SRAI, Tech Ops

The selected candidate will work in the Analytical Sciences group to assist in the advancement of BioMarin’s therapeutics for clinical evaluation and commercialization. The candidate will be responsible for assay development, assay qualification, and characterization testing using routine and non-routine analytical methods. The candidate will apply problem solving techniques to maintain accurate results, promote improvements, and assure a safe, stable, on-target operation with 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

Primary responsibility is to support the Routine Testing group within Analytical Sciences .

• Perform analytical assays for samples within the purview of Routine testing group. including immunoassays, cell-based bioassays, ELISA, chromatography, PCR, and capillary electrophoresis.
• Troubleshoot assay methods and suggest remedies for problems or improvements to the methods.
• Perform peer review of data in electronic lab notebook
• Identify opportunities for improvement in methods and lab techniques
• Support analytical testing of drug substance, drug product, etc. In support of process development, release, and/or stability, according to laboratory procedures, report completion, data entry and other activities.
• Assist in planning and execution of relevant experiments to support development and qualification of analytical assays for gene therapy agents and biologics.
• Oversee supply and equipment inventory to maintain optimal supply levels and ensure equipment repairs and preventative maintenance occur in a timely manner.

Skills

Required Skills:

• In-depth technical understanding of all aspects of analytical testing, GxP requirements, qualifications and transfers.
• Ability to independently troubleshoot issues, ideate and develop insights to 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 teamsFamiliar with use of statistical data systems, 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.

• Experience in method development, qualification, and transfer to/from other laboratories such as development, quality control.
• Knowledge of biopharmaceutical process development is a plus.
• Must have a basic understanding of AAV-based products and working knowledge of lot release and stability requirements (specifications, stability protocols, laboratory investigation processes, etc.) .
• Experience with mammalian cell culture is a plus
• Experience with automation is a plus
• Experience working in a cross-functional environment.
• Good understanding of root cause analysis methodology.
• 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.

Education

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

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.