Upstream Processing Lead - Fermentation - Iceland - £60k-£80k - Validation - Biopharmaceuticals - Bioreactors - Production
A growing Bio-Pharmaceutical company is at an exciting stage of expansion and require Upstream Processing expertise to continue this development. There is an opportunity for an Upstream Process Expert and Upstream Processing Team Leader to join the team. Both opportunities require significant experience in Upstream Processing and Fermentation activities.
*To set up and operate production equipment and processes in the Upstream Processing Suite to produce monoclonal antibodies and recombinant protein products in a safe and cGMP/regulatory compliant manner, to meet or exceed project and/or manufacturing expectations and targets.
Key aspects of the role
*Build, clean and sterilise equipment and prepare sterile reagents to support Media preparation, in compliance with appropriate MIR's, SOP's and Work Instructions, completing log books as appropriate.
*Aseptically generate and proliferate mammalian cell cultures by operating single-use (disposable) bioreactors (up to 2000 L) and Shakers.
*Support the maintenance of a compliant facility by, for example, WFI and environmental monitoring sampling and responding appropriately to FMS alarms.
*As a Trained Trainer, train, coach and mentor others to contribute to achieving a highly, multi-skilled and engaged USP team.
*Proactively highlight to Team Leader any issues of concern, whether they be plant, process, people or performance.
*Determine equipment requirements via User Requirement Specifications and 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.
*Author, draft, amend and review operating documents i.e. SOP's BMRs, Validation Reports, Training Packages, Material Requirement Specifications and other cGMP documentation.
*A key contributor in ensuring the USP suite and equipment is maintained in a state of Inspection readiness at all times.
*Take ownership for deviations, identifying root cause and appropriate corrective actions.
*Proactively establish collaborative, constructive and affable cross-functional working relationships as required to enable any issues arising in USP to be resolved/completed in a timely, efficient and effective manner.
*As a Subject Matter Expert, contribute to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interaction with regulatory agencies as required.
*Continually identify process improvement and waste elimination opportunities to help create and maintain a lean, flexible and agile manufacturing facility.
*Accountable for own Continuous Professional Development and to proactively share knowledge for the benefit of others.
*Enjoy the challenge of setting and achieving high levels of personal performance and goals but never at the expense of the failure of others.
Experience and Qualifications Required
*BSc in biotechnology, chemistry, bio/chemical engineering or comparable.
*Fluent command of the English language, both spoken and written
Experience and knowledge:
*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.
*Prior experience in biopharmaceuticals.
*Proven experience coaching and mentoring others.
*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.
Personal & Leadership Qualities:
*Displays 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.
*Encourages initiative, drive and the ability to understand the need for and welcome change.
*An innovative and creative thinker who can turn theoretical ideas into practical actions.
*Works and thinks in a lean and agile manner and encourages this in others.
*Is a role model for own team and others in terms of helping to create an enjoyable, high energy and inspiring work environment.
*Demonstrates a passion for success and inspires this in others.
You MUST be eligible to work in Iceland. Learn more
- Agency: Cranleigh Scientific
- Posted: 4th July 2017
- Expires: 1st August 2017
- Reference: BBBH4872