About BioMarin
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.
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.
Job Description
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
* 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.
* Support MSAT studies and investigation activities with lab scale processes, analytical testing, data analysis and data interpretation.
* Develop new techniques, and bring in new technologies, to enhance the lab studies, process understanding and analytical capabilities of the group.
* Work with MSAT scientists to troubleshoot, identify knowledge gaps and provide process and analytical solutions to increase process understanding, robustness and optimisation.
* 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.
* Interface with other departments, site-based and globally, as required, such as Quality, Manufacturing, Process Sciences and partnering Centres Of Excellence.
* Prepare SOPs, reports and documents such as project charters, characterization protocols and reports, development reports, and testing results data reports.
* Ensure that cost benefits are delivered according to targets.
General Responsibilities
* Independently plan, execute and complete significant projects with minimal supervision.
* Review, interpret and share raw data with peers & stakeholders.
* Maintain up-to-date documentation of laboratory work carried out including documentation storage and archiving in accordance with GLP.
* Support establishment and maintenance of lab instructions, SOPs, templates.
* Support maintenance and calibration of lab / pilot equipment with accompanying documentation.
* Contribute to the evaluation of new equipment.
* Be a team player with excellent communication skills.
* Play an active role in maintaining and enhancing the safety of the workplace and the laboratories.
* Comply with applicable GxP regulations, SOPs, HSE, & other guidelines in the laboratory as applicable.
* May be required to work periodically out of normal business hours.
Scope
Key Performance Metrics:
* Adherence to project plans & deliverables.
* Adherence to applicable GxP and EHS requirements.
* Timely and successful implementation of transfer activities (e.g. lab-to-lab transfer in launches).
* Technical reports executed on time and on quality.
* Efficient technical exchange with stakeholders (e.g. Engineering, Production, Quality, Process Science...).
Requirements
* Bachelor's degree or higher in Science or Engineering.
* 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.
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.