About BioMarin
BioMarin is a global biotechnology company that pursues bold science to develop medicines that advance human health.
Since our founding in 1997, we have applied our expertise in genetics and molecular biology to create transformative medicines for patients with significant unmet medical need.
We enlist the best experts and create an environment that empowers our teams to pursue innovative science.
About Technical Operations
BioMarin's Technical Operations group creates and scales production of our drugs for clinical trials and commercial markets.
These engineers, technicians, scientists, and support staff build and maintain cutting-edge manufacturing processes and sites, ensuring quality assurance and control to meet regulatory standards.
Technical Development Senior Scientist / Engineer Commercial
Job Summary:
This role oversees technical aspects of drug product manufacturing at external Contract Manufacturing Organizations (CMOs) and internal sites.
The successful candidate will drive process improvement, ensure quality, and lead cross-functional teams.
Responsibilities:
* Provide technical oversight for portfolio of biologic Drug Products.
* Ensure Drug Product manufacturing processes perform as developed and validated.
* Drive technical requirements for pipeline products.
* Maintain readiness of processes for commercialization.
Additional Responsibilities:
* Provide technical oversight for product(s) manufacturing/testing executed at external and internal partners.
* Act as Technical Development representative on process teams.
* Lead risk assessments in support of product(s) technology transfers to external partners.
* Identify and lead product and process improvement initiatives.
Requirements:
* Minimum 5 years' experience in biopharmaceutical industry with MSAT and process development experience in Drug Product biologics.
* Working knowledge of pharmaceutical regulatory requirements and cGMP manufacturing process.
* Ability to collaborate in a global team environment.
* Strong working knowledge of statistics, quality systems, and regulatory requirements.
Education:
Minimum B.Sc degree in relevant scientific discipline (M.Sc or PhD preferred).
Salary:$120,000 - $180,000 per year.
Location:Cork, Ireland.
Job Type:Full-time.
Work Schedule:40 hours per week.
About the Company:
BioMarin is 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.