Atara Biotherapeutics is a 300+ person publicly traded (Nasdaq: ATRA) clinical-stage biotechnology company. We are co-located in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing hub in northwest Los Angeles) with a European location in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and office in New York City. Our Southern California hub is anchored by the 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.

 

People at Atara are high integrity, collaborative, roll-up-your-sleeves types who are deeply committed to putting patients first and advancing medical care with demonstrated urgency. With many accomplished people at Atara, we share humility, flexibility, respect, teamwork, good judgment and being practical in our approach to advance our therapies. We each enjoy in the journey of advancing cutting edge programs, while responsibly teaching and learning together along the way.

 

We have many exciting career opportunities across the company and we welcome you to apply online if you are interested in an open position.

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Job Locations US-CA-Thousand Oaks
This position works with the Technical Operations teams to develop and/or improve cell assays for cell product characterization and release.  The Senior Research Associate/Associate Scientist participates in laboratory activities to support process development, evaluate and develop assay methods, and perform product characterization and phase I clinical trial release for Atara’s cytotoxic T cell products. He/she is responsible for optimizing and standardizing the existing and new assays for transferring to QC function. Under minimal supervision, the role includes performing assay development experiments, carefully documenting methods and materials, writing technical reports and communicating findings. He/she is also expected to maintain a core function for the Process Sciences team. Reports to:   Principal Scientist of Analytical Sciences Location:   Thousand Oaks, California Primary Responsibilities - Develops assays for characterizing cell therapy products. - Optimizes established assays and develops protocols for qualification/validation. - Collaborates with and supports other assay development team members. - Develops and banks reference controls and standards. - Evaluates reagents and supplies to meet QC standard. - Documents laboratory procedures and experiments with great attention to detail in laboratory notebooks. - Writes technical reports and test methods. - Transfers developed assays to QC and provides trouble-shooting supports. 
Category
Process Sciences
ID
2020-1343
Job Locations US-CA-Thousand Oaks | US-CA-South San Francisco
  We are looking for an MD or PhD with immunotherapy experience to provide medical and scientific leadership to our engineered Mesothelin T cell programs.  Atara is developing next generation MSLN CAR T cells that target solid tumors, leveraging our experience with off-the-shelf EBV T cells to revolutionize access and speed to treatment for patients.  Novel CAR signaling domains derived from scientific collaborations will be integrated from pre-eminent academic institutions that promise to improve T cell persistence and deliver more physiologic signaling.  In addition, our solid tumor targeting MSLN CARs incorporate intrinsic checkpoint inhibition to overcome the immunosuppressive tumor microenvironment.    The candidate will serve as the development lead and the leader of the cross-functional Global Program Team for the Next-Generation MSLN CAR-T program with accountability for strategy and leadership throughout the product lifecycle, for both internal-sponsored development and for development with external collaborators. She/he will lead and facilitate the integrated development plan with the cross functional product team resulting in deliverables that align with product strategies and portfolio priorities ultimately being accountable to the Atara Executive Operations Committee   Reports to:  SVP, Chief Medical Officer Location:   Thousand Oaks, CA, or S San Francisco Travel:     Travel is required (up to 25%)   Primary Responsibilities - As Program Lead: Accountable for overall design, delivery and success of a product strategic plan, in alignment with the Atara’s portfolio strategy and corporate goals - Leads an interdisciplinary product team accountable to ensure cross-functional alignment and successful execution of the strategic plan for the program - Responsible for Program Team performance, articulating and taking risks with advice of the team, sets metrics to measure team performance, manages budgets, forecasts, timelines and deliverables - Develops and articulates strategic options to make the best trade-off decisions for company, global value and risk profile - Generates high-quality, clear and timely communications, escalating issues relating to strategy and resource allocation, to the Executive Operating Committee (EOC). - Drives the decision-making process, while identifying issues, and leading conflict