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.
The Senior Business Analyst, EMS/CMMS collects requirements and provides technical direction for the design and implementation of Atara's manufacturing systems. This position is the technical system owner for Environmental Monitoring System/Building Automation System (EMS/BAS) and Computer Maintenance Management System (CMMS). This role supports all engineering, start-up, commissioning and qualification activities. This position also requires the day-to-day support of the EMS and Manufacturing Execution System (MES) post implementation.
Reports to Director, Regulated IT
Location: Thousand Oaks (northwest Los Angeles area), CA
Supports the EMS/BAS and CMMS project in the design, development, and qualification, including managing the work of external vendors.
Supports other systems such as manufacturing execution system and lab systems as needed.
Collaborates closely with manufacturing and quality business partners in the efforts for configuration, administration, integration, and maintenance of the systems.
Works closely with the Manufacturing leadership team to ensure alignment and established priorities to meet and exceed site and corporate goals.
Travel Travel required (up to 10%)
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office or clinical environment. Car and airplane (see travel above) travel is an essential part of the job.
BS degree in engineering, computer science or information systems and 7+ years related work experience or MS degree in engineering, computer science or information systems and at least 5 years related work experience.
Experience in either EMS/BAS (Siemens) or CMMS (Blue Mountain).
Experience in either LIMS (Labware), ERP (Dynamics 365), MES (Werum PAS-X), a plus.
Demonstrated experience managing multiple simultaneous projects.
Previous experience in manufacturing or operations environment.
Demonstrated excellent understanding of cGMP execution.
Experience with computer systems validation practices.
Understanding of pharmaceutical development, clinical research, cell therapy manufacturing, and project management.
Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.
Good decision making with strong judgment through collaboration and consideration of others point-of-view.
Self-motivated, flexible and creative, able to prioritize, multi-task, and work in a fast-paced & demanding environment.
Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among a diverse group.
Experience as subject matter expert in manufacturing systems with management leadership experience.
Strong personal presence, ability to exercise sound business judgment and clear decision-making.
Process improvement experience with respect to manufacturing execution systems, a plus.
Role model for Atara's Values of patients first, innovation teamwork, community and mindset.
More About Atara Bio
Now in our sixth year, we're proud of our team of 260+ 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.
One mission "Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise" and a singular vision "Cell therapy treatment for every patient, any time provide inspiration and direction for all of us."
The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.
Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).
Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).
Working at Atara Bio
People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are "team-centric", have purposeful curiosity and can't wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a "low hubris" sort of place), 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 shared responsibility to teach and to learn from what we do and from our teammates.
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.