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 coordinating 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 aSr. Scientist Ito supportantibody, protein/enzyme replacement therapy,gene therapy, small molecule, and/or oligoprograms. Reporting to the Director of Analytical Sciences, this person will be a member of the Analytical Sciencesextended leadership team and a key liaison with our partners. The successful candidate will be a self-motivated, independent, and agile scientist who has proven ability to work in a multi-disciplinary and fast-paced environment.

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

This role will also have supervisory duties to lead a team of scientists and/or research associates. The selected candidate should possess excellent organizational, analytical and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment across analytical sciences pillars and cross-functional collaborators in research and early development as well as quality. The candidate is also expected to monitor team’s work and support in the day-to-day activities of team as well as provide regular feedback on their performance.

An ideal candidate will have significant experience in GC, ICP, HPLC,Spectroscopy, Mass Spectrometry based 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 substance and drug product with a prior knowledge of USP & ICH guidelinesand regulatory submission is critical.

RESPONSIBILITIES

• Lead analyticalmethod development, qualification, and testing for extractable & leachable using ICP-MS/OES, GC-MS and LC-MS.
• Lead analytical method development, qualification, transfer, remediation in support of process development and product characterization activities for clinical and commercial portfolio consisting of small molecules, peptides, proteins, conjugated molecules (PEGylated), gene therapy, oligosacross different phases of CMC development.
• Lead analytical method development, qualification and transfer of spectroscopy-based techniques such as Raman, FTIR, IR and NMR.
• Lead and/or manage CDMO interactions driving the development and implementation of methods supporting overall analytical control strategy.
• Support pre- and post-IND regulatory submission by authoring and reviewing analytical sections and responding to queries from regulatory agencies.
• Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods.
• Prepare, review, and approve analytical and technicalprotocols and reports.
• Document experiments, data, and findings electronically in an accessible manner for inspections.
• Participate in the general lab and instrument maintenance.
• Supervise and mentor team of scientist(s) and research associate(s).

EXPERIENCE

Required Skills:

• Expertise with separation techniques for pharmaceutical development such as GC-FID/MS, LC-MS, various HPLC modes: SEC, IEX, RP, HILIC and detectors (e.g. UV, CAD ELSD), etc.
• Experience with extractable and leachable testing using ICP-MS/OES, GC-MS, LC-MS witha solid understanding of the related regulatory requirements
• Experience with spectroscopy-based techniques for raw material and product testing using Raman, FTIR, IR and NMR.
• Experience in phase appropriate analytical development supporting drugsubstance (DS), drug product (DP) assays and supporting formulation developmentacross both early and late phases.
• Deep understanding of USP & ICH guidelines andregulatory expectations from US, EU, JAPAC, etc. health authorities.
• Experience in authoring, reviewing regulatory submission (IND, INDa, BLA/MAA).
• Excellent scientific and business communication skills (verbal, written, and presentation), strong interpersonal/collaboration skills, and planning skills.
• Prior experience with people management.
• Strong problem-solving skills with sound technically driven decision-making ability.
• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment.

Desired Skills:

• Solid understanding of CMC enablement of drug development.
• Experience with extractable and leachable testing using ICP-MS/OES, GC-MS and LC-MS

• Experience with spectroscopy-based techniques for raw material testing, product testing using Raman, FTIR, IR and NMR.
• Knowledge of small molecule, polymer-conjugatedproteins chemistry
• Potential to serve as CMC Analytical Partner Team Leader for early and/or late-stage products
• Experience managing projects at CROs/CDMOs

EDUCATION

PhD degree in Chemistry, Biochemistry, pharmaceutical chemistryor related field with 5+ years of relevant post-graduate experience.

(OR)

Master’s degree in chemistry, Biochemistry, pharmaceutical chemistry or related field with 10+ years of relevant post-graduate experience.

CONTACTS

Will report to Director of Analytical Sciencesand interface with internal department leaders and external partners from Research and Early Development, Technical Development, Quality, and Regulatory

SUPERVISOR RESPONSIBILITY

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

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