Manufacturing Supervisor

Job Locations US-CA-Thousand Oaks
ID
2020-1306
Category
Manufacturing
Type
Regular Full-Time

Job Description

The Manufacturing Supervisor works as part of the Manufacturing team to deliver on the team goals to generate high quality materials that can be used both in the clinic as well as commercial.  This position will contribute to the successful delivery of released product in support of clinical trials and commercial requirements.  The Manufacturing Supervisor will work in different activities including manufacturing processes, facility cleaning, document review, inventory control and materials management.  The position will also provide manufacturing processing input for the design and operation of computer systems (MES, ERP, LIMS, QMS, EMS).  The candidate will also understand the requirements needed to meet quality and regulatory compliance in the manufacturing environment.

Work Location: Thousand Oaks, CA

Reports to: Director, Manufacturing

Primary Responsibilities

  • Support production in an aseptic environment
  • Provide oversight to manufacturing operations personnel to ensure adherence to production schedule and GMP compliance
  • Assists in the day to day manufacturing operations and identifies improvement opportunities.
  • Writes manufacturing documents pertaining to the manufacture of the company’s cellular therapies
  • Works with the quality group and contract manufacturing organization to support regulatory filings for the various clinical programs.
  • Reviews completed batch records and initiates deviations when appropriate.
  • Supports critical investigations into the manufacturing process operations
  • Performs scheduling of operations
  • Supports development, and technology transfer activities into manufacturing in the execution of change control, functional testing, and/or commissioning and qualification.
  • Assists in the establishment of systems as they pertain to the new manufacturing facility.
  • Creates, updates, and maintains manufacturing SOP’s to ensure they are in-line with the current process steps.

Travel Requirements:  (10%)

Physical Requirements:  
Subject to extended periods of sitting and/or standing in a clean room environment (ISO 7 or 5).  Work is generally performed in an office, manufacturing clean room or clinical environment.

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Qualifications

Education and Professional Experience:

  • BS degree in field of biochemical/chemical engineering or life science
  • 5+ years related work experience
  • Must be knowledgeable and worked in biotech manufacturing related industry.
  • Demonstrated understanding of cGMP execution.
  • Supervise personnel in a manufacturing environment.

Position Requirements: 

  • Strong communication skills (e.g., clear and concise), both written and verbal and a team player.
  • Specific experience with ERP, MES, QMS, LIMS is a plus.
  • Previous experience in manufacturing or operations environment.
  • Experience with computer and documentation systems.
  • Good decision making with strong judgment through collaboration and consideration of others point-of-view.
  • Ability to understand manufacturing process and equipment related engineering tools, such as process flow diagrams, and/or engineering specifications/requirements.
  • Experience with automation systems and equipment used in cell therapy manufacturing is a plus.
  • Understanding of cGMP for cell therapy manufacturing.
  • Flexibility to work on any shift required to accommodate the business needs.
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.

More about Atara Bio

We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We’re named after Atara Ciechanover who suffered from cancer before passing away. 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 350+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. 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 in Thousand Oaks, California.

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.”

 

Visit www.atarabio.com 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.
 
 

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