Job Title: Director - Drug Product Technology Transfer
Description:
Bio Marin'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 Bio Marin'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.
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.
This director will be responsible for providing technical and scientific leadership to the Drug Product Internal and External manufacturing network through partnerships with global functions and third-party Commercial Manufacturing Organisation's (CMOs) to introduce new products and technologies. The successful candidate will lead a team of scientists and engineers in the delivery of TT for Drug Product across our Global Manufacturing Network.
Responsibilities:
* Lead a team of scientists and engineers in the delivery of TT for Drug Product across our Global Manufacturing Network.
* Manage and communicate the project portfolio to key stakeholders.
* Identify, recruit, develop and retain qualified individuals to lead Tech Transfer.
* Experienced in authoring, reviewing, and coaching of staff in regulatory filing submissions.
* Create and maintain an environment of teamwork and collaboration while developing and motivating a high performing team that models the organisation values and attributes.
Requirements:
* 10+ years of professional experience in the pharmaceutical industry, including managerial experience.
* Demonstrated ability to lead and develop an effective team of scientists and engineers.
* Broad understanding of Drug Product 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.
Location: Ireland - Cork/Dublin/Remote
Travel: 15-25%
Estimated Salary: €120,000 - €180,000 per annum
Language: English