Scientist 2 / Senior Scientist, QC Analytical Technologies

Location:  Novato, California Category: Quality

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.   

BioMarin is seeking a Molecular Biology or Biochemistry Scientist within the QC Analytical Technologies group (Scientist 2 / Senior Scientist). The candidate will oversee special studies and manufacturing support for process optimization, process qualification, and deviation investigations. The scientist will potentially supervise up to five analysts.   Activities include defining and executing scientific plans, tabulating and processing process and analytical data, and working with other scientists and team members. The Scientist 2 / Senior Scientist candidate will also assist with regulatory filings and serves as the QC representative for inter-departmental meetings.

The candidate will play a key role in product development and manufacture. Essential to this role is a strong knowledge base and broad expertise in biochemistry or molecular biology and the ability to lead and mentor scientific staff and collaborate with cross functional team members to execute product development.  The candidate will be required to manage scientific development, implement and maintain plans and strategies to support manufacturing, provide scientific expertise, prepare reports and keep upper-level management informed of progress and problems. Previous experience with potency and purity test methods for gene therapy or protein therapeutics and cell culture is highly desirable.  The candidate must have five years of experience leading teams and five years of experience in a GMP environment.

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 or individuals from diverse backgrounds.  We are looking for a team player with a record of contribution to process optimization/validation, excellent interpersonal skills, and experience in managing and mentoring analysts.   We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Education:

PhD in a scientific discipline with at least 5 years of relevant laboratory experience.
MS in a scientific discipline with at least 10 years of relevant laboratory experience.
BS in a scientific discipline with at least 14 years of relevant laboratory experience.

Experience:

  • Expert in growth of multiple human, animal, and insect cell lines is desirable.
  • Familiarity with use of a computer (e.g., Proficient in Windows, Microsoft Word, Excel, and statistical software (such as GraphPad or Minitab).
  • Familiarity with a wide range of analytical technologies such as HPLC, ELISA, and/or bioassays.
  • Good written and verbal skills.
  • Strong critical thinking/problem solving skills.
  • Proficient in the use of analytical software such as LIMS, Empower, ChemStation, and/or Softmax Pro.
  • Experience in designing and executing large projects/studies is essential.
  • Experience with or knowledge of Quality Control or GXP is required.
  • High level of initiative, independence, and ability to work unsupervised.

Responsibilities:

  • Oversee assigned investigations and deviations
  • Serve as SME for QC test methods
  • Prepare technical reports, summaries, and presentations as needed.
  • Prepare study plans as necessary for multiple projects
  • Prepare and deliver presentations of experimental results and investigations in internal forums
  • Contribute to project progress within his/her scientific discipline
  • Contribute to/author regulatory submissions
  • Train department staff on testing and laboratory systems SOPs 

~BIO