- Job Type: Full-Time
- Function: Manufacturing
- Industry: Biotechnology
- Post Date: 02/06/2023
- Website: tenayatherapeutics.com
- Company Address: 171 Oyster Point Blvd, Suite 500, South San Francisco, California , 94080
- Salary Range: $50,000 - $150,000
About Tenaya TherapeuticsCurative gene therapies and cell regeneration treatments for heart disease
Tenaya 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 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.
As 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
- Drug Substance formulation
- Drug product fill
- 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 pressure