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Job Title
SRAII, Tech Ops
Company
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Job Description
Sr. Research Associate II, Tech OpsBioMarin 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\u2019s 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. The Analytical Sciences department supports all assay needs in Tech Ops. Our 50 scientists and associates are experts in analytics of small molecules, peptides, proteins/enzymes, and gene therapy agents. We develop assays to follow the quality attributes of our products, support IND and BLA applications, and assess the capability of our production processes. We develop release assays and are responsible for lot release and formal stability testing for early-stage clinical programs (tox, development, GMP lots), and support assay transfer to Quality for late-stage programs. We are also instrumental in time-critical analysis support to Manufacturing as needed. Come join our team and make a meaningful impact on patients\u2019 lives.JOB DESCRIPTIONThe selected candidate will work in the Analytical Sciences group to assist in the advancement of BioMarin\u2019s 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.RESPONSIBILITIESPrimary 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 notebookIdentify opportunities for improvement in methods and lab techniquesSupport 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\u00A0gene therapy agents and\u00A0biologics.Oversee supply and equipment inventory to maintain optimal supply levels and ensure equipment repairs and preventative maintenance occur in a timely manner.SkillsRequired 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 \u201Cright-the-first-time\u2019 approachExcellent 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 departmentAbility 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.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 plusExperience with automation is a plusExperience 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.\u00A0 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.\u00A0\u00A0 Desktop or laptop computer work is also a major component of the job.EducationBachelor\u2019s Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 8 years of experience in a Biologics or Pharmaceutical environment.Master\u2019s Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with 6 years of experience in a Biologics or Pharmaceutical environment.\u00A0PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated\u00A0for COVID-19. 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.\u00A0
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Location
Novato, CA
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