A fantastic opportunity has become available for a Manufacturing Manager to join a leading pharmaceutical business based in the Bridgend area. As the Manufacturing Manager you will be responsible for establishing a new GMP Aseptic Manufacturing function in a new facility including the recruitment and training of the team, creation of all relevant GMP documentation and establishing the smooth operation of the production process, for the manufacture of GMP clinical batches and full scale production for commercially licensed product.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Manufacturing Manager will be varied however the key duties and responsibilities are as follows:
1. Lead and represent the manufacturing function in the delivery of the GMP aseptic manufacturing facility, working full-time on the design, build and fit-out project. Working closely with other functions (Engineering, Quality etc) to identify and introduce new manufacturing equipment and processes to the facility.
2. Plan the production start-up in the new facility and recruit and train new team members in a timely fashion. Plan, prepare and manage the manufacturing budget. Establish and manage the production schedule to meet clinical needs and ensure that output is manufactured in accordance to cGMP and Regulatory expectations.
3. Contribute to the development and execution of the technical transfer protocol and process qualification and validation. Participate actively in the preparation for the Manufacturing and Importation Authorisation - be the named person responsible for production on the authorisation.
4. Participate in, and lead elements of inspections by Regulatory Authorities including MHRA and FDA. Ensure close-out of any deficiencies identified during those inspections that relate to the role-holder's scope of operations.
5. Champion continuous improvement in the manufacturing facility to enable production to be completed in the most effective manner.
To be successful in your application to this exciting opportunity as the Manufacturing Manager we are looking to identify the following on your profile and past history:
1. You will have a relevant degree qualification or equivalent in a scientific or engineering discipline. Experience of managing manufacturing teams is essential.
2. Proven industry experience of introducing new processes and equipment into a pharmaceutical GMP manufacturing facility and experience of leading the production team in EU and/or FDA GMP regulatory inspections.
3. Previous experience of manufacturing products within a aseptic or sterile environment, and/or demonstrate the capability of learning the relevant processes. Experience of establishing a new GMP manufacturing unit is desirable.
Key Words: Pharmaceutical | Production | Manufacturing | Aseptic | Sterile | Management | GMP
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals 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
- Posted: 10th October 2017
- Expires: 7th November 2017
- Reference: J4568