Director, Head of Quality Control

Location Raleigh
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: On application
Contact name: Caroline Webster

Contact email: caroline.webster@rbwconsulting.com
Contact phone: 16179821238
Job ref: 21409
Published: about 1 month ago
Expiry date: 06 May 2021

Client: Clinical stage, cell therapy biotech

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

Type: Full-time, permanent

The Company:

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.

The role:

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.

Responsibilities:

  • 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

Required qualifications:

  • 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

Salary: On application