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GMP Manufacturing Director

Tenaya Therapeutics, Inc. Union City, CA

  • Posted: over a month ago
  • Full-Time
Job 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 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

Responsibilities Include

  • Devise with MFG operation strategies and effectively execute clinical and preclinical MFG operations to ensure the qualified process is on time, on budget, and executed with high quality
  • Oversee the cGMP MFG group to ensure high quality standards are maintained and will set expectations on project team performance.
  • Develop and implement Critical Control Parameters to meet the targeted Critical Quality Attributes of AAV-based Gene Therapy DS/DP MFG processes, cGMP facilities and appropriate control strategies
  • Collaborate with other key departments in the company, consistently presenting data trends and results to proactively create appropriate actions as needed.
  • Work with legal to ensure the contracts are executed as per agreement.
  • Manages corresponding CMC aspects of projects and contribute to author CMC sections for regulatory submissions. Works with regulatory affairs team to ensure submission to regulatory authorities is of the highest quality and on schedule every time. Contribute CMC meetings with the FDA and other regulatory agencies.
  • Contribute the audit process of vendors to ensure compliance with all regulatory agencies connected with research, development, manufacturing, packaging and distribution of both development and marketed pharmaceutical products for the company.
  • Ensure effective, rapid and seamless tech transfer from PD/PPO (Pilot Plan Operation) to GMP MFG in close collaboration with PD/AD/QC/PPO departments.
  • Drive for continuous improvement and operational efficiency to eliminate waste and reduce COGS with the MFG operations
  • Oversight and management of the production staff to meet the site schedule and objectives.
  • Management of production area in a safe and compliant manner
  • Set clear objectives, monitor and report on performance of the Operations team in key areas including Quality, Safety, Delivery, and People.
  • Manage product life cycle from transfer of processes from PD/PPO laboratory to internal and external production; includes but is not limited to process maps, risk assessment, safety review, generation of batch records and SOPs, change controls, process controls, process validation
  • Provide technical guidance for complex manufacturing operations, resource planning, staff development and talent and performance management
  • Partner with PD, AD and PPO teams and governance committees as tech ops lead and serve as the liaison to articulate and negotiate CMC strategy with the overall portfolio strategy and filing plans
  • Prepare technical reports, publications, and internal / external presentations
  • Review and approve documents related to GMP operations as requested including process development reports, MBRs/EBRs, and campaign summary report
  • Lead and translate cGMP regulations into GMP MFG risk/benefit analysis with mitigation (and/or derisk) strategies and plans to ensure regulatory compliance and effective workflow
  • Develop budgets, ensure operation within the budget, perform follow-up for pertinent stakeholders and recommend actions to achieve expected results.

Required Education, Skills and Experience

  • Bachelors degrees of Science with at 15+ years of relevant experience in biotechnology/pharmaceutical industry
  • Advanced degree (M.S., Ph.D.) in BioChemical Engineering, Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 10+ years of relevant industry experience is preferred
  • Direct experience with biologics/gene therapy GMP manufacturing, tech transfer, equipment qualification, GMP facility and people management and Process Performance Qualification as well as commercial GMP operation
  • Industry experience with 5+ years in AAV based gene therapy GMP MFG is highly preferred.
  • Prior experience with authoring and review of manufacturing and other CMC regulatory filing sections (e.g., development, batch analysis, annual production report, etc.)
  • Comprehensive knowledge of current Good Manufacturing Practices (cGMPs) and multi-national regulations
  • Familiarity with facility design, construction, commissioning, and qualifications / validations for building facility and end to end manufacturing of GT DS and DP is highly preferred
  • Proven track record of building successful teams and facilitating progressive organizational change for in a fast-growing company.
  • Strong leadership skills and ability to effectively communicate up, down and across the internal and external organizations
  • Ability to effectively prioritize and deliver high-quality results on tight timelines and budget
  • Excellent written, verbal communication and presentation skills
  • Outstanding problem-solving skills including the ability to devise and implement practical solutions to resolve complex issues
  • Ability to travel up to 20% of the time

Benefits

We offer a dynamic start-up environment and a collaborative, passionate team that is focused on a compelling vision and mission.

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, part of a larger cluster of biotech companies, with amenities that include a bowling alley and onsite gym.

Shuttle service to/from Caltrain, BART and the South San Francisco Ferry.

Tenaya is proud to be an equal opportunity workplace. We encourage those from underrepresented communities to apply to our positions.

Our Values:

Tenaya Therapeutics, Inc.

Address

Union City, CA
USA

Industry

Manufacturing

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