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.

 Come join our team and make a meaningful impact on patients’ lives. MSAT are now hiring an Associate Director of Small Molecule and Biological Drug Substance.

Duties

• Responsible for the leadership of the Small Molecule Drug Substance & Drug Product and Biologic Drug Substance team including the leadership of engineers and scientists in the delivery of new pipeline products and support to existing commercial products.
• Serve as a member of the Global External Operations MSAT leadership team.
• Provide technical and project management expertise for Small molecule Drug Substance manufacturing
• Provide technical and project management expertise for oral solid dosage manufacturing activities including primary & secondary packaging.
• Provide technical and project management expertise for Biologic Drug Substance including upstream and downstream processes.
• Lead the coordination for all clinical and commercial needs between the various manufacturing groups and the project teams to ensure that all clinical and commercial product needs are defined and met. 
• Partner with early-stage technical development team in the development and commercialization of new products.
• Attend at CMO to monitor technical projects and develop an in-depth knowledge of the manufacturing process and systems at the CMO.
• Provide technical support to CMO process changes, change requests and deviations to ensure timely resolution without impacting on supply.
• Lead technology transfers, new product launches, validation activities with the CMO and internal cross functional teams including Process Development, Regulatory Affairs and Quality departments 
• Develop the small molecule global technical policies, standards and guidelines.
• Identify and lead product and process improvement initiatives that deliver value and improve process reliability.
• Author technical reports to Technology Transfer and regulatory filing
• Financial control and support to legal contract management.
• Perform financial analysis to support new or revised project proposals.
• Work with and travel to CMO’s to jointly identify opportunities to strengthen our Strategic Partnership.

Skills

• Relevant experience as a Associate Director or equivalent in the Biotech/Pharmaceutical with increasing responsibility.
• Excellent organizational, interpersonal communication, and problem-solving skills.
• Ability to find, communicate, and implement ways to continuously improve processes.
• Ability to lead and motivate a team of Engineers and Scientists.
• Independent thinker with demonstrated skills working in teams or leading project teams.
• Ability to multi-task and manage timelines.
• Experience working with and knowledge of ICH guidelines as well as EU, US, JP and ROW regulatory requirements.
• Capable of developing TT strategy and leading the technical delivery of projects.
• Highly developed organizational and project management and influencing skills.
• Process development or technology transfer experience preferred.
• Excellent written, verbal, and presentation communication skills.
• Demonstrated strong analytical skills and judgment.
• 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.
• Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project etc.

Education

• Degree in Engineering, Science or Business Discipline is required.
• Masters in science or Engineering Discipline is preferable.

This role can be based in Cork or Dublin



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.