Apogee Therapeutics · 17 hours ago
Associate Director, QC Manufacturing Support
United States
Full-time
Remote
Lead/Staff, Director/Executive
$160K/yr - $180K/yr
10+ years expApogee Therapeutics, Inc. is a biotechnology company focused on developing innovative biologics for various inflammatory and immunology conditions. The Associate Director, QC Manufacturing Support will manage GMP raw materials testing and support analytical testing activities, ensuring compliance with regulatory expectations and quality management systems.
BiotechnologyLife ScienceMedicalTherapeutics
Responsibilities
Author internal raw materials testing specifications, specifically for non-compendial raw materials
Assess test methods being used by CDMOs for non-compendial raw materials to ensure they meet industry expectations for method verification and/or validation
Perform change control activities to ensure internal raw material specifications are updated and communicated to impacted test sites
Review and assess impact of vendor change notifications related to GMP raw materials; partner with internal and external stakeholders to development plans for material changes with major impact
Provide general analytical support to DS, DP, and MSAT teams in conjunction with QC Analytical Sciences on coordination and execution of in-process analytical testing; may include review of manufacturing-related sampling/testing plans, supporting materials and process-related risk assessments, (e.g., extractables/leachables, nitrosamines, etc.), sample shipment coordination, and analytical data review and management
Interface with internal and external stakeholders to support manufacturing campaigns at CDMOs, including supporting requests for information, document review, and audits/regulatory inspections as required
Support deviations, OOS/OOT/OOE investigations, and CAPAs related to GMP raw materials and in-process testing
Qualification
Required
Deep technical expertise and understanding of GMP raw materials QC testing management and regulatory expectations
Competent and experienced operating in GMP quality management systems
Experience with analytical in-process testing for biologics (e.g., protein concentration, titer, etc.)
Author internal raw materials testing specifications, specifically for non-compendial raw materials
Assess test methods being used by CDMOs for non-compendial raw materials to ensure they meet industry expectations for method verification and/or validation
Perform change control activities to ensure internal raw material specifications are updated and communicated to impacted test sites
Review and assess impact of vendor change notifications related to GMP raw materials; partner with internal and external stakeholders to development plans for material changes with major impact
Provide general analytical support to DS, DP, and MSAT teams in conjunction with QC Analytical Sciences on coordination and execution of in-process analytical testing; may include review of manufacturing-related sampling/testing plans, supporting materials and process-related risk assessments, (e.g., extractables/leachables, nitrosamines, etc.), sample shipment coordination, and analytical data review and management
Interface with internal and external stakeholders to support manufacturing campaigns at CDMOs, including supporting requests for information, document review, and audits/regulatory inspections as required
Support deviations, OOS/OOT/OOE investigations, and CAPAs related to GMP raw materials and in-process testing
Preferred
BS or advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, etc.)
10+ years of biotech industry experience in QC operations or analytical support roles with at least 6 years demonstrated experience supporting a GMP raw materials testing program
Understanding of analytical techniques relevant to monoclonal antibody testing
Experience in relationship management with external analytical test sites
Ability to effectively prioritize and manage multiple projects
Understanding of quality systems, cGMP regulations, and industry standards applicable to biopharmaceutical manufacturing and testing
Excellent communication skills; able to collaborate effectively across multidisciplinary teams
Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless
Benefits
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Company
Apogee Therapeutics
Apogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders.
201-500 employees
H1B Sponsorship
Apogee Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
Funding
Current Stage
Public CompanyTotal Funding
$997M2025-10-08Post Ipo Equity· $345M
2024-03-07Post Ipo Equity· $483M
2023-07-13IPO
Leadership Team
Nimish Shah
Co-Founder & Board Director
Jane Pritchett Henderson
Chief Financial Officer
Recent News
2026-01-22
2026-01-06
Company data provided by crunchbase