Technical Development Senior Scientist Commercial Support

at  Biomarin

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.
Technical Development are hiring for the role of Senior Scientist / Engineer Commercial Support with the following remit:

EXPERIENCE

• A minimum of 5 years’ relevant experience in the biopharmaceutical industry with a strong MSAT and process development experience in Drug Product biologics.
• Working knowledge of pharmaceutical regulatory requirements appropriate to level and strong knowledge of the cGMP manufacturing process.
• Ability to collaborate in a global team environment at all levels of the organisation.
• Ability to start up and lead cross functional teams in the resolution of short-term issues or sustained performance for long-term goals.
• Strong working knowledge of statistics, quality systems and regulatory requirements across multiple health authorities for GMP production of biologics.
• Excellent organizational, written and verbal communication and negotiation skills.
• Experience with Change Control, Deviation, CAPA, FMEA, RCA tools in a highly regulated manufacturing environment.
• Demonstrated strong leadership and coaching qualities.

EDUCATION

• Minimum B.Sc (M.Sc. or PhD Preferred) degree in relevant scientific discipline e.g. biochemistry, microbiology, biological sciences or related biopharmaceutical science.
  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

• Provide technical oversight for product (s) manufacturing/testing executed at external and internal partners.
• Act as Technical Development technical representative on process teams.
• Act as an SME on biologic Drug Product, including technology transfer, process validation, trouble shooting and investigation on specific product(s).
• Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools.
• Initiate and lead product improvement projects, involving cross-functional teams.
• Establish and maintain internal / external network relationships around control strategy.
• Performs statistical data analysis to recognise trends, identify and drive process improvement or minimise product impact.
• Assist technical and project management leadership during technology transfers.
• Lead risk assessments in support of product(s) technology transfers to external partners.
• Identify and lead product and process improvement initiatives to reduce COGM (Cost of Goods Manufactured).

Process Development/Optimisation

• Develop data driven strategies for process development / product characterisation.
• Develop designs of experiments for execution of lab studies/analytical work with a high level of autonomy.

Late Phase Clinical and PPQ Campaign Activities

• Provide technical input into site selection for late phase to commercial manufacture.
• Provide technical oversight / assistance of late phase campaign at external and internal partners.
• Investigations support / leading role depending on type of investigation.
• Campaign monitoring.
• Provide on-site support (Person in Plant) to external and internal partners.
• Assist PPQ Campaign readiness and execution.
• Identify technical areas to be completed prior to PPQ.
• Raise and drive change control including justification of changes vs previous campaign.
• Maintain/update process technical document and product risk register.
• Ensure stage gate milestones requirement are met.