Scientist, Chemical Development and Manufacturing
Description
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. Come join our team and make a meaningful impact on patients’ lives.
- Functioning in the Synthetic Drug Substance group, which is part of the Technical Development & Services organization, the role provides day-to-day oversight and management for synthetic molecule, drug substance contract manufacturing activities, throughout the product lifecycle. As such, handovers from the Research organization and ultimately, transfer to Global External Operations, are habitual.
• Help identify new synthetic routes, process improvements, coordinate technology transfer, while monitoring ongoing improvements at the CDMOs.
• Communicate and coordinate internal evaluation of process changes, change requests, deviations, and OOS findings. Coordinate with BMRN and contractor QA groups to ensure timely evaluation and approval of master and executed batch records, as well as other cGMP documents. Create justifications for changes, which would typically be driven by cost-of-goods, product quality, streamlined procedures and/or logistical simplicity.
• Coordinate with CDMO and BMRN quality and regulatory personnel to support regulatory submissions, to implement new procedures. Contribute to and co-author regulatory filings and other HA communications.
• Drive new CDMO identification and participate in cross functional evaluation, selection and on-boarding.
• Acquire and share knowledge of the contract manufacturing landscape, through interaction with candidate organizations, speculative site visits and attendance at trade shows.
• The position will also serve person-in-the-plant responsibilities, for both critical and routine production activities and will involve interaction with contractor technical staff, for the development and optimization of chemical processes.
• Participate in cGMP compliance audits, as a technical subject matter expert.
• Periodic in person visits to other BioMarin locations, to ensure continued connectivity and alignment, across the internal network.
• Remain up to date with academic and industrial advances, through networking, literature familiarity and conference attendance.
• Lead at the forefront of synthetic chemistry innovation, to ensure new technologies are identified, evaluated and implemented, positioning TDS centrally for cutting edge initiatives. Share learnings at appropriate platforms.
- Bachelors, Masters or PhD level in Chemistry or Chemical Engineering.
- Post-doctoral experience would be an advantage, while business, leadership training or related training credentials, would be desirable.
• Process engineering and/or organic chemistry, at both the research level and in large-scale GMP production.
• Working knowledge of pharmaceutical regulatory requirements, as well as solid cGMP skills.
• Excellent written and oral communication skills; expectation to present frequently, at in house forums.
• Demonstrated capability at handling multiple programs and projects, at the one time.
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Desirable Skills and Experience
• .Experience in Oligonucleotide development and/or manufacture, would be an advantage.
• Familiarity and/or working with ERP and quality documentation systems are desirable, but not required.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.