BioUETIKON is a young growing dynamic biopharmaceutical process development and cGMP contract manufacturer (CMO) based in Dublin, Ireland, operating from a facility that first produced a therapeutic r-protein substance for commercial supply in 1995. The company immediately requires an experienced qualified manager for its Cell Culture Department to provide direction, drive and operational support to upstream development and cGMP activities including clone selection, process development, cell banking, scale up, verification and cGMP production.
This is a key position and the successful candidate will be responsible for leading and expanding the Cell Culture Team. Projects include the development of novel upstream processes for the production of recombinant proteins such as antibody therapeutics, cytokines and vaccines as well as the transfer and implementation of client processes. This is an exciting opportunity for the right candidate offering a stimulating and varied environment and a chance to significantly influence the development of the business. A competitive package is available.
Duties
Development and operation of bioreactor manufacturing processes utilizing mammalian and other cell expression systems that meet GMP manufacturing requirements including batch or fed-batch cell culture processes or perfusion processes using various types of cell retention technologies in a range of bioreactors(Glass, Stainless Steel and Single Use)
- Media development and optimization studies.
- Introduction of new processes and technologies into cGMP manufacturing.
- Interaction with clients to facilitate the transfer of technical information between BioUETIKON and the client organization.
- Good understanding of regulatory compliance and guidelines (e.g. FDA, EMEA, and ICH).
- Development, planning and execution of pre-GMP scaled process runs/toxicology and clinical material.
- Establish Bill of Materials list for new processes and maintenance of laboratory inventories and equipment.
- Direction of Cell Culture Team. Manage Laboratory schedules to account for priority changes and project status. Interact with QC and Downstream Team to consolidate schedules.
- Record process development activities and results in appropriate notebooks.
- Technology transfer of upstream processes into production and the training of production personnel. Coordination of activities and the communication to assure efficient transfer of projects to manufacturing.
- Writing and executing design input protocols and design output reports.
- Writing SOPs and Batch records for newly implemented manufacturing processes.
- Good verbal and written skills to communicate project status with clients and Project Management as needed.
- Estimation of cost and assessment of technical aspects of processes for Sales and Marketing in order to develop accurate project plans.
- Interfacing with Sales and Marketing directly with perspective clients in order to facilitate sales.
Educational Experience /Requirements
- The successful candidate is likely to have seven+ years relevant biopharmaceutical industry experience (scientific and engineering) with a proven track record of accomplishments in the design, development, implementation and validation of bioreactor processes for the production of monoclonal antibody and recombinant protein therapeutic drug substance including GMP documentation.
- This position requires a BS, MS or Ph.D. in Biotechnology, Cell Biology, Biochemical Sciences or Biochemical Engineering.
- Five Years people supervisory/management experience including performance appraisal and team development preferred.
- Strong Scientific and Engineering Expertise developing processes Hands on experience and competence configuring and operating bioreactors.
- Candidate must possess excellent interpersonal and communication skills to interact with colleagues, clients, suppliers and regulators.
- Candidate with interact with multiple departments: Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Project Management, Materials Management, Sales and Marketing, and Purchasing.
To Apply
For more information or to apply for this position please forward CV to Mr. Mike Mulcahy, Managing Director, BioUETIKON, R&D Building, Dublin City University, Dublin 9, Ireland email: info@biouetikon.com or telephone (+353) (0)1-7007007.
ABOUT BIOUETIKON – CGMP BIOPHARMACEUTICAL PRODUCTION AND PROCESS DEVELOPMENT
BioUETIKON , part of CU Chemie Uetikon GmbH, provides Upstream/Downstream Development and GMP CMO Services to the Biopharmaceutical, medical device and related industries. BioUETIKON is based in Dublin, Ireland serving international and local clients from a flexible high quality facility approximately 15 minutes from Dublin Airport on the DCU Campus. Core competence and experience includes:
- Bioprocess Development, Scale Up and OptimisationGMP Compliant Contract Manufacturing Production in multi suite facility
- Mammalian / Insect Cell Culture Experience including cell banking
- Downstream Processing / Purification Development and GMP Bioprocessing
- QA (Quality Assurance) including in house QP (Qualified Person)
- >10 years experience of API supply
CU Chemie Uetikon GmbH is a well established successful Fine Chemistry/Custom Synthesis/API business based in Lahr, Germany and part of Swiss Industrial Group Chemie + Papier Holdings AG.
