CareerWise Recruitment are currently recuiting an ASSOCIATE DIRECTOR for the TECHNICAL SERVICES / MANUFACTURING SCIENCE LABORATORY for our client at their new Biologics facility in Limerick.
The ASSOCIATE DIRECTOR, TECHNICAL SERVICES / MANUFACTURING SCIENCE LABORATORY will lead a technically comprehensively laboratory group to provide support to the Limerick biologics manufacturing processes. Responsibilities will include oversight of TS/MS business processes, support of new product introduction and commercialisation, business continuity and productivity project development, with the overall goal of supporting the site's technical agenda.
Role of this position
- Understand the scientific principles of biologics manufacturing, including the interaction of the chemistry, equipment and operators to teach, mentor and develop biologists, biochemical engineers and chemists
- Support site leadership to build a diverse and capable TS/MS organization with the necessary capability, capacity and culture to operate the facility to the highest standards of excellence.
- Determine TS/MS staffing and resource needs to support laboratory operations through facility startup to enable successful process qualifications and validations
- Support the design of the laboratory space and purchase, implement and qualify cell culture and purification equipment in the TS/MS laboratory in alignment with the broader project timeline
- Ensure representative laboratory scale-down models of process equipment and process analytical technologies are developed and implemented
- Review and approve GMP and GLP documentation including procedures, deviation investigations and technical reports
- Support the project team to ensure the TS/MS laboratory is delivered to the site lead team ready to operate safely to support facility startup.
- Hons Degree Qualified - BS, MS, or PhD in biology, biochemistry, chemistry, chemical engineering, or related scientific discipline
- Minimum of fives years of leadership experience and proven capabilities within a biologics GMP manufacturing environment.
- Knowledge of cell culture and/or purification techniques used in the manufacturing of biotech products.
- Knowledge of qualification and validation requirements and good manufacturing and laboratory practices
- Knowledge of laboratory and commercial scale biotech manufacturing processes
- Strong written and verbal communication skills
- Ability to work on own initiatives and as part process team consisting of a diverse group of management, production, laboratory, science and engineering professionals.
- Ability to respond quickly and proactively to changing priorities within a limited timeline.
Please call Conor Twomey today for further information on 087-0907204 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)