Senior Associate Scientist DSP
2 days 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.
SUMMARY DESCRIPTION
Job Remit
Plan, perform & document scientific experiments in collaboration with cross-functional stakeholders as part of the MSAT, CoE or Site strategy and/or in support of BioMarin’s commercial & clinical product portfolio. Actively engage with external vendors & service providers in contribution to maintenance of lab instruments & infrastructure.
RESPONSIBILITIES
1. Laboratory /Project work:
In consultation with scientists, project and functional leads, develop, transfer, qualify and/or troubleshoot lab scale processes (US and DS) and analytical methods needed to support activities of a multi-product lab.
2. Support MSAT studies and investigation activities with lab scale processes, analytical testing, data analysis and data interpretation.
3. Develop new techniques, and bring in new technologies, to enhance the lab studies, process understanding and analytical capabilities of the group.
4. Work with MSAT scientists to troubleshoot, identify knowledge gaps and provide process and analytical solutions to increase process understanding, robustness and optimisation.
5. Partner with peers, CoE and cross-functional teams, to review and investigate data, trends and project outputs from the lab scale and commercial/clinical process, and present results, conclusions and implications to project teams and stakeholders.
6. Interface with other departments, site-based and globally, as required, such as Quality, Manufacturing, Process Sciences and partnering Centres Of Excellence.
7. Prepare SOPs, reports and documents such as project charters, characterization protocols and reports, development reports, and testing results data reports.
8. Ensure that cost benefits are delivered according to targets.
9. General:
Independently plan, execute and complete significant projects with minimal supervision.
10. Review, interpret and share raw data with peers & stakeholders.
11. Maintain up-to-date documentation of laboratory work carried out including documentation storage and archiving in accordance with GLP.
12. Support establishment and maintenance of lab instructions, SOPs, templates.
13. Support maintenance and calibration of lab / pilot equipment with accompanying documentation.
14. Contribute to the evaluation of new equipment.
15. Be a team player with excellent communication skills.
16. Play an active role in maintaining and enhancing the safety of the workplace and the laboratories.
17. Comply with applicable GxP regulations, SOPs, HSE, & other guidelines in the laboratory as applicable.
18. May be required to work periodically out of normal business hours.
SCOPE
1. Key Performance Metrics:
Adherence to project plans & deliverables.
2. Adherence to applicable GxP and EHS requirements.
3. Timely and successful implementation of transfer activities (e.g. lab-to-lab transfer in launches).
4. Technical reports executed on time and on quality.
5. Efficient technical exchange with stakeholders (e.g. Engineering, Production, Quality, Process Science...).
EDUCATION
Bachelor’s degree or higher in Science or Engineering.
EXPERIENCE
A minimum of 3 years’ experience in the pharmaceutical industry with a strong laboratory experience. Working knowledge of pharmaceutical regulatory requirements appropriate to level and strong knowledge of the cGMP manufacturing process for Biologics.
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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