Technical Development Senior Scientist Commercial Support
Client: BioMarin
Location: Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 9ec403ea547b
Job Views: 89
Posted: 03.03.2025
Expiry Date: 17.04.2025
Job Description:
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.
JOB REMIT
1. Responsible for technical oversight of a portfolio of biologic Drug Products at external Contract Manufacturing Organizations (CMOs) and internal sites including process performance monitoring/optimization, continuous improvement, process robustness and LCM.
2. Ensure that Drug Product manufacturing processes perform as developed and validated while ensuring continuous process improvement through the application of scientific and engineering expertise.
3. Drive technical requirements for pipeline products assisting late phase and PPQ campaign activities between Technical Development group and External Manufacturing network.
4. Ensure readiness of processes for commercialization.
RESPONSIBILITIES
1. Provide technical oversight for product(s) manufacturing/testing executed at external and internal partners.
2. Act as Technical Development technical representative on process teams.
3. Act as an SME on biologic Drug Product, including technology transfer, process validation, troubleshooting, and investigation on specific product(s).
4. Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools.
5. Initiate and lead product improvement projects, involving cross-functional teams.
6. Establish and maintain internal/external network relationships around control strategy.
7. Perform statistical data analysis to recognize trends, identify and drive process improvement or minimize product impact.
8. Assist technical and project management leadership during technology transfers.
9. Lead risk assessments in support of product(s) technology transfers to external partners.
10. Identify and lead product and process improvement initiatives to reduce COGM (Cost of Goods Manufactured).
EXPERIENCE
1. A minimum of 5 years’ relevant experience in the biopharmaceutical industry with a strong MSAT and process development experience in Drug Product biologics.
2. Working knowledge of pharmaceutical regulatory requirements appropriate to level and strong knowledge of the cGMP manufacturing process.
3. Ability to collaborate in a global team environment at all levels of the organization.
4. Ability to start up and lead cross-functional teams in the resolution of short-term issues or sustained performance for long-term goals.
5. Strong working knowledge of statistics, quality systems and regulatory requirements across multiple health authorities for GMP production of biologics.
6. Excellent organizational, written and verbal communication and negotiation skills.
7. Experience with Change Control, Deviation, CAPA, FMEA, RCA tools in a highly regulated manufacturing environment.
8. Demonstrated strong leadership and coaching qualities.
EDUCATION
1. 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.
#J-18808-Ljbffr