Assoc Director Upstream Manufacturing

Hrm

Louth

This leading global biologics organisation provides and offers comprehensive integrated and customisable services to the Bio-pharmaceutical and related industry sectors from contract development services right through to contract manufacturing services to some of the largest biopharma and pharma organisations globally. Recently, this business has announced expansions into geographies such as the U.S and most recently Ireland where a significant investment has been undertaken to build a new cell culture green-field manufacturing site which once builds, will be the largest single use biologics manufacturing plant globally. This site has been designed to run continuous bio-processing, a next-generation manufacturing technology which will be implemented for the first time at this site and once complete will employ in the region of 400 staff. With this expansion, an exciting opportunity has arisen for an Upstream/Cell Culture professional/leader to join the organisation at the start-up phase in leading this business through construction and into manufacturing. The Role: The candidate will lead a group of Upstream professionals in the commercial Upstream processing area. The individual will perform analysis of historical data to support process scale-up across facilities in commercial manufacturing. This will include troubleshooting observed process differences as well as driving and improving current scaling techniques and tools. The position will also entail vessel characterisation, hands-on cell culture fermentation at commercial scale along with the associated experimental planning, coordination, and report writing. The position needs to have experience in leading a team, a goal-oriented mindset, and a can-do attitude. The position will work with QA, QC, Engineering, Supply Chain Planning, PD, Regulatory, Logistics, Project Management and Strategic Sourcing/Procurement. The Person: B.Sc, MS or PhD in Chemical Engineering, Bioscience, or Biotechnology. >8-10 years in biopharmaceutical manufacturing with extensive experience in upstream processing. The ideal candidate will have proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant. Expertise and specific experiences modelling bio-reactors, applying oxygen mass transfer, power per volume, carbon dioxide stripping models, vessel mixing characterisation, eddy size application, hydrodynamic shear, etc. is preferred. The candidate should have a strong background in cellular metabolism, various mammalian cell lines, and be scientifically minded. Hands-on experience with various size bioreactors (both single use bioreactor (SUB) and traditional SS tank) and applying the previously mentioned techniques across those scales is desired. The individual need to have good understanding in DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification. The candidate must have experience in dealing with FDA, and/or EMA and CFDA, and have a solid understanding of the quality system in terms of deviation, investigation, CAPA and change control. The individual should have experience in CIP, SIP, clean room and water system (Purified Water, pure steam, and WFI. The candidate must have the following attributes: Can do attitude, good organisational skill, attention to details, strong communication skill, team-oriented, leadership skill and work well with people. To discover more about this opportunity, apply now or contact Shane Browne at HRM on 353 1 6321827 for a confidential discussion. This job originally appeared on RecruitIreland.com.

2056 days ago