Director – Manufacturing Sciences

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🔥 23 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $210k - $265k / year

⏰ Full Time

🟠 Senior

👔 Director

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Angitia Biopharmaceuticals

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $46M Series B on 2023-10

Biotechnology • Healthcare Insurance • Pharmaceuticals

Angitia Biopharmaceuticals is a clinical-stage biotechnology company founded in 2018, focused on the discovery and development of breakthrough therapeutics for serious musculoskeletal diseases. With a strong emphasis on innovation, Angitia aims to address unmet medical needs through their pipeline of therapeutics, including treatments for conditions such as Osteogenesis Imperfecta and Osteoarthritis. The company is devoted to fostering a culture of respect and equality, and is committed to employee growth and career development while delivering effective therapies to help patients in need.

📋 Description

• 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 • 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 • Coordinate 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 • 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

🎯 Requirements

• 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.

🏖️ 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