Technical Development Scientist
3 weeks ago
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
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.
Shanbally, Rinaskiddy, Cork - Hybrid role
Responsibilities
- Responsible for technical oversight of a portfolio of biologic Drug Products at external Contract Manufacturing Organizations (CMOs) and internal sites (Cork, Shanbally) including process performance monitoring/optimization, continuous improvement, process robustness and LCM.
- Ensure that Drug Product manufacturing processes perform as developed and validated while ensuring continuous process improvement through the application of scientific and engineering expertise.
- Drive technical requirement for pipeline products assisting late phase and PPQ campaign activities between Technical Development group and External Manufacturing network.
- Ensure 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 technical representative on process teams.
- Act as an SME on biologic Drug Product, including technology transfer, process validation, troubleshooting 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.
- 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).
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 organization.
- 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 field.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
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.
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