Director of Sterility Assurance
Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: May 3, 2021
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
- 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,
- 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
- Audit (or support audits of) site sterility processes and
suppliers providing sterile materials or microbiological services
- 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
- Report status of, and promote, Sterility Assurance to Senior
- 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,
- 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
- Direct experience of QA oversight of sterility assurance
programs, aseptic programs, and microbial monitoring of aseptic
- 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
- Experience interacting with regulatory authorities during
- 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
Our vision - "T-Cell Immunotherapy for every patient, any
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
www.atarabio.com/careers 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
Didn't find what you're looking for? Search again!