Sr. Scientist 1, Analytical Sciences

DESCRIPTION

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. The Analytical Sciences department supports all assay needs in Tech Ops. Our 50+ scientists and associates are experts in analytics of small molecules, peptides, proteins/enzymes, and gene therapy agents. We develop assays to follow the quality attributes of our products, support IND and BLA applications, and assess the capability of our production processes. We develop release assays and are responsible for lot release and formal stability testing for early-stage clinical programs (tox, development, GMP lots), and support assay transfer to Quality for late-stage programs. We are also instrumental in time-critical analysis support to Manufacturing as needed. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

The Analytical Sciences department at BioMarin Pharmaceutical Inc. is seeking a Sr. Scientist 1 to support small molecule, oligonucleotide, gene, and enzyme replacement therapies programs. 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 to support clinical-phase development and commercial process transfer/investigations/optimizations. 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. 

An ideal candidate will have significant experience in HPLC, Mass Spectrometry based assays, analytical method development, and data handling. Experience in analytical development for small molecules drug substance and drug product with a prior knowledge of ICH and regulatory submission is a plus.

RESPONSIBILITIES

• Lead analytical development, transfer, qualification, and product characterization activities for small molecules in CMC development including managing CDMO interactions and driving the development and implementation of 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 technical reports.
• Document experiments, data, and findings electronically in an accessible manner for inspections.
• Participate in the general lab and instrument maintenance.
• Supervise and mentor scientists and research associates.

EXPERIENCE

Required Skills:

• In-depth understanding of CMC enablement of small molecule drug development.
• Expertise with the current analytical techniques for pharmaceutical development such as LC-MS, various HPLC modes and detections, dissolution testing, GC-FID/MS, ICP-OES/MS, etc.
• Experience developing drug product tests and supporting formulation development.
• Extensive experience leading analytical activities in small molecule drug development with experience in both early and late phases.
• Working experience and knowledge of regulatory submission (IND, IMPD, and/or NDA, MAA).
• Excellent scientific and business communication skills (verbal, written, and presentation), strong interpersonal/collaboration skills, and planning skills.
• 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:

• Experience managing projects at CROs/CDMOs.
• Knowledge of analytical development for synthetic molecule drugs (e.g. small molecule, oligonucleotide, peptide).
• Experience with authoring CMC documents for regulatory submissions.
• Experience with people management.

EDUCATION

PhD degree in Biology, Chemistry or related field with 5+ years of relevant post-graduate experiences.

CONTACTS

Will report to a PhD Sr. Scientist 2 in Analytical Sciences.

SUPERVISOR RESPONSIBILITY

Supervise, mentor, and manage Scientists and Research Associates - 3 direct reports at this time.

Hybrid role based in Novato, CA.  BioMarin defines hybrid as 2-4 days per week onsite.  

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.

In the U.S., the salary range for this position is $ 125,400 to $ 188,200 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.