Associate Director/Director Cell Therapy CMC - Westlake Village, CA | Biospace
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Associate Director/Director Cell Therapy CMC

Atara Biotherapeutics, Inc.

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Location:
Westlake Village, CA
Posted Date:
6/2/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Cell, Director,

Job Description


The Assoc. Dir./Dir. Cell therapy CMC is responsible for leading CMC activities for Atara’s allogeneic cytotoxic T cell products under clinical co-development with Atara’s Australian partner, QIMR.  Responsibilities include establishing and managing work plans to achieve clinical manufacturing goals for QIMR-partnered T cell products, assuring processes and assays are developed in compliance with FDA regulations and those of other regulatory agencies, authoring CMC sections of INDs and other filing, and maintaining a constructive and cooperative relationship with QIMR colleagues.  The role has broad experience across CMC functions including process development, manufacturing, assay development and QC, and has substantially contributed to authoring CMC sections of regulatory filings.  Importantly, the AsDir/Dir will have experience developing cell therapies.  The successful candidate must have successfully demonstrated technical proficiency, scientific creativity, initiative, independent thinking and collaboration with others.

Reports to: Sr. Director, Cell Therapy CMC

Location: Westlake Village (northwest Los Angeles area)

Primary Responsibilities

•   Establish project plans and timelines for all CMC aspects of multiple T cell therapy development projects, and manage activities through to punctually achieving goals.
•   Provide technical and GMP guidance to members of the QIMR team across process development, manufacturing, assay development, quality control, validation and supply chain disciplines.
•   Represent CMC functions for review and approval of cGMP documentation.
•   Collaborate with Atara Quality and Regulatory functions as well as functional leads at QIMR to maintain alignment of goals and to navigate project obstacles.
•   Author and assemble CMC sections of regulatory filing including INDs and amendments and equivalent documents for ex-US filings.
•   May lead project sub-teams and working groups.
•   Periodically travel to Australia to collaborate face-to-face with QIMR colleagues.
•   May hire, supervise and mentor junior staff.

Requirements


•   Degree in a biological science with 12-18 years of relevant experience in biologics development including cell therapy development: PhD (preferred) with 12-16 years of relevant experience; or a MS with 14-18 years of industrial experience, or BS with 16+ years of industrial experience.
•   Fundamental knowledge in cell biology, immunology, cell culture and cell cryopreservation principles.
•   Breadth of knowledge across cell therapy processing technologies, cell characterization methods, method development, cGMP, validation, Quality Systems and regulatory requirements.
•   Demonstrated skills in designing, executing and interpreting experiments.
•   Experience authoring CMC sections of regulatory documents.

Travel: Travel required (up to 25%).

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.