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Principal Engineer

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

Job Description:

Job DescriptionPosition Summary:The Principal Engineer - Technical Services leads and supports the technical activities associated with T-cell external manufacturing. This position will provide on-the-floor manufacturing support to address deviations, support process monitoring, technology transfer, and manufacturing process troubleshooting as needed. Qualified candidates for the Principal Engineer - Technical Services role should have demonstrated technical proficiency in cell therapy manufacturing, a strong understanding of cGMP, initiative, and collaboration with others.The candidate will also provide technical network leadership and cell therapy process expertise. Key elements of the position will be to own, develop, and maintain process FMEAs and risk assessments within the area of expertise, to provide network leadership to drive alignment, solve problems and prevent issues within Atara's manufacturing network. The position will strongly partner with Manufacturing, Process Development, Quality, and other functions to ensure processes are maintained and aligned between the manufacturing sites.Reports to: Director, Technical ServicesLocation: Thousand Oaks (NW of Los Angeles), CATravel: Up to 30%Responsibilities: In collaboration with other development functions at Atara, assure effective transfers and start-up of new processes across Atara manufacturing network. Lead training of Technical Services Engineering staff. Own investigations of process failures including on-the-floor execution of investigation studies. Review performance data and recommend improvements for processes and systems. Assist sites in troubleshooting and remediation to prevent future occurrence throughout the network. Support the long-range plan for production and new product introductions. Perform technical assessments for critical deviations. Provide technical expertise and participate in FMEA, HAZOP related activities to support quality by design (QBD). Function as technical SME on manufacturing processes for regulatory agency interactions and filings.QualificationsSkills and Abilities: Proven experience cell therapy process design and manufacturing support. Solid communication skills (e.g., clear and concise) both verbally and in writing. Works well in a team-based environment, solid interpersonal and teaming skills. Good decision making with strong judgment through collaboration and consideration of others point-of-view. Self-motivated and able to organize tasks and time to maximize effectiveness and efficiency. Able to understand and interpret data/information and its practical application. Able to understand and interpret data/information and its practical application. Experience with statistical analysis tool(s) (e.g. JMP) is required. Extensive experience providing technical support to manufacturing processes, equipment, and facilities. Proven experience and track record of compliance in a highly regulated environment. Demonstrated ability to effectively lead and partner in a complex, matrixed organizations. Ability to develop, implement and utilize tools to drive efficiency in meeting business needs; establish measure and evaluate performance metrics, taking actions based on results. Excellent communications skills, strong facilitation talent, and executive presence to drive cross functional objectives across Amgen's international network. Strong analytical skills to identify potential improvement opportunities.Education and Professional Experience: Bachelor's degree in a biological or engineering science, with at least 12+ years of relevant industry experience. Fundamental knowledge of cell culture and cell processing principles and techniques, as well as an understanding of analytical instrumentation/methods employed for cell characterization. Strong understanding of GMPs and proficiency in their application in manufacturing Excellent technical writing skills. Experience technology transfers and manufacturing cell therapy products preferred. Deep combination product expertise and experience including functional knowledge of applicable guidance, regulations and standards to enable future compliance. Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics. Deep and broad understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis. Able to apply strategic and critical thinking. Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)More about Atara BioMore About Atara BioWe 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 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 , Principal Engineer, Other , thousand oaks, California

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