We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options to combat cancer and other serious illnesses. Our research is based on technology that enables the ability to harness and augment the immune system to stem disease. Our goal is to help patients, such as Atara Ciechanover, our company’s namesake, who suffered from cancer before passing away in 2012. We aim to empower patients to fight their illnesses with innovative treatment options.
This role works as part of a team to deliver high quality materials that can be used both in clinic applications as well as commercial. The primary focus is cellular therapeutic manufacturing during process transfers, routine production, and technology improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production. The manufacturing associate supports production in an aseptic environment during day shift hours.
Reports to: Supervisor, Manufacturing
Location : Westlake Village (Northwest Los Angeles) to transfer to Thousand Oaks
Completes documentation required by process transfer protocols, validation protocols, SOP’s and Batch Records.
Works as part of a team to execute GMP production alongside quality and process development teams.
Aseptic/ sterile techniques and prior experience working in a cGMP environment.
Assists in the development of manufacturing batch records, identify and investigate deviations and implement change controls.
Successfully troubleshoots processing and equipment issues.
Reports issues accurately and promptly.
Cleans manufacturing space.
Performs kitting operations in adherence to batch records and SOPs.
Assists in the day to day manufacturing operations, and identifies improvement opportunities.
Reviews completed batch records.
Assists in the establishment of systems as they pertain to the new manufacturing facility.
Travel: Travel required (up to 5%).
Subject to extended periods of sitting and/or standing in a clean room environment. Work is generally performed in an office, manufacturing clean room or controlled warehouse environment. Can lift up to 30 lbs.
Strong communication skills (e.g., clear and concise), both written and verbal and a team player.
Aseptic processing in ISO 5 (Grade A) biosafety cabinets.
Universal precautions for handling human derived materials in BSL-2 containment areas.
Specific experience with MES, QMS, LIMS is a plus.
Previous experience in manufacturing or operations environment.
Cell expansion using incubators and single use bioreactors.
Cell washing and cell separation techniques.
Experience with automation systems and equipment used in cell therapy manufacturing is a plus.
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.
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.
Education and Professional Experience
Bachelor’s degree and 1-3+ years of Manufacturing and Operations experience.
Aseptic technique experience.
Must be knowledgeable about the biotech manufacturing industry
More About Atara Bio
We are a four-year-old approximately 100+ person publicly traded ( NASDAQ exchange symbol ATRA ) clinical-stage biopharmaceutical company focused on developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation. We are co-located by design in Westlake Village, CA (northwest LA) and South San Francisco, CA, with a process development lab in the Denver, CO area at the Fitzsimons Innovation Center and an office in New York City.
We are concentrating on developing allogeneic or third-party derived antigen-specific T-cells. T-cells are a type of white blood cell. Cytotoxic T-cells, otherwise known as cytotoxic T lymphocytes, or CTLs, can mount an immune response against an antigen or antigens to combat viral infection or disease.
Our most advanced T-cell product candidate, ATA129 (previously referred to as EBV-CTL), which is a third-party derived Epstein-Barr virus CTL, is currently being investigated for the treatment of Epstein-Barr virus, or EBV, associated post-transplant lymphoproliferative disorder, or EBV-PTLD. In immunocompromised patients, EBV causes lymphomas and other lymphoproliferative disorders, collectively called EBV-PTLD. EBV-PTLD most commonly affects patients after hematopoietic cell transplant, or HCT, or after solid organ transplant, or SOT.
In December 2016, we announced that we had reached agreement with the U.S. Food and Drug Administration, or FDA, on the designs of two Phase 3 trials for ATA129 intended to support approval in two separate indications, the treatment of rituximab-refractory EBV-PTLD after HCT and after SOT.
In February 2015, the FDA granted breakthrough therapy designation for ATA129 in the treatment of rituximab-refractory EBV-PTLD after HCT. Breakthrough therapy designation is an FDA process designed to accelerate the development and review of drugs intended to treat a serious condition when early trials show that the drug may be substantially better than current treatment. In February 2016, the FDA granted orphan drug designation for ATA129 for the treatment of patients with EBV-PTLD after HCT or SOT.
We are also pursing marketing approval of ATA129 in the European Union, or EU. In March 2016, the European Medicines Agency, or EMA, issued a positive opinion for orphan drug designation for ATA129 for the treatment of patients with EBV-PTLD. In October 2016, the EMA Committee for Medicinal Products for Human Use, or CHMP, and Committee for Advanced Therapies, or CAT, granted access to the EMA’s newly established Priority Medicines, or PRIME, regulatory initiative for ATA129 for the treatment of patients with rituximab refractory EBV-PTLD following HCT. PRIME provides early enhanced regulatory support to facilitate regulatory applications and accelerate the review of medicines that address a high unmet need.
In January 2017, we announced that pursuant to parallel scientific advice from the EMA’s Scientific Advice Working Group and several national Health Technology Assessment, or HTA, agencies in the EU, in 2018 we plan to submit an application for Conditional Marketing Authorization, or CMA, of ATA129 in the treatment of patients with rituximab refractory EBV-PTLD following HCT.
In addition to ATA 129, Atara Bio is in the process of bringing forward three other t-cell product candidates (ATA188, ATA520, ATA230 for indications ranging from Multiple Myeloma to Nasopharyngeal carcinoma to Multiple Sclerosis) that are in various trials.
Working at Atara Bio
People at Atara Bio are high integrity, get-it-done, roll-up-your-sleeves types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. With many accomplished people at Atara Bio, we expect humility, flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a responsibility to teach and to learn from each other.
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.