Operations Leader - Deeside
Naynesh Mistry is currently recruiting for an Operations Technical Transfer Leader to join a growing Biopharmaceutical company based in Deeside on a permanent basis. Our client develop processes for the conjugation, purification and formulation of antibody drug conjugates.
They are entering an exciting period of growth and moving from R&D to clinical development and manufacturing. The individual must therefore be seeking a challenging, evolving and changing role.
Due to the continued growth, our client will be relocating to a new cGMP facility in Deeside mid 2018 and this role will be located in the new facility. On offer is an competitive salary (£40,000 - £45,000 - depending on experience and Pension.
To lead, manage and implement projects into the GMP manufacturing suite that have been developed by the Process Development Team for external clients. Projects will be based on the small-scale manufacture of various antibody drug conjugates and associated purification steps for clinical trial submission. You will also provide manufacturing capability, training and deliver improvements in capacity, supply, quality and compliance.
Responsibilities will include: New Product/Project Introduction:
- Manage all aspects of a new product or project introduction into the GMP manufacturing suite
- Responsible for managing a team of 3 to 6 Operations Process Technicians.
- Lead all aspects of the day to day running of the GMP manufacturing suite.
Planning & Ways of Working:
- Develop manufacturing plans for the day to day activities to be executed within the GMP suite activities and the manufacturing process steps for each project entering into the GMP manufacturing suite
Travel / Location
- May require some travel from time to time to clients or to equipment vendors.
- The main work place location will be at Deeside, though there may be some travel to the site based in Denbighshire required as this is where the Process Development team are currently situated (till the move to Deeside).
- Generally working hours will be 8:00 to 16:30 hrs but occasional overtime may be needed if the manufacturing process requires it.
Qualifications, skills and experiences:
- Degree or equivalent in a relevant subject (Science or Engineering) desirable
- Hands-on experience in GMP manufacturing in the Pharmaceutical/ Biotechnology industry.
- Experience in containment processing, either handling biologicals, toxins or cytotoxic materials.
- Strong working background in an appropriate technical environment.
- Experience in change management processes
- Experience in deviation management and root cause analysis tools
DESIRABLE:- Experience in manufacturing or developing anitbody drug conjugates.
- Use of single use systems.
- Column chromatography experience.
- Filtration experience.
- Tangential Flow Filtration experience.
For more information or to apply for this position, please contact Naynesh Mistry on 01246 457700 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH41584 in all correspondence.