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Manager, Validation

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Company :
Tenaya Therapeutics, Inc.

Location :
Union City, California

Expiry Date :
Sat, 15 May 2021 23:59:59 GMT

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Description :
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 [ and follow us on LinkedIn [

Diversity & Inclusion is a core Value for Tenaya Therapeutics and we encourage those from under-represented communities to apply.

The Role

The Validation Manager will lead and oversee and/or perform the qualification of Equipment, Utilities, Facilities. The Validation Manager will work closely with Manufacturing, QC, Engineering and Facilities group to ensure compliance of cGMP systems

Responsibilities include the development of commissioning and validation standards, process qualification strategy and framework, continuous process verification (CPV) strategy and consistent implementation, ensuring that these standards are met in the quality system. The individual will partner with senior management and stakeholders to develop a validation strategy and systems appropriate for preclinical, clinical, and commercial stages of production.

The successful candidate will also be responsible for developing a tailored approach for each project they are assigned including; assessing vendor validation packages, performing gap analysis to User Requirements, development of Commissioning and Qualification Plans, developing protocols using a risk based approach that complies with company policies and procedures, and completing trace matrices. The job includes qualification and validation of equipment, facilities, utilities, and manufacturing processes.

Specific responsibilities include:

* Oversee development and implementation of validation strategies, policies, protocols, and other documentation for cGMP systems including:

* Manufacturing equipment
* Manufacturing Cleanrooms
* Utilities
* Quality Control Equipment

* Develop and execute validation plans and protocols to demonstrate systems are meeting design and functional requirements using risk based approach (FMEA, PHA, etc)
* Compile data and results into summary and final reports
* Review project documentation (URS, FRS, Technical Specifications, Functional Specifications)
* Perform risk assessments to confirm safe / compliant designs, recommend additional controls as required
* Self-execute or manage the authoring of commissioning, qualification, and validation plans
* Self-execute or manage the authoring and execution of validation protocols
* Self-execute or manage the authoring of validation summary reports and requirement trace matrices
* Hire and manage commissioning contractors in the planning and execution of validation activities as required
* Develop, organize, and execute the Validation Maintenance program
* Evaluate and performing periodic reviews of validated systems to ensure validated state in maintained
* As a subject matter expert, represent commissioning and validation activities in discussions and communications with regulatory agencies
* Interface with other departments to ensure achievement of objectives relating to validation to ensure a compliant manufacturing environment

Requirements

* Minimum B.S. degree in Engineering, Science or related technical field
* A minimum of 7 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish
* Ability to read/interpret engineering drawings and design documents
* In-depth knowledge of FDA regulations particularly 21 CFR part 11, 210, 211
* Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements
* Proven ability to make risk-based decisions in a complex/dynamic environment in a timely manner.
* 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

Benefits

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.