MSAT Associate Scientist, Process AnalyticsLocation Cork, Ireland Apply
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.
We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
This position requires technical expertise in process analytics for analyzing proteins, process impurities and other components of a biopharmaceutical process which produces recombinant enzymes.
The role is part of the Manufacturing Sciences and Technology group (MSAT), which is responsible for running small scale versions of manufacturing processes, technology transfer, manufacturing support, process optimization and introducing new technologies. The group has 4 strands of expertise: cell culture, purification, process analytics and data analysis for manufacturing and lab scale processes.
The Associate Scientist analyses samples for the MSAT group and participates in troubleshooting the results by developing assays, trying new tests and working with third party labs to perform tests when the capabilities are not required routinely on site. The lab is not cGMP but adheres to good scientific practices for experimental design and documentation.
This position involves close collaboration within Manufacturing Sciences, and with Quality Control and Manufacturing.
The successful individual will be responsible for the following work:
- Develop and troubleshoot HPLC and UPLC methods needed to support Purification and Cell Culture/Fermentation work in MSAT.
- Running of UPLC/HPLC analytical methods using Empower software.
-Running of capillary electrophoresis methods using 32 Karat software
- Transfer, develop and trouble-shoot analytical methods for protein and glycan analysis.
-Transfer, develop and trouble-shoot analytical methods for Drug Products using equipment such as Rheometer, SEC-MALS and Refractometer.
- Perform other in-process testing methods such as protein quantitation assay, e.g. Bradford, BCA, A280 and protein qualitative methods such as SDS-PAGE and Western Blotting.
-Carry out plate based analytical assays such as kinetic activity/potency and ELISA’s
-Liaise with vendors regarding the installation and qualification of new equipment Develop and help introduce, as required, new analytical methods and technologies.
- Author SOPs as well as transfer, development and qualification reports
- Support Purification and Cell Culture/Fermentation Process Development groups with analytical expertise, testing,data interpretation and statistics.
- Review, analyse and interpret raw data and communicate outcomes.
- Maintain excellent documentation of laboratory work and reports.
- Be a team player with excellent communication and presentation skills.
A Bachelor’s degree in biochemistry, analytical chemistry, biological sciences, or a related field with 4-8+ years of biotechnology and analytical experience
A Masters Degree with 2-5+ years.
Should have 5 or more years of relevant industry experience, particularly in the development of protein-based therapeutics. Demonstrated working knowledge of HPLC hardware and methodology (including RP, HIC, and SEC) is essential, and experience with UPLC and running Empower software is highly desired. Experience with plate based analytical methodology is desired. Additionally, experience with analytical method qualification is required. Should have excellent organizational and communication skills. Knowledge of other analytical techniques, such as mass spectrometry and SEC-MALS, is desired.
WORK ENVIRONMENT / PHYSICAL DEMANDS
Laboratory work and manufacturing support activities will require the use or proximity of chemicals, laboratory and manufacturing equipment and instruments, and mechanical moving parts. Noise and vibration may be present.
Periodic week-end laboratory work and/or on-call support may be required on a team rotation basis.
Equipment is related to cell culture and/or purification, and the analytical instruments are typical in biopharmaceutical labs and manufacturing.
Waters HPLC / UPLC and Beckman Plus 800. Other analytical laboratory equipment such as a UV/VIS spectrophotometer, spectrometric plate reader and protein characterisation equipment required. Experience of Malvern Rheometer, Wyatt SEC-MALS and Protein Simple Maurice is desirable.
• Manufacturing Sciences and Technology
• Quality Control
• Quality and Validation
• Facilities Services
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.