, and lead a high‑performing MSAT team comprised of in‑house and contract resources, fostering technical excellence, a culture of continuous improvement, close collaboration, and shared ownership.
• Process Validation Lifecycle Oversight:
  Lead pre‑commercial process validation strategy development, including process design, assignment and testing of critical process parameters (CPPs), drafting PPQ (Process Performance Qualification).

• Advanced degree (PhD, MSc, or equivalent) in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline.
• 15+ years of experience in MSAT or technical operations within the biopharmaceutical industry.
• Proven track record managing technology transfers, process validation, and commercial manufacturing at CDMOs.
• In‑depth knowledge of cGMP, ICH, EU/FDA regulatory requirements, and validation lifecycle management.
• Experience writing regulatory submissions (Module 3/CMC).
• Demonstrated ability to lead cross‑functional teams and manage complex projects in a matrixed, global environment.
• Excellent communication, writing, negotiation, and stakeholder management skills.
• Fluent in English; additional European languages are a plus.
• Willingness to travel within US, Europe and globally as required.
• Technical Leadership:
  Deep expertise in biopharmaceutical process…