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
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Apply Now