Associate Director, QC Manufacturing Support

We are seeking an Associate Director, QC Manufacturing Support to provide GMP raw materials testing program management and to additionally support drug substance process-related analytical testing activities as a liaison to Apogee’s DS, DP, and MSAT teams. The ideal candidate has deep technical expertise and understanding of GMP raw materials QC testing management and regulatory expectations, is competent and experienced operating in GMP quality management systems and has experience with analytical in-process testing for biologics (e.g., protein concentration, titer, etc.).

Responsibilities may include:

• 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 Qualifications:

• 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

The anticipated salary range for candidates for this role will be $160,000-$180,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.