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Director of Sterility Assurance

Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: May 3, 2021

Job Description:

Job Description

The Quality Director of Sterility Assurance will be responsible for championing Sterility Assurance principles and serve as the Quality technical leader in the areas of sterilization, aseptic processing, and microbiology. The role will be accountable for assuring quality assurance oversight of Sterility Assurance, Aseptic Process Program, Environmental Monitoring and Microbial Control Policies for the Cell Therapy and/or Viral Therapy Operations. The individual is expected to interact with Cell and Viral Therapy Operations Management, QC and QA leadership. Primary responsibility is to maintain sterility assurance of aseptically manufactured sterile drug products and viral vector products. This position requires in-depth understanding of cGMP regulations and guidelines related to sterility assurance and proven applications in an aseptic/sterile production environment.

Reports to: Sr. Director, Quality Systems & Compliance

Location: Thousand Oaks, CA

Travel: 15% up to as business needs based on location


  • Responsible for defining company policy and developing company strategies with respect to cleanliness, sterilization, clean rooms, aseptic practices and related areas.
  • Establish and maintain the contamination control strategy and oversee aseptic programs
  • Responsible for compliance to applicable Quality Regulations, standards, and other regional requirements.
  • Provide input in the design of manufacturing processes, controlled environments, and packaging from a microbiological standpoint.
  • Generate and maintain the contamination control strategy
  • Promote understanding of and compliance to Sterility Assurance related regulations such as the FDA's aseptic processing guide and EU Annex 1
  • Lead and/or support major investigations related to sterility assurance events (i.e. Adverse EM trends, media fill failures, etc.)
  • Review & approve any major/critical deviation, change proposal or other quality records with Sterility Assurance impact
  • Ensure that suitable aseptic programs (including training, oversight, and monitoring) are in place and effective and that all sterilization processes are appropriately managed.
  • Maintain aseptic and sterility assurance practices in alignment with current and future regulatory requirements and expectations. Conduct risk assessments, as needed, to ensure ongoing compliance.
  • Audit (or support audits of) site sterility processes and suppliers providing sterile materials or microbiological services (as required)
  • Act as sterility assurance SME with external regulators, clients, company management in addition to acting as SME for new product introductions and applicable capital projects.
  • Generate technical reports, as required, to support business needs
  • Report status of, and promote, Sterility Assurance to Senior Leadership


  • BS degree in life sciences, business, or related field (advanced degree preferred)
  • 10 years of experience in biopharmaceutical industry (prefer experiences in both large and small company environments)
  • QC Microbiology experience and/or education preferred
  • Sterile supplier auditing experience, desired
  • Experience in supplier quality and management of sterile processing suppliers, preferred.
  • Experience of developing and influencing business strategy, desired
  • Experience in Sterility Assurance validation and product validation using varying sterilization methods.
  • Must have a high technical knowledge of Sterility Assurance & Cleanroom standards, with demonstrated experience of implementation responsibility.
  • Direct experience of QA oversight of sterility assurance programs, aseptic programs, and microbial monitoring of aseptic manufacturing areas.
  • Strong working knowledge of worldwide regulations related to aseptic practices and sterility assurance and the ability to interpret these requirements into execution compliance.
  • Solid understanding of the principles of sterile manufacturing and Quality Systems required for a sterile manufacturing facility.
  • Experience interacting with regulatory authorities during regulatory inspections.
  • Ability to self-manage and work effectively with internal & external stakeholders and parties, including regulatory agencies, with minimal oversight.
  • Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks.
  • Must be a strong leader and cross functional team player with ability to work effectively in a fast-paced matrixed environment while managing multiple projects simultaneously
  • Must possess excellent verbal and written communication skills; good interpersonal skills.
  • Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)

More about Atara Bio

We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.

We're proud of our team of 425+ Atarians co-located by design in 4 different locations including South San Francisco (corporate headquarters), Thousand Oaks (R&D and manufacturing headquarters), Zug, Switzerland (european headquarters) and a R&D site in the Denver, Colorado area. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility. Our mission - "Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence."

Our vision - "T-Cell Immunotherapy for every patient, any time."

Atara offers a competitive benefits packages that includes medical/dental/vision benefits, life and disability, retirement and stock program, as well as a generous paid time off and wellness plan that supports the well-being of our staff. Visit to learn more.

Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual's association with a member of a protected group or connection to an organization or group related to a protected group.We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.

Keywords: Atara Biotherapeutics, Thousand Oaks , Director of Sterility Assurance, Other , Thousand Oaks, California

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