Senior Manager, Biologics Centre of ExcellenceLocation Cork, Ireland Workstyle Open to Hybrid Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Manufacturing Science and Technology, MSAT Frontline are responsible for being;
- The primary interface between Manufacturing Operations (Drug Substance, Drug Product & Packaging) and the MSAT wider team, supporting a given product and/or process prior to, during and post-campaign.
- Ensure that the manufacturing process performs as developed and validated while ensuring continuous process improvement through the application of scientific and engineering expertise.
- Responsible for technical leadership of the technology transfer, process scale up, process performance monitoring/optimization, continuous improvement, and impact analysis.
The role will combine scientific, engineering, and operational leadership as well as utilising Root Cause Analysis, Statistical Analysis and Experimental Design. Furthermore, this position requires a high degree of familiarity with cGMP and Quality Systems involved with commercial manufacturing processes.
MSAT Biologics, Centre of Excellence (BCoE) and are hiring a Senior Manager, BCoE with the following remit;
- Provide technical and scientific front line leadership through partnerships with site, global functions and third parties to introduce and maintain commercially viable and robust products.
- Responsible for the introduction of products and for transfers from Process Sciences and other sites or external contracted organisations for third party products.
- Lead the Biologics CoE Front Line team of scientists and engineers responsible for technical oversight of the Drug Substance & Drug Product, Packaging operations.
- Identify, recruit, develop and retain qualified individuals to provide technical support to the site. Creates and maintains an environment of teamwork and collaboration while developing and motivating a high performing team that models the organisation values and attributes.
- Serve as an influential member of the BCoE leadership team, who impacts decision making and takes an active role in promoting initiatives, teamwork and collaboration across functions.
- Responsible for the technical delivery of New Product Introduction and Technology Transfer projects through close collaboration internally, ensuring compliance with specifications, regulatory guidelines, and right first-time delivery.
- Establish and expand manufacturing sciences capability to support Drug Product & Packaging operations.
- Partner with BCoE leadership to provide technical expertise and discussion during GMP audits from regulatory authorities.
- Ensure personal understanding of all quality policy/BioMarin system items that are per training curriculums.
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
Commercial Operations –
- Support the start-up of the Drug Product facility, by interfacing and developing a close working relationship between the manufacturing sciences lab team and Drug Product manufacturing.
- Provide leadership as required in technical investigations and assessment of deviations particularly as related to data generation/gathering and analysis.
- Lead and identify product and process improvement initiatives that deliver value and improve process reliability.
- Partner with Global MSAT Leadership to increase process robustness and reduce Cost of Goods Manufactured (COGM)
- Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
- Partner with Process Steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
- Experience in the Biopharma, experience in Process Development and MSAT organizations is desirable.
- 7+ years of professional experience in the pharmaceutical industry, including managerial experience.
- Demonstrated to lead and develop an effective team of scientists and engineers.
- A broad understanding of Drug Substance, Product & Packaging, and a keen sense of business acumen.
- Experience collaborating effectively with other functional groups to achieve business objectives.
- Effective decision-making skills – ability to negotiate and balance decisions and priorities across needs of multiple stakeholders.
- Demonstrated initiative; results oriented, initiative to institute change.
- Capable of developing TT strategy and leading the technical delivery of projects.
- Strong working knowledge of statistics, quality systems and regulatory requirements across multiple health authorities for GMP production of Biologics.
- Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network.
- Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment.
- Degree in Engineering, Science or Business Discipline is required.
- PhD / Master’s in Science or Engineering Discipline is preferable.
This role is Cork based
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.