BioMarin Pharmaceutical Inc. Jobs

Research Associate 1, Analytical Services

BioMarin Pharmaceutical Inc.

Research Associate 1, Analytical Services

Posted 2 Days Ago

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Novato, CA, USA

In-Office

Junior

Biotech • Pharmaceutical • Manufacturing

The Role

Performs GxP and non-GxP analytical testing for pharmaceutical drug substances and products. Responsibilities include HPLC and other assay execution, method qualification, validation, transfer, optimization, troubleshooting, documentation, investigations, data analysis, regulatory inspection support, equipment maintenance, cross-functional manufacturing and QC support, training, and laboratory process improvement. This is a fully onsite laboratory role with occasional non-routine work hours.

Summary Generated by Built In

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.

Research Associate, Analytical Services

JOB DESCRIPTION

Research Associate is an onsite laboratory position. The selected candidate will work in the Analytical Services team, under the Analytical Sciences group to assist in the advancement of BioMarin’s therapeutics for clinical evaluation and potential commercialization. The selected candidate will be responsible for applying technical expertise to the execution of laboratory activities related to GxP and non-GxP testing of early clinical programs and their transition to late stage, commercial and post-commercialization.

Under limited supervision, the candidate will ensure phase-appropriate performance, troubleshooting, optimization, qualification, validation, and transfer of methods for testing pharmaceutical drug substance and drug product. In addition, this role will support training for site QC / Global QC / Contract Test Labs / In-Country Testing Laboratories personnel in new techniques and methods. 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

Responsibilities include, but are not limited to the following:

Method Qualification, Validation, Transfer and Optimization

• Lead and/or perform analytical testing such as HPLC/UPLC, Electrophoresis, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, Nucleic Acid Analysis and compendial physicochemical assays.

• Draft and review documents such as, analytical procedures, method validation protocols/reports, experimental designs, verification, and transfer protocols/reports

• Manage and perform activities associated with validation and transfer of QC Methods used to support BioMarin’s in-process, release and stability testing programs to internal laboratories, CTOs, In-Country Test Laboratories and other strategic partners

• Lead/support and document escalated laboratory investigations to identify the root cause and to establish effective corrective and preventative actions with minimal delay

• Provide technical expertise for analytical test methods (optimize, validate, and troubleshoot) to stakeholders in QC, Drug Substance and Drug Product Technology teams

• Support the maintenance of method and analytical equipment performance

• Trend, analyze and interpret analytical results.

• Conduct data review and sign-off in applicable document and data management systems

• Support the performance of project management functions such as: ensuring adherence to timelines, mobilizing stakeholders, prioritization of work efforts, understanding and applying escalation process

Regulatory Compliance, Audit and Site Support

• Lead/support the effort to maintain the laboratory in an inspection-ready state including support of equipment management (e.g., check reference materials for expiration, etc.)

• Support efforts to provide technical support to regulatory agency inspections and audits (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections)

• General understand and application of USP, EP, JP and ICH regulatory guidelines and directives

Cross-Functional Support

• Provide laboratory support to Manufacturing, Quality and QC during manufacturing and/or QC investigations

• Liaise with Analytical Product Leads, Drug Substance and Drug Product Technology Teams, Manufacturing, Quality Control to support GxP testing

Process Improvement and Training

• Act as technical resource (SME) to train other Analysts in areas of expertise

• Support or lead continuous improvement in laboratory operations (procedures and systems) to improve organizational effectiveness and phase-appropriate testing compliance.

Required Skills:

• Experience in performing one or more combinations of analytical methods including HPLC/UPLC, Electrophoresis, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, Nucleic Acid Analysis and compendial physicochemical assays Experience or understanding of GMP/GLP requirements.

• Ability to analyze and interpret data.

• Good written and oral communication skills, with the ability to communicate complex information.

• Strong organizational skills with the ability to effectively multi-task and prioritize.

• Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment.

Desired Skills:

• Experienced in method development, qualification, and transfer.

• Knowledge of biopharmaceutical development is a plus.

• Experience working in a cross-functional environment.

Primarily a laboratory position; contact with chemicals that may be hazardous is part of routine activities. The employee will be trained to use common laboratory equipment and minimize exposure to hazards. Desktop or laptop computer work is also a major component of the job. This is a fully onsite role. The position may require occasional non-routine work hours support.

Education

• Bachelor’s/ in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 2- 4 years of experience in a Biologics or Pharmaceutical environment.

• A Master’s Degree in a related field is desirable, but not required.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
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.

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.

Skills Required

Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field
At least 2–4 years of experience in a biologics or pharmaceutical environment
Experience performing analytical methods such as HPLC/UPLC, electrophoresis, UV spectrophotometry, ELISAs, cell-based bioassays, nucleic acid analysis, or compendial physicochemical assays
Experience or understanding of GMP/GLP requirements
Ability to analyze and interpret data
Strong written and oral communication skills, including communicating complex information
Strong organizational, multitasking, prioritization, flexibility, and execution skills
Experience in analytical method development, qualification, and transfer
Knowledge of biopharmaceutical development
Experience working in a cross-functional environment
Master's degree in a related field

BioMarin Pharmaceutical Inc. Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about BioMarin Pharmaceutical Inc. and has not been reviewed or approved by BioMarin Pharmaceutical Inc..

Healthcare Strength — Benefits are often characterized as comprehensive, spanning medical, dental, vision, life and disability coverage, along with FSAs/HSAs and an EAP. Feedback suggests these health offerings are consistently regarded as strong and at times "industry best".
Leave & Time Off Breadth — Leave and time off are described as generous, with structured vacation progression, dedicated sick time, and a company-observed winter break among many holidays. Feedback suggests this breadth of paid time away is a standout element of the total rewards.
Retirement Support — Retirement support is underpinned by a 401(k) savings plan with a company match. Feedback suggests these retirement programs contribute meaningfully to overall compensation value.

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The Company

HQ: San Rafael, CA

3,270 Employees

Year Founded: 1997

What We Do

Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of the genetic conditions that it seeks to treat, helping to better the lives of those struggling with rare genetic disease. BioMarin discoveries have led to eight first or best-in-class commercial treatments and a pipeline of multiple product candidates applying the same science-driven, patient-forward approach to broader group of genetic disorders. The more innovative solutions developed, the more lives BioMarin can impact. Recruitment Fraud Alert Notice Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral. In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it’s from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity. If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit. We appreciate your interest in BioMarin & encourage you to visit http://careers.biomarin.com/career-areas to review job opportunities.