Naynesh Mistry at CK Science is currently recruiting for a Sterile Team Leader (Sterile Manufacturing) 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, relocation assistance and additional benefits.
Experience of Sterile vial filling is essential and working with isolator technology would be a bonus.
- To co-ordinate and lead the activities of the Vial Manufacturing team in a safe and cGMP/regulatory compliant manner.
- To assist in establishing and then coordinate and lead the Vial Manufacturing team in such a way that as both individuals and as a team, they are engaged, motivated, enabled and empowered to achieve the Vial manufacturing schedule.
As a Team Leader you will:
· Communicate, co-ordinate and lead the activities of the Vial Manufacturing team to achieve high levels of performance and engagement, ensuring project/manufacturing expectations and targets are met or exceeded.
· 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 Team Leader (Fill Finish/Vial Manufacturing) will have the following qualifications, skills and experiences:
- BSc in biotechnology, chemistry, bio/chemical engineering or comparable preferable
· Experienced and knowledgeable in aseptic manufacturing of (in vial) biopharmaceutical products in a cGMP regulated environment.
· Proven experience of/ability to lead and manage people and their activities.
· Experience of capital projects/start-ups (including URS, FAT, SAT, IQ, OQ, PQ ) would be beneficial.
· An overall knowledge and understanding of the regulatory landscape for aseptic drug product manufacture and experience of participating in 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.
Personal & Leadership Qualities:
· Leads with humility and even good humour: capable of acknowledging own mistakes and learning opportunities. Inspires this behaviour in others.
· Able to challenge the status quo in a constructive and collaborative manner.
- Shows respect and understanding for diversity of views and opinions, no matter to whom they belong, whilst being unafraid to take the hard conversations.
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 SH40346 in all correspondence.
You MUST be eligible to work in Iceland. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 11th October 2017
- Expires: 8th November 2017
- Reference: SH40346