Director, Head of Quality Control

Client: Clinical stage, cell therapy biotech

Location: Raleigh, NC (this is an on-site position)

Type: Full-time, permanent

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The Company:

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We have partnered with a fast-growing cell therapy biotech, focussed on pioneering a first of it's kind gene-edited CAR T-cells to treat cancer patients. This global biotech is headquartered in the EU, with a US headquarters in New York and a brand new GMP manufacturing facility in Raleigh, NC. This is a unique opportunity to join a clinical-stage biopharmaceutical company with over 21 years of expertise in gene editing at a critical point in their growth as they expand their footprint in the US.

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The role:

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We are seeking a highly qualified Director of Quality Control to lead the QC function at a brand new, state of the art cell therapy GMP facility. Reporting to the VP of Quality Assurance, this is an exciting opportunity for a highly skilled Quality leader to build and develop an exceptional team of QC professionals within a fast-growing biotech. The successful candidate will play a key leadership role by designing and implementing labs at the new manufacturing facility.

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Responsibilities:

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• Oversee Method Development, Qualification and Validation for GMP facility

• Manage routine testing and generation of Certificate of Analysis Developing functional capabilities within the department to keep pace with advances in technology and company growth

• Develop and coordinate the Quality Control laboratory activities and capabilities to provide timely, accurate and cGMP compliant testing of raw materials, in-process materials, final product and contract manufactured materials

• Build strong working relationships with Manufacturing, Quality Assurance and MSAT to achieve company objectives

• Collaborate with MSAT and/or outside contract labs to ensure seamless method validation and transfer

• Ensure that any internal and external laboratories comply with GMP standards

• Serve as a Subject Matter Expert (SME) to provide input on timeliness and to address analytical/microbiological related issues

• Recruit, train and oversee an exceptional team of QC lab analysts and specialists

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Required qualifications:

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• Bachelor's degree in Chemistry, Biology or related discipline required; higher degree preferred

• 12+ years experience in the biopharmaceutical industry

• 8+ years direct experience in leading, overseeing, implementing or supporting Quality Control laboratory teams

• Comprehensive knowledge of compliance with cGMP regulations

• Understanding of laboratory equipment such as qPCR, Flow Cytometer, UV/Vis Spectrophotometer, Densitometer, Gel Imager, pH, Osmometer, etc

• Comprehensive knowledge of biological and microbial analysis, manufacturing operations, GMP's and the theories and general principles behind them

• Prior cell and/or gene therapy experience a plus

• Excellent communication and cross functional collaboration skills

• Hands-on leadership ability and desire to motivate and drive teams to success

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Salary: On application