The Sr. Engineer - Technical Services supports the technical activities associated with T-cell manufacturing across the Atara manufacturing network. This position provides on-the-floor manufacturing support to address deviations, support change control and CAPA, as well as support process monitoring, technology transfer, and manufacturing process troubleshooting as needed. Qualified candidates will have demonstrated technical proficiency in cell therapy manufacturing, a strong understanding of cGMP, initiative and effective collaboration with others.
Work Location: Thousand Oaks, (northwest Los Angeles), CA
Reports to: Director, Technical Services
Performs technical assessments (Product Impact Assessments, PIAs) for deviations; supports and/or owns change controls and CAPAs.
Supports investigations of process failures.
Owns and provides technical expertise in FMEA; supports and provides technical expertise for HAZOP related activities to support quality by design (QBD).
Authors, reviews and edits manufacturing documents including SOPs, batch records, specifications as necessitated by process changes.
Reviews and edits executed batch records, validation protocols and reports to assure appropriate and complete content.
Supports maintenance of process monitoring database; supports parameter tracking and trending activities; presents routine process monitoring updates from analyses on production data.
Supervises and performs development and manufacturing support work for internal and external manufacturing cleanroom processes and production areas, including process characterization studies, process engineering (improvement) activities and validation.
Supports training of internal and external manufacturing staff.
Supervises temporary and/or contingent staff working in technical services.
In collaboration with other development functions at Atara, assures effective transfers and start-up of new processes across Atara manufacturing network.
Serves as a role model for Atara's Values of patients first, innovation teamwork, community, and mindset.
TravelTravel required (up to 30%) initially to support our work with our CMO collaborator on company paid domestic travel in 2-week rotational intervals. Support local manufacturing in Thousand Oaks and two weeks at the CMO schedule for up to 6-9 months.
Physical RequirementsSubject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, laboratory, or manufacturing environment. Car and airplane travel is an essential part of the job.
Bachelor's degree in a biological or engineering science, with 5+ years of relevant industry experience or Master's degree & 2+ years of directly related 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.
Experience technology transfers and manufacturing cell therapy products preferred.
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. Experience with statistical analysis tool(s) (e.g. JMP) is required.
Excellent technical writing skills.
More about Atara Bio
We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. 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 400+ Atarians co-located by design in 4 different locations including South San Francisco (corporate headquarters), Thousand Oaks (R&D and manufacturing headquarters), Zug, Switzerland (european headquarters) and a R&D site in the Denver, Colorado area. 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. 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.