Why work for this company?
Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services.
- 65+ years of experience in health
- Nearly $6 billion annual revenues
- 25 manufacturing sites around the world
- 10,000 employees worldwide of which 1,100 employees are committed to R&D
This role within the Manufacturing Department is responsible for providing technical services within the manufacturing team. The person is responsible for building a team to support tech transfer of production processes for recombinant antibodies for veterinary use. This role leads manufacturing support and all aspects to do with validation including process and cleaning validation. This role will involve highly collaborative interaction with other stakeholders to plan projects and timelines and coordinate activities.
- Role that this position reports to: Director – Manufacturing
- Role/s that may report to this position: Process Scientist, Process Technologist, Analytical Scientists, Validation Engineers
Duties & Responsibilities
- Lead process validation programme, including viral validation studies, cleaning validation.
- Responsible for production equipment qualification prior to handover to sustaining phase.
- Lead tech transfer of products from sister sites, having appropriate procedures in place.
- Lead writing of relevant sections of CTD to support regulatory submissions.
- Manage Change Control for process changes.
- Technical lead for process related risk assessment.
- Provides manufacturing support (investigations, change controls, CAPAs, process capability/capacity/efficiency/quality improvements)
- Manage Extractables and Leachables program.
- Identify continuous improvement initiatives, action plans to implement operational excellence, lean practices along with setting and maintaining department goals and metrics.
- Active member of the site leadership team developing and implementing appropriate strategies and aligning employees to these strategies.
- Project management and scheduling activities to ensure adherence to overall project schedule.
- Work independently to meet key deliverables and milestones in addition to being able to effectively lead a matrix team.
- Provides timely and thorough project updates and ensures compliance with GMP and safety requirements.
- PhD, MSC in a relevant discipline (e.g biochemistry, chemistry, process engineering) or equivalent experience.
- At least 10 years relevant experience in bioprocess development and/or commercial manufacturing, process scale up and process validation.
- Experience with large scale manufacturing support for mammalian cell culture, bioreactors, downstream processing, liquid media manufacturing (vials, bags, bottles), Single Use Systems, current Good Manufacturing Practices and US / EU regulations.
- Strong leadership skills; strong communication, technical writing, organisational and interpersonal skills.
- Knowledge should include a combination of cell biology, cell culture, scale up and mass transfer, media/buffer tank operation, virus/sterile filtration and aseptic processing technologies.
- Demonstrates critical thinking skills in problem solving and decision making.
Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003