Head of Production

6 months ago

Deeside, United Kingdom Sterling Pharma Solutions Full time

**Summary of the Head of Production role**

As the Head of Production, you will report directly to the Site Lead based at our facility in Deeside, North Wales. This is an exciting growth opportunity to work within a small team initially, with plans for future strategic expansion and is a key role to achieving operational readiness and compliance for our manufacturing facility at Deeside.

You will work across departments to establish the operational procedures and develop a core team for the manufacturing of complex biologics. You will coordinate the safe day to day operations and administrations of the manufacturing and warehouse area to meet quality, safety, budget, scheduling and client requirements and have responsibility for a team of GMP Technicians and Warehouse Supervisor.

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.

**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.

**Your responsibilities**
- Supervising, controlling and ensuring safety and quality compliance within the manufacturing areas.
- Ensuring routine operational compliance checks are carried out within the manufacturing area, e.g. process equipment status, status labelling, line clearance, segregation, cleaning, process and room monitoring.
- Developing templates for batch manufacturing records (BMRs) and managing the generation of those in a timely manner for client and internal review and approval.
- Determining equipment and material requirements for new business proposals.
- Working as part of a team to design, install and quality equipment for the manufacture of clinical bioconjugates materials and products.
- Ensuring compliance via in-process monitoring including process sampling.
- Overseeing receipt, transport and storage of materials within the manufacturing area.
- Providing manufacturing support and input to regulatory agency inspections.
- Reviewing documentation (batch records, SOPs) for completeness, clarity, accuracy and submitting edits to documents for revision.
- Working closely with Technical Services to ensure effective integration of tech-transfer and NPI.
- Ensuring manufacturing compliance to all regulatory requirements - GMP, FDA etc.
- Checking the maintenance status of the department, premises and equipment including operational maintenance of clean rooms.
- Ensuring the appropriate validations are done.
- Working closely with QA, raising and investigating deviations, root cause analysis, writing reports and closing out related corrective action preventative action (CAPAs).
- Embodying our company values; **Be Transparent, Be Willing, Be Reliable and Be Caring.**

**Requirements for the role**
- Previous experience of working in a cGMP biologics manufacturing, ideally in a CDMO environment.
- Degree educated in a science or engineering discipline, or equivalent experience from pharmaceutical / life sciences background.
- Strong knowledge of GMP manufacturing of biologics bulk drug substances.
- Team management and supervisory experience.
- Experienced in protein downstream unit operations:

- Tangential Flow Filtration - set up, maintenance and operation.
- Chromatography - column packing, testing and chromatographic process operation.
- Production filtration.
- Process solution preparation, filtration, and storage.
- Experience with aseptic procedures, systems, and equipment.
- Experience in developing and growing strong relationships throughout the supply chain.
- Experience of preparing systems, facilities and training for customer and regulatory inspections and presenting as part of these inspections.
- Highly organised with demonstrated capability in planning and or project management, planning executions of teams, ma

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