Summary of the Production Supervisor role

As the Production Supervisor you will be responsible for leading cGMP processes and a team of Manufacturing Technicians for a range of bioconjugates, and more specifically Antibody Drug Conjugates.

This is an exciting opportunity to work in a small team initially with planned future strategic expansion. Working across departments, the Production Supervisor will lead and develop a core team for the manufacturing of complex ADCs. You will coordinate the safe day to day operations and administration of the manufacturing area to meet quality, safety, delivery and client requirements. This role will be key to achieving delivery and compliance of client projects.

Sterling's facility in Deeside site can be found lying alongside the waterways of the River Dee, presenting a quintessential glimpse of life in North Wales, with numerous nature parks, shopping centres and rural villages, providing plenty of opportunities to get out and explore. It's just a short journey from the cities of Chester, Liverpool and Manchester or you can choose to go a little further afield and from the mountains of Snowdonia to the all Wales coastal path, walking is a dream in North Wales.

Relocation would be supported for the right candidate.

Who Are We?

We are a fast-growing global pharmaceutical CDMO (Contract Development and Manufacturing Organisation), with more than 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). We are a proven and trusted partner to some of the world's most innovative biotechs and leading pharmaceutical companies and are widely recognised for our expertise in complex and hazardous chemistry.

We are a dynamic business, employing more than 1300 talented and passionate people in the UK, US and Europe who together support our customers in bringing new medicines to market, improving and saving the lives of patients. We support our customers through the full product lifecycle from pre-clinical development right up to full scale commercial manufacturing and today we are proud to have built a culture of excellence in science and unrivalled service.

Our Sterling facility at Deeside focus on antibody, protein and peptide drug conjugate medicines and technology. Antibody Drug Conjugate combine the cell and tissue specificity of monoclonal antibodies with the cell killing potential of highly potent small molecules and represent one of the fastest growing sectors in the oncology field.

Your responsibilities

• Managing and leading a team of Manufacturing Technicians to deliver client GMP production campaigns.
• Ensuring that all manufacturing staff are suitably trained to support production operations.
• Scheduling day to day production operations.
• Introducing and the qualifying of new equipment and ongoing requalification.
• Supporting the technical transfer from internal and external customers to establish production processes.
• Ensuring the completion of production documentation including but not limited to batch manufacturing records, equipment logbooks and batch reports.
• Generating production documentation including but not limited to batch manufacturing records and department standard operating procedures.
• Ensuring the completion of production documentation including but not limited to batch manufacturing records, equipment logbooks and batch reports.
• Generating production documentation including but not limited to batch manufacturing records and department standard operating procedures.
• Supporting the delivery of the teams Quality Management System KPIs for deviations, change control, CAPAs and periodic documentation reviews.
• Providing training to the team and supporting staff in the production of client GMP campaigns.
• Responsibility for the safety of your direct reports.
• Contributing to new business development activities as required including: -
  • Requests for information.
  • Proposal writing.
  • Audits.
  • Technical meetings.
• Embodying our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.

Requirements for the role

• Previous experience of working in cGMP biologics manufacturing, ideally ADCs in a CDMO environment.
• Strong knowledge of GMP manufacturing of biologics bulk drug substances.
• Working knowledge of drug fill finish would be advantageous.
• Team management and supervisory experience would be advantageous but not essential.
• Experienced in protein downstream unit operations and at minimum have hands on experience of:
  • Tangential Flow Filtration - set up, maintenance and operation.
  • Chromatography - column packing, testing and chromatographic process operation.
  • Product filtration.
  • Process solution preparation, filtration and storage.
• Experience with aseptic procedures, systems and equipment.
• Experience working under GMP Quality Management System.
• Highly organised person with demonstrated capability in planning and or project management, planning execution of teams, materials, systems, qualifications etc.
• Has a safety first, right first time, and customer orientated mindset.
• Must align to our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.

Why Consider Us?

Our collaborative and empowering culture is unique to us and is what really sets us apart as a business and this is built upon our four core values: Be Transparent, Be Reliable, Be Willing and Be Caring. We also run a variety of programmes across our sites to promote health, wellbeing and work life balance, in addition to supporting causes and charities close to our employees' hearts, encouraging volunteering within the communities we are part of and even arranging socials, through our global social committees, to encourage team building and reward our team's hard work.

At Sterling we promote mutual trust and respect regardless of your nationality, background, feelings, beliefs, gender or age. Our workforce, much like life, is made up of many different people with many different backgrounds, needs and perspectives. This is something we celebrate at Sterling, as it makes Sterling a better place to work and encourages innovation and collaboration.

We offer a competitive compensation and benefits package including bonus, pension scheme, private healthcare, Engagement Hub, cycle to work scheme, death in service coverage, on-site health and wellbeing support including medical consultations and physiotherapy, 24/7 employee assistance programme, employee referral scheme, sports and social club as well as opportunity for training and further career development.