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Team Lead, Downstream Manufacturing

Company: Tenaya Therapeutics, Inc.
Location: Union City
Posted on: April 4, 2021

Job Description:

CMC & Manufacturing Union City, California, United States Full time M.22 Tenaya Therapeutics is a preclinical-stage, Series C, privately held biopharmaceutical company that is shaping the future of heart disease treatment driven by a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of disease. Tenaya is developing therapies for rare genetic disorders as well as for more prevalent heart conditions through three platforms: Gene Therapy, Regeneration and Precision Medicine. Founded by leading cardiology researchers at the Gladstone Institutes and UT Southwestern, Tenaya is backed by a top-tier syndicate of investors, including The Column Group, Casdin Capital, RA Capital, RTW, Fidelity, T Rowe Price, GV and others. Tenaya Therapeutics currently has 75+ full-time employees (not including consultants) and is headquartered in South San Francisco, California, USA. For more information, please visit www.TenayaTherapeutics.com and follow us on LinkedIn. Diversity & Inclusion is a core Value for Tenaya Therapeutics and we encourage those from under-represented communities to apply. Requirements The Role As part of Tenaya's manufacturing team, the position is responsible for leading the downstream manufacturing processes for clinical and ultimately commercial stage for our proprietary recombinant adeno-associated virus (AAV) gene delivery products. Responsibilities include small and largescale purifications using a range of chromatography techniques, analysis, interpretation, and documentation of data. The successful candidate is expected to lead a team of associates to execute and continuously improve the manufacturing process, provide insights back to the process development group, develop and maintain a production schedule to meet departmental and organizational goals, and to communicate plans and results to Technical Operations management. Specific responsibilities include:

  • Manage production operations and process technology transfer within the downstream operational area which includes the process, people, equipment, and documents, to ensure safe and quality drug substance is produced to support clinical trials.
  • Performs small and large scale purifications using a range of chromatography, centrifugation, as well as filtration methods as needed.
  • Handles troubleshooting of manufacturing equipment and control systems within assigned operational area. Escalates issues to facilities and Engineering as necessary.
  • Participates in the design and qualification of new equipment or system improvements, changes, or upgrades within assigned operational area
  • Participate in the execution of small-scale and large-scale validation.
  • Responsible for maintaining consistent product supply.
  • Cross functional collaboration with Quality Unit and Engineering for assigned operational area.
  • Require enthusiastic attention to detail and keen ability to reliably produce viral vectors in a cross functional team in compliance with various regulatory guidance.
  • Open minded attitude that start-up team environments require an assortment of skill and a high level of commitment
  • Test the feasibility of new manufacturing processes.
  • Maintain the cleanliness of the manufacturing area
  • Manages a team of associates; Grows, develops, and promotes a collaborative culture that aligns with corporate culture. Required Education, Skills and Experience
    • Bachelor's degree in Biology, Biochemistry, or engineering related discipline with 5-7 years of relevant experience in a cGMP Clinical, Commercial Manufacturing setting.
    • Experience with the production of viral vectors for cell or gene therapy applications.
    • Hands on experience with AKTA system and UNICORE software is strongly preferred
    • Experience of protein purification techniques including TFF, chromatography, and filtration
    • Excellent aseptic techniques
    • Demonstrated ability to identify process or protocol bottlenecks and variability to troubleshoot in collaboration with supervisor
    • Basic understanding of upstream/downstream cell culture and/or fermentation.
    • Experienced with electronic systems including QMS, Documentation, LIMS, ERP, Building automation system, MMS/Maintenance, Process Automation systems, and other business systems (Microsoft Word, Excel, etc.)
    • Proven ability to make risk-based decisions in a complex/dynamic environment in a timely manner.
    • Experienced in authoring cGMP documentation including SOPs and Batch records.
    • Able to work with cross-functional areas such as quality and engineering.
    • Ability to flex and quickly adapt to changing environment and competing priorities and deadlines under pressure. We have a passionate and collaborative team that is focused on a compelling mission in a dynamic start-up environment. We value diversity. We offer competitive salary and stock options. Excellent medical and non-medical benefits. Paid vacation, sick time and holidays. State-of-the-art, built-to-suit office and lab space overlooking the bay. Part of a larger cluster of biotech companies, with amenities that include an onsite gym, restaurant, cafe and bowling alley. Shuttle service to/from Caltrain, BART and the South San Francisco Ferry. Tenaya Therapeutics, Inc. does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.

Keywords: Tenaya Therapeutics, Inc., Union City , Team Lead, Downstream Manufacturing, Other , Union City, California

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