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Specialist, Manufacturing

Company: Atara Biotherapeutics
Location: thousand oaks
Posted on: May 3, 2021

Job Description:

Job Description

The Aseptic Processing Specialist works as part of the Manufacturing team delivering on team goals to generate high quality materials used both in the clinical settings as well as commercially. The Specialist serves as the Manufacturing Owner on Contamination Controls and within Atara's Internal Manufacturing Organization and Quality Management System, including: Cleaning Processes, Gowning, Aseptic Processing, Contamination Controls risk management, Change Control , Investigations and CAPAs associated for contamination controls among others.

Work Location: Thousand Oaks, CA (northwest Los Angeles)

Reports to: Manufacturing Manager

Travel: May be required (up to 10%)

Primary Responsibilities:

* Manufacturing lead responsible for ensuring successful identification and implementation of applicable contamination controls * Investigates and documents details of deviation events that occur during the manufacture of Atara products. * Gathers and analyzes data to identify severity, support conclusions and determine root causes of deviations. * Performs impact assessments for deviations and change controls. * Supports activities and documentation related to corrections, corrective actions, and preventive actions to mitigate impact and eliminate reoccurrence. * CAPA effectiveness monitoring. * Serves as a change control owner. Works with cross-functional teams and the Change Control Board to ensure change records are properly defined, assessed, planned, implemented, reported and tracked. * Drive work streams and associated QMS records to implementation/closure to support on-time operational readiness and product availability. * Supports manufacturing-related risk management activities and mitigation efforts to reduce risks. * Contributes to the effectiveness of the Quality Management System, including identification and implementation of improvement opportunities for processes, procedures, and training to support deviation, CAPA, change control and risk management processes. * Leads/supports planning, scheduling, executing and reporting on Manufacturing projects and support programs, as needed. * Defines and analyzes key performance metrics to drive continuous improvement across manufacturing operations.

Qualifications

Education and Professional Experience:

* Bachelor's degree in science & 3 years in a technical discipline (e.g. microbiology, biotechnology, engineering) or related life science

OR

* Associate's degree in science & 8 years in a technical discipline (e.g. microbiology, biotechnology, engineering) or related life science

Or

* High school diploma / GED & 10 years in a technical discipline (e.g. microbiology, biotechnology, engineering) or related life science * Strong understanding of regulatory expectations for contamination controls and aseptic processing * Strong understanding of quality management systems and continuous process improvement principles including global cGMP requirements, and other relevant regulations and guidance.

Position Requirements:

* Excellent analytical, interpersonal, verbal and written communication skills. * Proficient in using Microsoft applications (Word, Excel, PowerPoint, Project). * Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution. * Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment. * Able to take ownership of a given assignment, proactively consulting cross-functional team members and other department representatives for information or guidance, as necessary. * Strong organizational and project management skills. * Motivates team members; fosters and nurtures teamwork. * 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'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.

Keywords: Atara Biotherapeutics, Thousand Oaks , Specialist, Manufacturing, Other , thousand oaks, California

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