Senior Manager, Biologics Centre of Excellence
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. Come join our team and make a meaningful impact on patients’ lives.
Senior Manager, Biologics Center of Excellence
Location: Shanbally, Ringaskiddy, Cork
MSAT Biologics, Centre of Excellence (BCoE) and are hiring a Senior Manager, BCoE, Bioprocess Science with the following remit;
- Leadership of Bioprocess Science team that support’s the commercial operations of BioMarin’s commercial product portfolio and collaborate with manufacturing operations, external partners and the BioMarin global product network.
- Accountable for overall delivery of approved strategic scientific product lifecycle management plans and projects in alignment with BioMarin’s 5-year strategy.
- Responsible for delivering the technical agenda as determined by Product Lifecycle Requirements.
- Provide leadership as required in technical investigations as related to data generation/gathering and analysis.
- Accountable for the generation and maintenance of robust lab scale models for drug substance unit 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.
- Accountable for developing and maintaining team professional, technical and scientific competency (i.e. bench strength) through training, mentoring and coaching.
- 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.
- Provide leadership in MSAT, BCoE from commercialization and life cycle management.
- Provide strategic leadership in the build of Biologics CoE.
- Establish and expand manufacturing sciences capability to support Drug Product 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.
- 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.
- Provide leadership for ongoing evaluation of product performance.
- 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 and leading the technical delivery of projects.
- Strong working knowledge of statistics 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.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.