Senior Manager, Quality Control Raw Materials

Position Overview:

The QC Manager, Raw Materials will be responsible for developing, leading, and managing the Raw Materials QC program at the Beam Therapeutics Manufacturing facility in Durham, NC. This role will develop and maintain documentation regarding testing requirements and strategies, serve as a subject matter expert (SME) for raw materials issues, providing technical expertise aligned with current GMPs and current industry practices. This person will have knowledge and experience with USP methods, and the ability to apply as required, and as well as maintaining compliance to USP, ICH and FDA guidance documents. Interface with Manufacturing, Supply Chain, and Quality Assurance leadership and participate and/or lead interdepartmental teams to address quality-related issues.

This role requires on-site presence and engagement. The position will report to the Quality Control Senior Director.

Primary Responsibilities:

• Build and manage the raw materials QC program at the Beam Therapeutics Manufacturing facility.
• Develop and maintain all documentation with regards to testing requirements and strategies, including material specifications.
• Serve as a SME for raw materials issues, providing technical expertise aligned with current GMPs and current industry best practices.
• Manage contract laboratories as needed.
• Own and author risk assessments for raw material programs.
• Support supplier change notifications and material enrollment.
• Identify need for development of new assays with compendial and GxP requirements.
• Accountable for managing the raw materials testing program to ensure quality, product specifications and adherence to all current GMPs, USP, ICH and FDA guidance documents.
• Evaluate QC systems and recommend and/or implement system improvements.
• Author technical protocols and reports for Raw Materials testing qualification, validation, or verification.
• Author test methods and SOPs for the Raw Materials testing program.
• Create, review, and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls.
• Manages release of raw materials used in manufacturing.
• Provide oversight of material master data as it relates to inspection plans and material life cycle.
• Maintain records and databases in accordance with procedures.
• Hire and manage staff as needed.
• Oversee management of in-house raw material test equipment.

Qualifications:

• Bachelor’s or advanced degree in biology, biochemistry or closely related scientific discipline.
• At least 7-10 years of CGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
• Expert knowledge of pharmaceutical/biotech Raw Materials testing is required.
• At least 3 years of management experience is required.
• Basic knowledge of qualifications and validations; current industry practices; and strong experience with guidance interpretation and application.
• Knowledge of cGMPs, ICH, USP, FDA requirements is required, including equipment and method validation/verification.
• Experience with risk assessment tools is desired
• Excellent critical thinking and technical writing skills.
• Excellent interpersonal and communication skills to lead, facilitate and follow.
• Computer skills required to use Microsoft Word, Project, Visio, and Excel programs.