Associate Director, Manufacturing Science and Technology

New

Apogee TherapeuticsBiotechnology

Location: Remote, Availability to participate in calls across multiple international time zonesFull-TimeManager

Salary175,000 - 195,000 USD per year

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Job Details

Experience: 7+ years

Requirements

PhD in biology, chemistry, biochemistry, bio/chemical engineering, or relevant field or equivalent experience
7+ years of biologics development and manufacturing experience
Experience with late phase development and commercialization of monoclonal antibodies
Experience with upstream cell culture, downstream processing, solution prep, cleaning, automation, and data systems
Experience with tech transfer to CDMOs and supporting DS campaigns through scale up and PPQ
Experience with Person in Plant and pre-approval inspection support
Experience with process and economic modeling of DS manufacturing processes
Aptitude in collaborating with cross-functional partners
Excellent communication skills
Availability to travel up to 25% for site visits and mandatory in-person All Hands meetings

Responsibilities

Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment
Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics
Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners
Work closely with CDMO partners, providing technical oversight and leading investigations
Analyze process and manufacturing data to understand and optimize process performance
Develop process characterization and PPQ strategies and documentation
Support regulatory activities including submissions and site inspections
Liaise with DP, device development, and clinical supply chain for end to end product delivery
Develop and maintain cost of good models
Collaborate with TechOps team and author internal procedures/reports

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175,000 - 195,000 USD per year

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