resolution - Serves as the internal and external product champion and subject-matter expert - Key Atara stakeholder for external collaborator relationships, KOLs and SCs. - On the development end: Contributes to design of immuno-oncology CAR T clinical trials, including literature review, development of clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts and clinical study reports - Serves as a medical monitor, including evaluation of the safety, pharmacology and efficacy in ongoing and completed studies - As the medical lead of a study, responsible for ensuring data quality, summary and writing of clinical study reports in close collaboration with the clinical operations, biometrics and medical writing team. - Works on IND, EOP2, BTD, BLA and equivalent international submission documents.
Category
Clinical Development
ID
2020-1342
Job Locations US-CA-Thousand Oaks
The Manufacturing Associate works as part of the manufacturing team to deliver high quality cell therapy materials during process transfers, routine production, and technology improvements. This position contributes to the successful delivery of released product in support of clinical trials and commercial production. Primary Responsibilities - Support production in an aseptic environment - Executes on production batch records and work orders according to SOPs - Assist in all areas of cell culture and all related duties as required including (stocking, tracking inventory, material movement, maintaining metrics, filling out log sheets, and other special projects) - Assists in manufacturing batch record review - Routine maintenance and cleaning of rooms and equipment - Identifies and implements continuous improvements - Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements - Adhere to all safety protocols and procedures Skills and Abilities - Ability to follow verbal and written instructions - Problem Solving skills - Detail oriented - Team player - Strong communication skills - Strong demonstrated aseptic techniques Reports to:  Manufacturing Supervisor Function:  Technical Operations (Manufacturing) Location:  Thousand Oaks, CA Travel: 10% Physical Requirements: - Work is generally performed in a GMP manufacturing facility - Subject to extended periods of standing (8 hours) - The position requires a combination of standing in the manufacturing environment and walking around the facility - Will required weekend and some holiday work #LI-POST  
Category
Manufacturing
ID
2020-1341
Job Locations US-CA-Thousand Oaks
Atara Biotherapeutics’ allogeneic Tab-cel® platform allows for the manufacturing of a T-cell library in advance of patient’s need. Tab-cel® utilizes Epstein-Barr Virus (EBV) T‑Cells from donors with healthy immune function, which are then selected and expanded to recognize cancer cells. Thus, EBV T cells are naturally immune to Graft-versus-Host Disease (GvHD) without further need for gene editing, a common challenge in off-the-shelf cell therapy.   At Atara, we are bringing together core technologies and capabilities to develop next-generation off-the-shelf CAR-T immunotherapies, leveraging the unique features of the Tab-cel® platform. We are also collaborating with academic leaders and leveraging our world-class T-cell manufacturing and research expertise with the goal of rapidly advancing our CAR-T programs.   The Principal Scientist - CAR-T Platform Development is an integral member of the Preclinical Research Laboratory Group and brings extensive engineered T cell product development expertise. This role oversees the development of the next generation of allogeneic, off-the-shelf CAR-T therapies for our expanding pipeline, with special interest to the challenges posed by the immunosuppressive nature of the tumor microenvironment. The candidate must have an established record of leadership in an industry setting with extensive laboratory-based CAR-T cell expertise.   Reports to              Sr. Director of Preclinical & Translational Science   Location                 Thousand Oaks (northwest Los Angeles area), CA   Position Responsibilities - We are looking for a talented, highly motivated individual to develop and lead the next-generation of off-the-shelf CAR-T therapies at Atara, leveraging the company’s unique Tab-cel® platform, with special focus on strategies to counteract the immunosuppressive tumor microenvironment - Develops and leads a group of diverse scientists and research associates to facilitate new CAR-T programs and oversee IND-enabling in vitro studies. - Manages activity of direct reports and preclinical development project teams. - Independently designs and executes studies to facilitate preclinical proof-of-concept activity for efficacy and safety. - Develops and leads strong collaborative relationships with internal and external groups. - Coordinates study reports, summaries, and presentations supporting experimental results. - Role model for Atara’s Values of transparency, respect, accountability, integrity, and trust.   Travel May be required (up to 10%).   #LI-POST
