Associate Director, QC Manufacturing Support
Apogee Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $160,000 - $180,000 per year
Job Level
About the role
- 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
Requirements
- 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
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical chemistrybiochemistryGMP raw materials testinganalytical techniquesin-process analytical testingrisk assessmentschange controldeviations investigationsOOS investigationsCAPAs
Soft Skills
relationship managementproject managementcommunicationcollaborationprioritizationstakeholder engagementteamworkproblem-solvingadaptabilityleadership