Validation Lead

Hobson Prior are looking for a Validation Lead to join a biopharmaceutical company to join them on a permanent basis in Stevenage. Our client is focused on developing specific therapies that tackle the immune system to destroy cancer cells.

Job Responsibilities:

• Working part of the leadership team, you will be accountable for the setup of the organisation's manufacturing footprint, ensuring successful delivery of technology transfer, process validation, equipment validation and qualification, and materials management to meet project timelines.
• Assist in leading the manufacturing function in interactions across all relevant internal stakeholders covering maintenance, facilities, Quality Assurance, production and supply chain to ensure compliant delivery of validation.
• Develop project validation plans, risk assessments, qualification protocols and reports for ensuring effective tech transfer of manufacturing process and continued maintenance of the validation master plan.
• Accountable to assist in the preparation and review of GMP documentation including SOPs, change controls, user requirement specifications, process deviations, and risk assessments to ensure the highest levels of controls and traceability.
• Support Bio process engineering and validation activity through integration of new closed system technology and procedures in accordance with GMP and regulatory standards.
• Work in co-operation with the Production team to ensure effective delivery of clinical development plan.
• To interact with external parties supplying processing equipment and assess equipment in scope of GMP compliance.
• Ensure continued maintenance of GMP cleanroom environment suitable for the manufacture of ATMPs.

Key Skills:

• Strongly focused on quality and safety.
• Robust planning and organisational and time management skills.
• Have excellent communication and interpersonal skills
• Self-motivated with strong initiative and drive.

Requirements:

• BSC/MSC in a Biological Science discipline.
• At least 10 years' experience in a scientific laboratory role.
• At least 5 years' experience working in a regulated environment (GLP/GCLP/GMP).
• Experience in human cell isolation, and cell and tissue culture in a GMP compliant environment.
• Experience of Grade D, C and B cleanrooms and isolator technology for the manufacture of Advanced Therapies.
• ATMP Process validation experience.
• Understanding of GMP, ATMP, and EUTCD regulations.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.