(CW) Sr Research Associate II (TEMPORARY)

BioMarin Pharmaceutical Inc.; Novato (CA); Vor Ort; USD 42.705 - 68.880; Vollzeit

Benefits dieser Stelle

Benefits package

Zusammenfassung

BioMarin Pharmaceutical Inc. in Novato, CA, seeks an analytical scientist to advance separations and biophysical assays for clinical evaluation and potential commercialization.

You will develop and qualify methods for proteins, peptides, and conjugates, perform routine testing, and support upstream/downstream development while documenting results in Benchling. This onsite role emphasizes collaboration, quality, and regulatory readiness.

Qualifikationen

• Hands-on experience with biologics-focused analytical testing and characterization.
• Knowledge of method development, qualification, and transfer.

Aufgaben

• Support Separations and Biophysics group in Analytical Sciences.
• Be hands-on in the lab, supporting biophysical/biochemical assay development and qualification using HPLC and CE (must have) for various modalities.
• LC-MS (high-res) experience is desirable.
• Document results in Benchling; author procedures and development reports.
• Participate in lab safety, organization, ordering, and maintenance.
• Present literature and results at group meetings and forums.
• Other duties as assigned.

Kenntnisse

HPLC/CE methods

LC-MS

Biologics experience

Analytical testing

Troubleshooting

Ausbildung

BSc in Chemistry/Analytical Chemistry/Bioengineering

MS in Chemistry/Biochemistry/Analytical Chemistry

Tools

LC instruments (Agilent/Waters/Thermo)

Jobbeschreibung

Who We Are

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. 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.

Contract role – onsite in Novato (5 days a week, 8‑hour days) with occasional evening or weekend work required.

Job Description

The selected candidate will work in the Separations and Biophysical Assays team within the Analytical Sciences group to assist in the advancement of BioMarin's therapeutics for clinical evaluation and potential commercialization. The candidate will be responsible for method development (separations), provide routine testing and characterization support to partner groups to help with early candidate selection, process development, and drug substance and drug product process characterization. The ideal candidate will have hands‑on experience working with biologics including but not limited to proteins, peptides, protein‑conjugates, enzymes, biologics with a focus on method development and in‑depth characterization. The ideal candidate will be able to perform quality work under limited supervision, apply problem‑solving techniques to maintain accurate results, promote improvements, and assure a safe, stable, on‑target operation within the laboratory. The selected candidate should possess excellent analytical, organizational and communication skills and be a self‑starter willing to work efficiently and collaboratively in a dynamic environment.

Responsibilities

• Support the Separations and Biophysics group within Analytical Sciences.
• Be a hands‑on presence in the laboratory, supporting biophysical/biochemical assay development and qualification using HPLC and CE (must have) for various modalities (preferably biologics). LC‑MS (high‑res) experience is also desirable.
• Provide routine analytical characterization & testing support to partner groups including Upstream and Downstream PD, Formulations, and Research & Early Development (RED).
• Document experimental results in the company electronic lab notebook (Benchling), author procedures, and contribute to technical documentation (test methods, development reports).
• Actively participate in the operational aspects of the laboratory by conducting safety inspections, lab organization, ordering supplies, and performing routine equipment maintenance.
• Present scientific literature and results from ongoing studies at group meetings and other discussion forums at the company.
• Other duties as assigned.

Required Skills

• Hands‑on experience in the biotechnology industry or academic setting with a broad range of analytical techniques focused on analytical testing and characterization for proteins, peptides, and protein‑conjugates.
• SEC, SCX, RP‑HPLC experience is a must (Agilent/Waters/Thermo LC instruments).
• Capillary Electrophoresis (PA800 or BioPhase8800) based methods (SDS for size separation, glycan profiling).
• cIEF (Maurice) experience is highly desirable.
• LC‑MS (Orbitrap/QToF/QQQ) method development experience also desirable.
• Technical understanding of all aspects of analytical testing, phase‑appropriate regulatory requirements, method qualifications, and method transfers.
• Ability to independently troubleshoot issues, ideate, and develop insights into technical challenges and propose solutions to solve them.
• Demonstrates attention‑to‑detail and "right‑the‑first‑time" approach.
• Excellent written and oral communication skills, with the ability to communicate complex information. Be able to present data/ideas to functional and cross‑functional teams.
• Ability to influence others effectively and develop collaborative relationships with partner teams.
• Familiar with use of statistical software, electronic document management, and laboratory information management.
• Ability to effectively analyze complex problems and present results effectively within and beyond the department.
• Ability to flexibly adapt to changing business needs and meet timelines.
• Strong organizational skills with the ability to effectively multi‑task and prioritize.

Desired Skills

• Experience in method development, qualification, and transfer to/from other laboratories such as development, quality control.
• Knowledge of biopharmaceutical process development is a plus.
• Experience with automation is a plus.
• Experience working in a cross‑functional environment.
• Good understanding of root cause analysis methodology.

Education

• Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 6+ years of experience in a Biologics or Pharmaceutical environment.
• Master's degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 4+ years of experience in a Biologics or Pharmaceutical environment.

Work Environment / Physical Demands

This role is primarily a laboratory position; contact with chemicals is part of the job. The role is fully onsite (5 days a week, 8‑hour days) with occasional evening or weekend work required. The employee will be trained to use common lab equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.

Employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities in this job include close vision, depth perception and ability to adjust focus.

Equipment

Analytical laboratory equipment.

Equal Opportunity Employer / Veterans / Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Salary

In the U.S., the salary range for this position is $31 to $50 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job‑related knowledge, skills, and experience. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.