Reference Number: JO-2201-484970
QC Director/Associate Director
Job Type: Permanent
Job Title: QC Director / Associate Director
Location: Oxford, UK
Salary: Attractive salary + Benefits
** Please read **
The following requirements are essential for this position
- Full right to work in the UK
- MSc or PhD in Analytical sciences, Biological science, or related discipline
- Experience in Quality Control, Quality Management Systems, GMP QC Operation Systems and GMP Regulatory requirements within the biopharmaceutical industry (preferable biologics, vaccines, cell/gene therapy products).
Would you like to work for a multinational biotech? CPL Life Sciences is collaborating with a global biotech that is specialized in the development of new generation immunotherapies designed to treat cancer, infections and autoimmune diseases! They are looking for an Associate Director with broad experience in QC functions and operations.
MAIN PURPOSE OF ROLE:
The focus of this role will be the strategic development and implementation of the QC function of the company. The successful candidate will be required to support the manufacturing of stable drug substances and drug products to GMP standards in regards to shelf life, in a presentation suitable for administration to patients. Additionally, this role requires strong leadership skills to support and guide a team of QC stability scientists who will be responsible for the QC data presentation within regulatory submissions to EU and US regulatory authorities.
PRINCIPAL DUTIES AND RESPONSIBILITIES
- Development of specifications and testing protocols.
- QC/stability operations development and management.
- Training, coaching, and mentoring of QC team members.
- Support QC manufacturing activities for internal batch productions.
- Input within the CMC leadership team in regards to drug delivery programmes.
- Oversight of technology transfer of GMP QC tests between labs (external or internal).
- Team management, coordination and compliance based on health and safety policies.
- Coordination of release testing, stability programs, and regulatory shelf-life strategies.
- Contribution into the relevant stability information included EU & US regulatory submissions.
- Administration of outsourced programmes by providing scientific scrutiny and interpretation, ensuring robust quality deliverables.
- Handling of packages and transfers of analytical method validation, ensuring compliance with relevant specifications, standards, and processes, ensuring data integrity.
EXPERIENCE AND KNOWELDGE
Essential Experience of:
- Line management
- Auditing 3rd parties
- Analytical validation and technology transfer
- QC stability design and Product shelf-life
- Late-stage, BLA/MAA filings and associated regulatory requirements, and regulatory authoring.
Desire Experience of:
- Molecular modelling.
- Experiment design (DoE).
- Finance and budget control.
- Presentation of Scientific findings.
If you are looking for an opportunity to enhance your experience, broaden your career horizons and change the future apply today. For more information book a call through Georgia.Mouzouridou@cpl.com