Sr. Scientist 1, Analytical Sciences

Lyten; Novato (CA); On-site; USD 128,000 - 176,000; Full time

Job summary

An established industry player is seeking a Sr. Scientist I to join their Analytical Sciences team. This role involves leading analytical method development and qualification for various drug programs, including antibody and gene therapy. The ideal candidate will have a strong background in analytical techniques such as HPLC and mass spectrometry, along with experience in regulatory submissions. You will work in a dynamic, multi-disciplinary environment, supervising a talented team while contributing to innovative drug development. This is a unique opportunity to make a significant impact in the biotechnology field and advance your career in a supportive and collaborative setting.

Qualifications

• 5+ years of experience in analytical method development and qualification.
• Expertise in separation techniques and regulatory submissions.

Responsibilities

• Lead analytical method development and qualification for drug products.
• Supervise and mentor a team of scientists and research associates.

Skills

Analytical Method Development

GC

HPLC

Mass Spectrometry

Spectroscopy

Problem Solving

Communication Skills

Team Leadership

Education

PhD in Chemistry

Master's Degree

Tools

ICP-MS

GC-MS

LC-MS

FTIR

NMR

Job description

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 coordinate the worldwide movement of our drugs to patients.

Summary

The Analytical Sciences team within the Technical Development & Services department at BioMarin Pharmaceutical Inc. is seeking a Sr. Scientist I to support antibody, protein/enzyme replacement therapy, gene therapy, small molecule, and/or oligo programs. Reporting to the Director of Analytical Sciences, this person will be a member of the Analytical Sciences extended leadership team and a key liaison with our partners. The successful candidate will be a self-motivated, independent, and agile scientist with proven ability to work in a multi-disciplinary and fast-paced environment.

The primary responsibilities include analytical method development, qualification, transfer to internal and external labs to support clinical & commercial phases of drug development, and quality control for commercial testing. This individual will also manage extractable & leachable testing, material analysis, and product characterization from early to late-stage development, designing and executing methods to develop a deep understanding of product attributes and enabling phase-appropriate in-process monitoring and development of critical quality attributes for routine, stability testing.

This role involves supervisory duties, leading a team of scientists and research associates. The candidate should possess excellent organizational, analytical, and communication skills, be a self-starter, and work efficiently and collaboratively across analytical science pillars and cross-functional teams in research, development, and quality. Monitoring team work and providing regular feedback are also expected.

An ideal candidate will have significant experience with GC, ICP, HPLC, Spectroscopy, Mass Spectrometry assays, analytical method development, qualification, and data handling. Experience in analytical development for small molecules, peptides, proteins, conjugated molecules (PEGylated), oligos, gene therapy (LNP, AAV) drug substances, and drug products, with knowledge of USP & ICH guidelines and regulatory submission, is critical.

Responsibilities

• Lead analytical method development, qualification, and testing for extractable & leachable using ICP-MS/OES, GC-MS, and LC-MS.
• Lead analytical method development, qualification, transfer, and remediation supporting process development and product characterization for clinical and commercial portfolios across various phases of CMC development.
• Lead analytical method development, qualification, and transfer of spectroscopy-based techniques such as Raman, FTIR, IR, and NMR.
• Manage CDMO interactions to develop and implement methods supporting overall analytical control strategy.
• Support pre- and post-IND regulatory submissions by authoring and reviewing analytical sections and responding to agency queries.
• Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods.
• Prepare, review, and approve analytical and technical protocols and reports.
• Document experiments, data, and findings electronically for inspections.
• Participate in lab and instrument maintenance.
• Supervise and mentor a team of scientists and research associates.

Experience

Required Skills:

• Expertise in separation techniques such as GC-FID/MS, LC-MS, HPLC modes: SEC, IEX, RP, HILIC, with various detectors.
• Experience with extractable and leachable testing using ICP-MS/OES, GC-MS, LC-MS, with understanding of regulatory requirements.
• Experience with spectroscopy techniques including Raman, FTIR, IR, NMR.
• Experience supporting drug substance and drug product assays across phases.
• Deep understanding of USP & ICH guidelines and regulatory expectations.
• Experience in authoring and reviewing regulatory submissions.
• Excellent communication, interpersonal, and planning skills.
• Prior management experience.
• Strong problem-solving skills and decision-making ability.
• Ability to deliver in a fast-paced, multi-tasking environment.

Desired Skills:

• Understanding of CMC enablement of drug development.
• Experience with extractable and leachable testing.
• Knowledge of small molecules, polymers, conjugated proteins chemistry.
• Potential to serve as CMC Analytical Partner Team Leader.
• Experience managing projects at CROs/CDMOs.

Education

PhD in Chemistry, Biochemistry, Pharmaceutical Chemistry, or related field with 5+ years of relevant post-graduate experience, OR Master's degree with 10+ years of experience.

Contacts

Reports to the Director of Analytical Sciences and interfaces with internal departments and external partners from Research, Development, Quality, and Regulatory.

Supervisor Responsibility

Supervise, mentor, and manage a team of Scientists and Research Associates.

We are an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability, veteran status, or any characteristic protected by law.

The salary range is $128,000 to $176,000, with potential bonuses, stock incentives, benefits, and other compensation considerations.