Director / Sr. Director, Manufacturing Sciences

Position Summary

The Director / Sr. Director, Manufacturing Science & CMC Operations will support the cross-functional technical and operational work that connects Drug Substance Process Development (PD), Analytical Development (AD), and our external manufacturing partners across the late-stage development of bispecific monoclonal antibody programs.

Responsibilities

• Manufacturing Science & CDMO Technical Oversight

• Serve as a sponsor-side technical point of contact for manufacturing executed at CDMOs, providing technical oversight
• Provide on-site technical presence (person-in-plant) during key manufacturing activities — engineering runs, process performance qualification, and process change implementation
• Review CDMO-generated batch records, in-process data, deviations, and investigations with a sponsor lens; contribute technical assessments for deviations, CAPAs, and change controls
• Establish and own a continued process verification (CPV) / process monitoring program, trending process and analytical data across campaigns to monitor consistency, robustness, and ongoing comparability
• Identify process improvement opportunities arising from this monitoring and from manufacturing experience, and support their development in partnership with PD

• CMC Documentation Integration & Technical Writing

• Support the integration, consistency, and quality control of the CMC document set across PD and AD inputs — including Module 3 sections of INDs, CTAs, and IMPD updates, with review and QC of CDMO-generated content
• Review and integrate CDMO-generated documents (e.g., tech transfer plans and reports, process validation documentation, and other technical summaries) into clear, defensible regulatory content
• Draft and help finalize responses to health authority RFIs and CMC questions
• Ensure consistency, scientific accuracy, and regulatory alignment across all CMC documents for both programs

• Technology Transfer & Phase 3 / PPQ Readiness

• Career coordination and support technology transfer activities as the Phase 3 processes are defined and implemented at CDMOs
• Support manufacturing readiness and process performance qualification (PPQ) planning, and author or contribute to PPQ protocols and reports from a sponsor-side technical standpoint
• Plan, execute, and interpret process and analytical comparability as drug substance processes move between sites and scales, building defensible bridges from earlier clinical material to Phase 3 and commercial supply

• Cross-Functional Collaboration

• Contribute to control strategy and specification justification for drug substance and drug product quality attributes, in partnership with AD and QC
• Partner across PD, AD, Program Management, Quality, and Regulatory CMC to advance CMC deliverables
• Support inspection and submission readiness from a CMC technical and documentation standpoint

Qualifications

• Experience with monoclonal antibodies or complex biologics required; bispecific antibody experience a strong plus

• Advanced degree (MS or PhD) in biochemistry, chemistry, chemical/biochemical engineering, or a related life sciences discipline; BS with extensive relevant industry experience considered

• 10–12 years of CMC development experience for biologics, including hands-on background in drug substance process development, analytical development, or manufacturing science / technical operations

• Solid command of ICH guidelines (Q6B, Q8, Q9, Q10, Q11) and GMP requirements for biologics

• Familiarity with control strategy principles and specification setting for biological products

• Strong technical judgment, with the ability to manage external technical relationships and to influence cross-functionally without direct authority

• Self-directed and effective operating with autonomy in a lean, fast-moving organization

• Effective in both structured late-stage / commercial environments and lean, earlier-phase or small-company settings

• Willingness to travel to CDMO sites (~10–20% of time); international travel likely

Preferred Experience

• Experience working in or with a fully outsourced (CDMO-based) development model

• Direct MSAT or technical operations experience supporting late-stage or commercial biologics manufacturing

• Prior involvement in BLA or MAA submissions for biologics

• Experience supporting process performance qualification (PPQ) and process validation for biologics

About Angitia

Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis, osteogenesis imperfecta (OI), and spinal fusion. Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization with offices in Westlake Village, CA and Guangzhou, China that is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group.

Benefits

• Medical, dental, and vision coverage for employees and their eligible dependents

• 401(K) Retirement Plan with Company match

• Company paid Long Term Disability Coverage

• Company-paid life Insurance & AD&D Coverage

• Voluntary Life Insurance & AD&D Coverage

• Employee Assistance Program (EAP)

• Company-paid Holidays

• Vacation

• Paid Sick Leave

• Telecommunication Monthly Stipend

• Work-From-Home Equipment Reimbursement