QC Scientist II or Senior Scientist

BioMarin Pharmaceutical   •  

Novato, CA

Industry: Biotech/Pharma

  •  

11 - 15 years

Posted 298 days ago

This job is no longer available.

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.

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. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

BioMarin is seeking a Molecular Analytical Scientist within the QC Viral Vector group (Scientist II to Senior Scientist).

The Scientist will lead transfer, improvement, optimization and validation of QC assays in the areas of virology and molecular biology for our gene therapy products. The candidate will also manage contract lab development/testing and assure quality of results generated. 

The successful candidate will have a strong analytical background preferably in virology and/or molecular biology.  The candidate will play a key role in trouble shooting, optimizing, and validating QC test methods related to our gene therapy program.

Essential to this role is understanding and experience working in regulated (preferably later stage cGMP) laboratories along with classical and molecular biochemistry. Industry experience in gene therapy or virology and scientific leadership are preferred.

This position offers significant opportunity to develop scientific and managerial skills in a biotechnology environment. The selected candidate will work in a creative, fast-paced environment, interacting with scientists and others from diverse backgrounds.

 The candidate will be required to manage scientific development, implement and maintain plans and strategies to support manufacturing, provide scientific expertise, prepare reports, support regulatory filings and routinely inform project teams and management on progress and problems. 

We are looking for a team player with a strong record of analytical problem solving, method validation, excellent interpersonal skills, and experience in managing and mentoring analysts.    

RESPONSIBILITIES

  • Initiate and execute experiments, either hands on or as a leader and teacher

  • Manage contract lab test method transfers and reviewing data from these labs

  • Optimize and validate purity, strength and potency assays

  • Perform and appropriately document studies under cGMP to support in process, release and stability testing of clinical and eventually commercial gene therapy viral vector substance/product

  • Prepare technical reports, summaries, validation protocols, and validation reports

  • Prepare final reports, study plans, etc., necessary for multiple projects

  • Prepare and deliver presentations of experimental results in internal forums

  • Contribute to project progress within his/her scientific discipline

  • Recommend and defend practices both verbally and in writing as subject matter expert on Quality Control virology and molecular biology testing

  • Contribute to/author regulatory submissions and scientific journal articles

  • Train staff on testing and laboratory systems SOPs 

    EXPERIENCE

    Required Skills:

  • 4-6 years in molecular analytical technique development and validation

  • 4-6 years of experience in cGMP or similarly regulated laboratory.

  • Experience in designing and executing large projects/studies

    Desired Skills:

  • Expertise in regulated laboratory practices and systems (preferably later clinical stage or commercial cGMP).

  • QC procedures and expectations for cultured cell (insect, mammalian) based test methods.

  • Expertise in techniques for titer (eg TCID50, plaque assay, qPCR, expression) of viruses or virus like particles.

  • Expertise in assessments for e.g. empty capsids, aggregates, foreign DNA, proteins, process related impurities etc. (ELISA, HPLC, electrophoresis)

  • Versatility and strength in analytical problem solving may compensate for extensive virology or bioassay expertise.

  • Familiarity with use of a computer (e.g., Windows, Microsoft Word, Excel, and statistical software (such as GraphPad, Minitab or JMP).

  • Good written and verbal communication skills.

  • Strong critical thinking/problem solving skills.

  • Proficient in the use of analytical software such as LIMS, Empower, ChemStation, and/or Softmax Pro.

  • Management experience/ability with laboratory associates or other scientific personel

  • High level of initiative, independence, and ability to work unsupervised.

    EDUCATION

    PhD in a scientific discipline with at least 2-4 years of relevant laboratory experience.

    MS in a scientific discipline with at least 8-10 years of relevant laboratory experience.

    BS in a scientific discipline with at least 12years of relevant laboratory experience.

    EQUIPMENT

    Familiarity with a range of laboratory instruments is preferred (such as qPCR, cell counter, microscope, particle sizing, 96 well plate readers, washers, HPLC, Spectrophotometer).

    CONTACTS

    Reports to Director of QC Viral Vector Analytical group. Interacts with several departments, including but not limited to Manufacturing, Regulatory, Quality Assurance, Maintenance, Engineering, and Process Development.

    SUPERVISOR RESPONSIBILITY

    Dependent on experience and capabilities.