Quality Engineer/Validation Manager, Site QA - Westlake Village, CA | Biospace
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Quality Engineer/Validation Manager, Site QA

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:
Engineering, QA, Quality, Quality Assurance,

Job Description


This role supports the Cellular Therapy GMP quality programs at Atara as we start down the road to product commercialization. The key initial charter for the role is to ensure that a new GMP manufacturing facility is designed, constructed and qualified per regulator and Atara GMP compliance expectations.  This position will also oversee on-going quality systems metrics programs and provide QA Validation support to plant operations.

Reports to: Senior Director Quality Assurance

Location: Westlake Village, CA (northwest Los Angeles)

•   Key member of team for GMP validation role in the design, construction and qualification of a new GMP manufacturing and testing facility.
•   Leads GMP validation oversight role regarding systems related to GMP manufacturing and testing; including facility, utilities, computers, process, equipment and instruments.
•   Facilitates “quality by design” initiatives during execution of related validation activities, including process development studies in support of process validation.
•   Provides validation competency to support various quality systems including:
•   Change Control.
•   Non-conforming material investigations, including root cause analysis to address problems and identify trends.
•   Production process data trend analysis.
•   Product complaint investigation.
•   Development & implementation of product & process quality plans, & inspection & testing strategies.
•   Development & implementation of quality programs.
•   Complete day-to-day operations of the Corrective & Preventive Actions system.
•   Monitors supplier quality and works directly with suppliers to improve performance.
•   Trains personnel in Validation procedures.
•   Acts a Continuous Improvement Agent.
•   Reviews and approves controlled documents as required, including protocols, reports, document changes, etc.
•   Works collaboratively with both internal and external clients/collaborators and with regulatory agencies to anticipate and resolve quality issues as well as maintain GMP compliance. Provides validation input into third-party investigations and deviations.
•   Supports a positive work environment and works in a fashion consistent with Atara Bio values.
•   Supports other GXP functions as required.

Travel: Travel may be required (up to 20%).

Requirements


•   Solid understanding of validation systems and continuous process improvement principles including global cGMP/GTP requirements, and other relevant regulations and guidance to assure quality products.
•   Expertise in the cGMP/GTP requirements pertaining to manufacturing operations in the United States and EU. Experience with the application of global good manufacturing practices and regulatory requirements is preferred.
•   At least 8 years of experience in cGMP/GTP Quality operations, of which at least 5 years’ experience supporting commercial phase cGMP Quality operations, and at least five (5) in a leadership role. At least 2 years of experience in clinical product GMP Quality operations a plus.
•   Experience in a QA role in the management of large facility construction/remodeling projects.
•   Minimum of a BS/BA in natural sciences. Preferred B.S. in Engineering. Preferred experience in managing process data collection and statistical analysis.
•   Experience with cGMP, manufacturing, and testing requirements as they relate to biologics, experience with cell therapy processes a plus.
•   Experience with PAI and PAI readiness planning. Experience with other commercial product launch preparation activities.
•   Demonstrated ability to work in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of corporate strategic goals.

Competencies

•   Strong scientific/technical skills.
•   High level of analytical & problem solving skills required.
•   Ability to demonstrate an advanced understanding of quality improvement tools & techniques required.
•   Ability to anticipate and resolve problems effectively.
•   Strong verbal communication and technical writing skills.
•   Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings.
•   Sound organizational skills.
•   Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
•   Motivates team members; fosters and nurtures teamwork.
•   Project management skills and focus on delivery of results.
•   Role model for Atara’s Values.

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.