Scientist 1 - Analytical Sciences compliance for early stage clinical programs
Novato, CA
WHO WE ARE For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard \u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. 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 Research 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 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.\u00A0SUMMARYThe Analytical Sciences department at **MEMBERS ONLY**SIGN UP NOW*** is seeking a Scientist 1 to support compliance for early-stage clinical programs. This is a central role in the Routine Testing and Compliance team within Analytical Sciences, a team responsible for lot release and stability testing for early-stage gene therapy and recombinant biologics clinical programs, support of process development routine testing, and support of quality systems within Analytical Sciences.\u00A0 The primary set of responsibilities will be designing and implementing Quality Management Systems (QMS) and driving a quality mindset for the Analytical Sciences department, all with a phase-appropriate GxP focus for early-stage clinical programs. Additionally, the Scientist will support non-GxP compliance activities both within Analytical Sciences, as well with our Technical Development process development partners. The selected candidate should possess excellent organizational, analytical and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment.\u00A0RESPONSIBILITIES Design and implement phase-appropriate Quality Management Systems (QMS) within the Analytical Sciences group Support documentation and implementation of phase-appropriate procedures for GLP test article characterization and GMP release testing for early-stage programs Support compliance oversight of Analytical Sciences laboratory equipment, coordinating qualification processes and maintaining GxP readiness Drive quality mindset for the Analytical Sciences department (GxP and non-GxP activities) by developing training tools and monitoring quality practices in the group Drive initiatives with Technical Development partner teams (Drug Substance Technologies (DST), Chemical, Drug Product and Device Technologies (CPDT)) to drive a quality mindset for non-GxP activities, supporting implementation of projects such as phase-appropriate documentation, data integrity, and training Support data review for GxP testing and external requests from Quality and Regulatory partners Perform and document laboratory investigations and support deviations and CAPAs Guide implementation of improvement concepts for the further development of procedures or laboratory systems Support monitoring of routine method performance by data trending, identifying recurring issues and opportunities for improvement Track progress against project timelines, generate regular status updates and communicate progress, resourcing needs and issues to leadership Document findings electronically in an accessible manner for inspections. Attend of all team meetings with some facilitation of discussions, providing focus and accounting for the impact of department initiatives to the greater organizationEXPERIENCERequired Skills: Detailed knowledge of Quality Management Systems, current Good Manufacturing Practices, and phase-appropriate Quality principles and compliance requirements Understanding of GxP equipment qualification Ability to collaborate with QA to initiate and investigate deviations from procedures, and support reasoning for conclusions Strong written communication skills, with the ability to author and review relevant documentation (methods, protocols, investigations, reports) Strong project management skills Working knowledge of statistics along with advanced software expertise, such as with JMP Exceptional interpersonal skills and experience contributing to productive teams and fostering cross functional relationships Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment Must have a quality service attitude and focus, exhibit flexibility and willingness to work necessary hours to meet production or laboratory process requirementsDesired Skills: Experience in gene therapy analytical testing or method developmentEDUCATIONMaster\u2019s degree in Biology, Chemistry, Molecular Biology or related field with 5 years of relevant industry experience, or bachelor\u2019s degree with 8 years of relevant industry experience CONTACTSWill report to the Director of the Routine Testing and Compliance team within Analytical SciencesSUPERVISOR RESPONSIBILITYThis is an individual contributor role\u00A0PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for 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.
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