SUMMARY

The Center of Technology (CoTe) is a new, centralized laboratory built around platform technologies and made available to scientists and physicians across Worldwide Research and Development (WWRD) of BioMarin. The Mass Spectrometry (MS) Core within the CoTe provides collaboration, expert advice, service, training, and open access to state-of-the-art MS technologies to the entire scientific community of WWRD. Our lab contains 16 mass spectrometers, including Orbitraps, QQQs, Q-Traps, Q-TOFs (ESI + MALDI), and GC-MS.

We are searching for a highly-motivated and experienced bioanalytical scientist to develop and implement LC/MS-based bioanalytical assays and workflows that will accelerate drug discovery and development at BioMarin. This position offers a unique career opportunity to work on the entire spectrum of a product lifecycle, from early drug discovery and non-clinical work through all stages of clinical development, including post-marketing work.  The successful candidate will work directly with colleagues from the CoTe, Research, and Clinical to explore a diverse range of disease areas and treatment modalities. This person will be in a position to apply LC/MS-centric platforms to accelerate drug discovery and development, while maintaining a critical eye on assay quality and maintaining regulatory standards, when applicable.

Specifically, we are looking for a motivated and driven bench scientist with ≥4 years of experience of LC/MS-based bioanalytical method development and implementation. Experience with GLP and/or GCP-compliance as well as regulatory filing is desired.

This Scientist II position will report to the Director of the MS Core within the CoTe, and will have the opportunity to influence the evolution of the larger CoTe department. This person will develop and implement new MS-centric platforms, design and execute analytical strategies to facilitate drug discovery and development, present experiment results and data interpretation in multi-disciplinary project meetings, and contribute to technical documents (e.g. assay development/characterization reports, SOPs, etc). This person may also mentor junior lab staff, evaluate analytical technologies and methodologies, and contribute to scientific publications and regulatory submissions, as required.

RESPONSIBILITIES

• Develop analytical methods and workflows to quantify drugs, metabolites and biomarkers in various biological matrices. Techniques may include (but are not limited to) mass spectrometry, HPLC/UPLC, micro-flow LC and nano-flow LC.
• Present results, conclusions, and implications to Research and Translation Sciences clients and early development teams.
• Develop new workflows, or bring in new technology from the outside, to enhance the analytical capabilities of the MS Core or CoTe, more broadly.
• Provide guidance and mentorship to junior lab staff, and provide training/support to ‘self-service’ users of the MS Core.
• Prepares SOPs and other documents such as assay development reports and data reports for testing results.
• Share responsibility for lab management and maintenance duties.
• Serve as Bioanalytical Study Monitor for outsourced assays, participate in audits and inspections, and adhere to regulatory compliance standards, when applicable.
• Participates in scientific meetings and produces original peer-reviewed publications.
• Other duties as assigned.

EDUCATION

Doctorate (Ph.D.) or M.S. degree in Biology, Chemistry or related field with a research emphasis on mass spectrometry or chromatography applications or instrument design. Established field of expertise in bioanalysis, analytical chemistry, instrumental analysis, or similar.

EXPERIENCE

At least 4 years (8 years for M.S.) of hands-on experience using mass spectrometry and liquid chromatography in a biological or biochemical field. Ability to solve complex problems independently. Experience with GLP and/or GCP-compliance and regulatory filing is a plus. Excellent verbal and written communication skills.