SCIENTIST 1/2, ANALYTICAL SCIENCES

Website BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc.

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, a part of Technical Development within Tech Ops, supports all assay needs in Tech Ops. Our 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 processes by analyzing in-process samples from bioreactors through purification steps to the drug substance and developing release assays for transfer to Quality. 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 Scientist 1/2 to join a mass spectrometry-based team focused on supporting oligonucleotide, small molecule, gene, and enzyme replacement therapies. The successful candidate will be a self-motivated, independent, and scientifically agile scientist who has proven ability to work in a multi-disciplinary and fast-paced environment.

The primary set of responsibilities will be LC and LC/MS based product characterization and 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. A good scientific understanding of protein chemistry and biochemistry is essential. Hands-on experience in oligos and small molecules with a prior knowledge of ICH and regulatory submission is a plus.

RESPONSIBILITIES

Development and execution of primarily LC and LC/MS based analytical methods for the development and characterization of oligonucleotides, small molecules and biologics at different clinical stages.
Development of analytical methods using size exclusion, ion exchange, reverse phase chromatograms and capillary electrophoresis.
Provide the data in a quality presentation form (methods, qualification report, development report, memo, comparability report, etc) to support regulatory submissions.
Present data proactively and regularly in group and department meetings.
Track progress against project timelines, generate regular status updates and communicate progress and issues to manager.
Document experiments, data, and findings electronically in an accessible manner for inspections.
Participate in the general lab and instrument maintenance.

EXPERIENCE

Required Skills:

Expertise in separations science, including but not limited to: RP, IEX, SEC, HILIC, and HIC
Expertise in mass spectrometry, including ESI and MALDI ionization with a range of mass spectrometer designs (Q-TOF, Orbitrap, QQQ), and standard chromatographic detectors (UV, FLR, ELSD, CAD, RI, MALS)
Hand-on experience in protein biochemistry (e.g. SDS-PAGE, Western Blot, Immunoprecipitation)
Strong organizational and communication skills and effective interpersonal skills
Ability to learn new technologies fast with good problem-solving skills
Proven technical skills in a cross-functional and collaborative environment
Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment

Desired Skills:

Experience in chromatography and mass spectrometry.
Knowledge of biopharmaceutical development.
Knowledge of oligos and small molecules development is a plus.

EDUCATION

PhD degree in Biology, Chemistry or related field with 0-2+ years of relevant post-graduate experiences for Scientist 1, or 2-5+ years of relevant post-graduate experiences for Scientist 2.

CONTACTS

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

SUPERVISOR RESPONSIBILITY

May supervise, mentor, and manage Research Associates.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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.

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