We are currently looking for a Manufacturing Director to join a leading Therapeutics company based in the Hertfordshire area. As the Manufacturing Director you will be responsible for establishing the Phase 1 and Phase 2 operations 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.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Manufacturing Director 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 establish department objectives and goals, 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 Manufacturing Director 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.
To be successful in your application to this exciting opportunity as the Manufacturing Director 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 experience in a therapeutic environment leading process development activities.
2. Proven industry experience with ATMP, T-Cells, CAR T-Cells, TCR process development in a leadership capacity putting in place new processes, activities is essential to your application.
3. Those with experience working in a GMP regulated environment will take priority on application.
Key Words: ATMP / T Cells / Therapeutics / Manufacturing Director / Head of Manufacturing / Site Director / Gene Therapy / Process Development / Immuno-therapy / T-Cell production / Immuno-Oncology
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Ricky Martin
- Phone: 0203 910 2980
- Reference: J5630606
- Posted: 7th December 2018
- Expires: 4th January 2019