Sr. Scientist 1, Analytical Sciences

BioSpace; Novato (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Sr. Scientist I to join their Analytical Sciences team. This pivotal role involves leading the development and qualification of analytical methods for a range of innovative products, including gene therapies and small molecules. You will collaborate with diverse teams, ensuring compliance with regulatory standards while mentoring junior scientists. This position offers an exciting opportunity to contribute to groundbreaking therapies that can transform patient care. If you are passionate about advancing science and improving health outcomes, this role is perfect for you.

Qualifications

• 5+ years of experience in analytical development for drug substances.
• Expertise in regulatory requirements and documentation.

Responsibilities

• Lead development and qualification of analytical methods for various assays.
• Supervise and mentor team members, providing performance feedback.

Skills

Analytical Method Development

Separation Techniques (GC-FID/MS, LC-MS, HPLC)

Spectroscopy Methods (Raman, FTIR, NMR)

Leadership and Team Management

Regulatory Documentation

Education

PhD in Chemistry or Biochemistry

Master's Degree with 10+ years of experience

Tools

ICP-MS/OES

GC-MS

LC-MS

HPLC

Job description

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BioMarin is a global biotechnology company committed to translating genetic discoveries into new medicines that improve human health.

About BioMarin

Founded in 1997, we focus on understanding genetic conditions to develop transformative medicines across various treatment modalities. Our expertise in genetics and molecular biology supports a pipeline of innovative products with potential first-to-market advantages or significant benefits over existing therapies.

Technical Operations

Our Technical Operations team manages drug manufacturing for clinical trials and commercial use, ensuring quality, regulatory compliance, and efficient distribution worldwide.

Position Summary

The Analytical Sciences team within our Technical Development & Services department seeks a Sr. Scientist I to support diverse programs including antibody, protein/enzyme replacement, gene therapy, small molecules, and oligos. Reporting to the Director of Analytical Sciences, this role involves analytical method development, qualification, transfer, and support for clinical and commercial phases, along with team supervision and collaboration across departments.

Key Responsibilities

• Lead development, qualification, and transfer of analytical methods for various assays, including ICP-MS/OES, GC-MS, LC-MS, spectroscopy, and others.
• Support process development and product characterization activities across different product types and phases.
• Manage regulatory documentation and support submissions by preparing analytical sections and responding to agency inquiries.
• Supervise and mentor team members, monitor their work, and provide performance feedback.

Required Skills and Experience

• Expertise in separation techniques (GC-FID/MS, LC-MS, HPLC, etc.) and spectroscopy methods (Raman, FTIR, NMR).
• Experience with extractable and leachable testing and regulatory requirements.
• Background in analytical development for drug substances and products, with knowledge of USP & ICH guidelines.
• Proven leadership and team management skills.

Educational Qualifications

• PhD in Chemistry, Biochemistry, or related field with 5+ years of relevant experience, or
• Master’s degree with 10+ years of relevant experience.

Additional Information

This role reports to the Director of Analytical Sciences and involves collaboration with multiple internal and external stakeholders. We are an equal opportunity employer committed to diversity and inclusion.