Team Lead, Downstream Manufacturing
Company: Tenaya Therapeutics, Inc.
Location: Union City
Posted on: April 4, 2021
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
- 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
- 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
- Participate in the execution of small-scale and large-scale
- 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
- 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
- Basic understanding of upstream/downstream cell culture and/or
- 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
- Able to work with cross-functional areas such as quality and
- 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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