Senior Manager, QC Raw Materials

2 weeks ago

Waltham, United States ElevateBio Full time

The Role:

The Senior Manager, Quality Control will work cross-functionally with Technical Operations/ Manufacturing Sciences & Technology, Manufacturing, Supply Chain, Quality Control and Quality Assurance to implement and manage the Raw Material Program at our Waltham Base Camp facility. Specifically, this position will work to establish control strategies, specifications and testing & inspection procedures for raw materials used to manufacture clinical-stage gene and cell therapy products.

Here’s What You’ll Do:

Manage and develop the team responsible for the Quality Control Raw Materials program, the QC Raw Materials Testing Laboratory and outsourced raw material testing labs.

Serve as the business system owner for the Quality Control Raw Materials program, including:

Raw Material risk assessments

Raw Material specifications

Inspection of Raw Materials

Release of Raw Materials

In-house testing of Raw Materials

Outsourced testing of Raw Materials

Raw Material retains

Develop and implement efficient, phase-appropriate, risk-based control strategies for raw materials using applicable GMP regulations and compendial monographs, with close interdependence to the Technology Transfer program and Supplier Quality program.

Oversee and manage routine raw material testing and release in LIMS and ERP systems.

Draft, review and approve raw material SOPs, test methods, specifications and associated protocols and reports.

Manage lifecycle of Raw Material program elements and other projects related to materials, suppliers, and service providers, in collaboration with QA, QC, Technical Operations and Manufacturing teams.

Collaborate on and oversee material/supplier-related Change Controls, CAPA, Deviations events, including Non-Conforming Material procedures and Supplier Corrective Action Requests.

Assess Supplier Change Notifications and changes to compendial monographs.

Support regulatory inspections, supplier audits, and client audits

Lead, facilitate and participate in Quality meetings, Raw Material Review Board, Supplier Review Board and Quality Management Review.

Promote a culture of Safety, Quality and GxP continuous improvement across the organization including training initiatives.

Requirements:

BS in a scientific discipline with 8 years’ experience in pharmaceutical / biotech industry within Quality Control or Quality Assurance, at least 4 years managing QC Testing Laboratory

Experience with raw material testing programs and methodologies (FT-IR, Raman, NIR, Dot-blot, ELISA, and HPLC)

Ability to communicate and work independently with scientific/technical personnel.

Strong knowledge of GMPs, SOPs, and Quality system processes.

Excellent organizational skills.

Experience in cell and gene therapy manufacturing environment a plus

Experience performing laboratory investigations, including out of specification investigations

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