**About Bio Marin**
Bio Marin is a global biotechnology company that pursues bold science to translate genetic discoveries into new medicines advancing human health.
We have applied our scientific expertise in understanding genetic conditions to create transformative medicines using multiple treatment modalities.
With our unique approach to drug discovery, we've produced a diverse pipeline of commercial, clinical, and preclinical candidates with well-understood biology.
**Technical Operations Group**
The Technical Operations group creates drugs for clinical trials and scales production for the commercial market.
Engineers, technicians, scientists, and support staff build and maintain Bio Marin's cutting-edge manufacturing processes and sites, ensuring quality assurance and control to meet regulatory standards.
They also procure goods and services to support manufacturing and coordinate the worldwide movement of drugs to patients.
**Responsibilities**
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 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.
Perform statistical data analysis to recognize trends, identify, and drive process improvement or minimize 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).
**Requirements**
A minimum of 5 years' relevant experience in the biopharmaceutical industry with strong MSAT and process development experience in Drug Product biologics.
Working knowledge of pharmaceutical regulatory requirements and c GMP manufacturing process.
Ability to collaborate in a global team environment and start up/lead cross-functional teams.
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 skills and negotiation skills.
Experience with Change Control, Deviation, CAPA, FMEA, RCA tools in a highly regulated manufacturing environment.
Demonstrated strong leadership and coaching qualities.