Associate Director, Drug Substance Technology Transfer
2 days ago
Who We Are
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.
Associate Director, Drug Substance Technology Transfer - Cork or Dublin (Hybrid)
Biologics Centre of Excellence, Drug Substance Technologies are hiring for an Associate Director Drug Substance Technology Transfer to establish a best in class Tech Transfer team in our ever expanding facility in Cork.
Technical and Scientific Leadership
- Provide technical and scientific leadership to the Manufacturing Network through partnerships with global functions and third-party Commercial Manufacturing Organisation’s (CMOs) to introduce new products and technologies across our internal & external network.
- Accountable for the project execution and delivery of successful process characterisation, engineering, process performance and support to regulatory filing across all modalities.
- Driving excellence in Tech Transfer execution for Drug Substance
- Project Portfolio Ownership.
Technology Transfer team are responsible for:
- Being the primary interface between Manufacturing Operations (Drug Substance) and the Drug Substance Technology wider team for Technology Transfer and LCM.
- The delivery of Technology Transfer across our Manufacturing Network and successful handover to operations team.
- Supporting the development and execution of the Strategy through Tech Transfer for the operational site.
- Successful Partnership with Technical Development & Services and Operations in the delivery of the product development pipeline and commercialisation strategy.
The role will combine scientific, engineering, and operational leadership. This position requires a high degree of familiarity with cGMP and Quality Systems involved with commercial manufacturing processes.
Leadership
- Lead a team of scientists and engineers in the delivery of TT for Drug Substance across our Manufacturing Network.
- Manage and communicate the project portfolio to key stakeholders.
- Identify, recruit, develop and retain qualified individuals to lead Tech Transfer for our Manufacturing Network.
- Create and maintain 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 Biologics Centre of Excellence, BCoE leadership team, who impacts decision making and takes an active role in promoting initiatives, teamwork, and collaboration across functions.
- 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.
- Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools.
- Participate in Global Partner Teams and CMC team as required.
Experience
- 10+ years of professional experience in the pharmaceutical industry, including managerial experience.
- Demonstrated to lead and develop an effective team of scientists and engineers.
- Proven track record of Technology Transfer in Drug Substance
- A broad understanding of Drug Product, Small Molecule Devices 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.
- 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.
Education
- Degree in Engineering, Science or Business Discipline.
- PhD / master’s in science or engineering Discipline is preferable.
Travel: 20-30% within Europe
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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