Director – Manufacturing Sciences

🕒 Junho 23

🏄 California – Remoto

🏄 California – Remote

💵 $210.000 - $265.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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Angitia Biopharmaceuticals

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2018

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

💰 $46.000.000 Series B em 2023-10

Healthcare • Consulting • Biotechnology

Angitia Biopharmaceuticals é uma empresa de biotecnologia em estágio clínico fundada em 2018, focada na descoberta e desenvolvimento de terapias inovadoras para doenças musculoesqueléticas graves. Com um forte enfoque na inovação, a Angitia busca atender necessidades médicas não satisfeitas por meio de seu pipeline de terapias, incluindo tratamentos para condições como Osteogênese Imperfeita e Osteoartrite. A empresa se dedica a promover uma cultura de respeito e igualdade, e está comprometida com o crescimento e desenvolvimento de carreira dos colaboradores, enquanto oferece terapias eficazes para ajudar pacientes necessitados.

Descrição

• 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

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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