Associate Director, QC Manufacturing Support

Job Description: • 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: • A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • 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 • Apogee offers regular all team, in-person meetings to build relationships and problem solve Apply tot his job