Naynesh Mistry is currently recruiting for a Manufacturing Upstream Team Leader to join a leading Biopharmaceutical company based in Iceland on a permanent basis. The company is dedicated to becoming one of the leaders in the biosimilar monoclonal antibody market. The company offers a generous salary package (in excess of £70,000), relocation assistance and additional benefits.
- To co-ordinate and lead the activities of the API USP team in a safe and cGMP/regulatory compliant manner.
- To assist in establishing and then coordinate and lead the API USP Manufacturing team in such a way that as both individuals and as a team, they are engaged, motivated, enabled and empowered to achieve the Upstream manufacturing schedule.
As a Manufacturing Upstream Team Leader you will:
· Communicate, co-ordinate and lead the activities of the Upstream API team to achieve high levels of performance and engagement, ensuring project/manufacturing expectations and targets are met or exceeded.
· Contribute to the Technical Transfer from CMO's and thereafter, the process development of methods for making products at the required scale and/or evaluating existing processes to identify areas for improvement.
· Lead/support/take part in Qualification and Validation activities e.g. FAT/SAT, IQ, OQ, PQ and PV as required to assist adherence to manufacturing strategy milestones.
The successful Manufacturing Upstream Team Leader will have the following qualifications, skills and experiences:
- BSc in biotechnology, chemistry, bio/chemical engineering or comparable
· Solid scientific and manufacturing knowledge of upstream fermentation activities to aseptically generate and proliferate mammalian cell cultures (in both production and lab scale) including hands-on expertise operating equipment including Bioreactors and Shakers.
· Significant pharmaceutical experience including industry experience in biopharmaceuticals.
· Proven experience of/ability to lead and manage people and their activities.
· Practical experience of URS, FAT, SAT, IQ, OQ, PQ
· Experience of supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.
- Expertise working with up-to-date cGMP compliance and associated documentation
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH39552 in all correspondence.
You MUST be eligible to work in Iceland. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 9th August 2017
- Expires: 6th September 2017
- Reference: SH39552