Sterling Pharma Solutions - Head of Production
- Job Title:
- Head of Production
- Category:
- Technical roles
- Closing Date:
- 02/03/2025
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, materials, systems, qualifications etc.
- Management of safe systems of work.
- 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.
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