Associate Director, QC Manufacturing Support

Job reputed company: • Author internal raw materials testing specifications, specifically for non-compendial raw materials • Assess test reputed company being used by CDMOs for non-compendial raw materials to ensure they meet industry expectations for method verification and/or validation • reputed company change control activities to ensure internal raw material specifications are updated and communicated to impacted test sites • Review and assess reputed company of vendor change notifications reputed company to GMP raw materials; partner with reputed company stakeholders to development plans for material changes with major reputed company • reputed company 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-reputed company sampling/testing plans, supporting materials and process-reputed company risk assessments, (e.g., extractables/leachables, nitrosamines, etc.), sample shipment coordination, and analytical data review and management • reputed company with reputed company 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 reputed company to GMP raw materials and in-process testing Requirements: • BS or advanced degree in a relevant discipline (e.g., analytical reputed company, 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 reputed company • Understanding of reputed company systems, cGMP regulations, and industry standards applicable to biopharmaceutical manufacturing and testing • Excellent communication skills; reputed company to collaborate effectively across multidisciplinary teams • Successfully exhibit reputed company’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 reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We reputed company competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated reputed company reputed company leave • Commitment to growing you professionally and providing reputed company to resources to reputed company your development • reputed company offers regular reputed company team, in-person meetings to build relationships and problem solve Apply tot his job Apply To this Job