Manufacturing Associate (contract position)
Company: Tenaya Therapeutics, Inc.
Location: Union City
Posted on: March 19, 2023
Job Description:
Manufacturing Associate (Contract Role)Union City,
CADescriptionTenaya Therapeutics is a preclinical-stage
biopharmaceutical company 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
and more prevalent heart conditions through three platforms: Gene
Therapy, Regeneration, and Precision Medicine.Tenaya Therapeutics
currently has 140+ full-time employees and is headquartered in
South San Francisco, California, USA. For more information, please
visit and follow us on LinkedIn.Diversity & Inclusion is a core
Value for Tenaya Therapeutics, and we encourage those from
under-represented communities to apply.RequirementsThe RoleAs part
of Tenaya's manufacturing team, the position is responsible for
executing the upstream and/or downstream manufacturing processes
for clinical stage for our proprietary recombinant adeno-associated
virus (AAV) gene delivery products at Tenaya's Union City plant.
This is a contract role.Responsibilities include small and
large-scale cell culture and/or purification using a range of
recombinant cell expression systems (from seed train shaker flasks
through production bioreactors), chromatography techniques, along
with analysis, interpretation, and documentation of data output
from the processes. The successful candidate is expected to execute
the manufacturing process unit operations per a production schedule
to meet forecasted product demands. Specific responsibilities
include:
- Working in a GMP manufacturing controlled environment, donning
plant uniforms and shoes, and cleanroom gowning as defined in
written procedures.
- Writing SOPs, batch records, and other GMP-controlled
documents, including drafting, reviewing, and routing for raw
material/consumable specifications approval.
- Order materials/consumables to ensure they are available before
the production campaign.
- Assisting in executing IOQs for the onboarding of
equipment.
- Maintaining the production area in a clean and tidy
manner.
- Participating in the process deviation initiation,
investigation, and closure.
- Participation in change control activities.
- Ensuring training records are up to date with current effective
procedures.
- Operating equipment per approved procedures in a safe
manner.
- Executing various phases of recombinantly expressed gene
therapy processes as defined in GMP procedures. Technical areas of
responsibility may include the following areas:
- Buffer preparation.
- Seed train cell expansion
- Production cell culture of the cell host vector as well as
viral vectors.
- Production cell host infection, viral inactivation, lysis, and
harvest filtration
- Chromatography
- Drug Substance formulation
- Drug product fill
- Labeling
- Media fills
- Hands on assistance and training with the Product Development
team.
- Responsible for maintaining consistent product supply.
- 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. Required
Education, Skills and Experience (job level commensurate with
experience)
- Bachelor's degree in Biology, Biochemistry, or engineering
related discipline with 0-4 years of relevant experience in a cGMP
Clinical, Commercial Manufacturing setting.
- Hands on experience with AKTA system and UNICORN software is
strongly preferred.
- Experience in cell culture and/or protein purification
techniques including TFF, chromatography, and filtration.
- Excellent aseptic technique.
- Basic understanding of upstream/downstream production.
- Experienced with electronic systems including QMS,
Documentation, Process Automation systems, and other business
systems (Microsoft Word, Excel, etc.)
- Experience in authoring cGMP documentation including SOPs and
Batch records a plus.
- Able to work with cross-functional areas such as quality,
engineering, and process development.
- Ability to flex and quickly adapt to changing environment and
competing priorities and deadlines under pressur
Keywords: Tenaya Therapeutics, Inc., Union City , Manufacturing Associate (contract position), Other , Union City, California
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