Job Reference: J5630606
Updated On: 07/12/2018
Status: Open to Applications
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Role OverviewWe are currently looking for a VP of Manufacturing to join a leading Therapeutics company based in the Hertfordshire area. As the VP of Manufacturing you will be responsible for establishing the Phase 1 and Phase 2 operations of a new site including the buildout of the facility, hiring and leading a team from the ground up, with the ultimate focus on manufacture genetically engineered T cell products (CAR T-Cells). You will be part of our client's global senior leadership team.
Key Duties and ResponsibilitiesYour duties as the VP of Manufacturing will be varied however the key duties and responsibilities are as follows:
1. Ensuring successful cGMP manufacturing of CAR T-cell products as part of Phase I/II clinical trials are established. You will plan, manage and coordinate activities related to the buildout of the manufacturing site (ordering equipment, supplies and oversight of qualification of cGMP suites). To do so you will need to build and develop a multi skilled manufacturing team as well as developing and managing technology transfer processes and process qualification runs.
2. . You will be part of the global Senior Leadership team and as such support the company strategy by setting business wide objectives and delivering through your site by establishing department objectives and goals. You will track and report productivity, and drive continuous Quality Improvement efforts, while working closely with all operations support functions (e.g., Quality Assurance, Quality Control, Facilities, Process Development, Project Management) to ensure that objectives are met on schedule
3. As the VP of Manufacturing you will oversee the implementation of manufacturing process development as needed for continuous quality improvement, identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients and direct logistical planning for import and export of materials.
4. You will possess a strong working knowledge of the regulatory compliance requirements for the production of biologics according to current Good Manufacturing Practices (cGMP) guidelines. Ensure staff are working in full compliance with applicable regulatory standards (e.g., cGMP) and applicable health and safety regulations and ensure all production equipment is properly working and production processes meet quality standards for cGMP compliance.
Role RequirementsTo be successful in your application to this exciting opportunity as the VP of Manufacturing we are looking to identify the following on your profile and past history:
1. Relevant degree, preferably PhD, in a relevant life sciences discipline (Immunology, Cell Biology, Bioengineering etc.) with proven leadership experience in a GMP manufacturing environment for therapeutic product (ATMPs, Mammalian Antibodies, Vaccines etc). Such experience is expected to be from an executive and senior influencing position.
2. Proven industry experience with ATMP, T-Cells, CAR T-Cells, TCR process development will be advantageous to your application however those in a Manufacturing leadership capacity putting in place new processes, activities is essential to your application under GMP standards will be prioritised.
Key Words: Vice President / VP of Manufaturing / ATMP / T Cells / Therapeutics / Manufacturing Director / Head of Manufacturing / Site Director / Gene Therapy / Process Development / Immuno-therapy / T-Cell production / Immuno-Oncology / Production Director / GMP Production Director / Manufacturing Lead / Site Director
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