Category
Pre-Clinical
ID
2020-1340
Job Locations US-CA-Thousand Oaks
The Sr. Scientist/Principal Scientist - Translational Research, This Translational Biomarker Lead position will be responsible for executing the translational research activity for one or more of Atara’s unique cellular therapy programs targeting a diverse array of exciting immune and oncology indications including multiple sclerosis, lymphoma, and solid tumors. An ideal candidate would bring a broad cross functional understanding of cell therapy clinical development and a desire to engage with all members of the product development teams including regulatory, clinical operations, clinical sciences, biostatistics, data management, and translational laboratory science.  This exceptional biomarker lead will be responsible for collaboratively developing, enacting, and functionally achieving key translational research goals unique to supported cell therapy programs, disease areas, and therapeutic indications by managing both internal and external research assets and CROs.  In addition, this individual would be involved in clinical protocol review, central vendor establishment, vendor qualification, correlative assay design, translational data analysis, and CRO bidding.   Reports to Director of Translational Research Location Thousand Oaks, CA, San Francisco, CA Travel Travel may be required (up to 20%). Position Responsibilities - Accountable for management of Translational Research input and deliverables in this function while serving as a Biomarker Lead for designated clinical programs. - Promotes the application of the principles of Atara’s Translational Science Department to facilitate and accelerate the development of novel cellular therapies through clinical-translational and biomarker excellence - Represents the Translational Science function for a variety of cell therapy products and programs. - Establishes robust scientific expertise in a variety of immune and oncology scientific areas to support translational scientific leadership and maintain a focus on therapeutic strategy. - Implements and executes biomarker strategies for cancer and autoimmune disease to complement clinical development plans, including integration of patient sample management plans and strategy - Contributes to the clinical execution and integration of cutting edge molecular and immune assays to extend Atara’s Translational Science capabilities - Collaboratively tailors a scientifically rigorous and achievable set of translational goals designed to maximize the research potential of highly precious clinical trial specimens. - Understands the roles of and has frequent communication with cross functional study representation including regulatory, data management, clinical operations, clinical science, and statistical programming. - Perform and support efforts in correlative data analysis from a variety of translational data sources - Has a firm grasp on parameters of assay qualification, development, and validation. - Responsible for accurately maintaining budget and managing translational costs associated with a clinical trial testing. - Fosters the development of novel clinical assays, through internal or external resources, related to adoptive T-cell therapies and immunotherapy for use in a clinical trial setting, with focus on companion diagnostic assays having prognostic value. - Ensures that the department maintains current awareness in area of expertise, enhances the scientific credibility of Atara through contributions to the scientific literature (publications/presentations) and through interactions with academic collaborators - Establishes and maintains working relationship with contract laboratories and consultants, and Atara’s internal Translational Laboratory and Translational Research operations. - Contributes to development and writing of clinical trial or regulatory documents including: IND, NDA, BLA, IB, Clinical Protocols and Synopses - May supervise others.    
Category
Translational Sciences
ID
2020-1339
Job Locations US-CA-Thousand Oaks
The Regulatory Project Manager is responsible for the coordination, prioritization and tracking regulatory deliverables and submissions associated with the company’s research, development, and post-marketing activities for a variety of therapeutic areas.  The Project Manager for the Regulatory Affairs Team, liaises and integrates with the Project Leadership teams to ensure alignment with the integrated project plan. The role will also be key to supporting upcoming regulatory filings.   Reports to:   Associate Director, Regulatory Affairs Project Management Location:    Thousand Oaks, CA Travel:     Less than 5%   Primary Responsibilities: - Identify and document all regulatory project deliverables from each functional area for global regulatory submissions. - Maintain detailed timelines for global regulatory strategies for assigned therapeutic areas in US, EU, CAN, and ROW, and ensure planning and coordination of activities via the Submission Teams. - Ensure product specific regulatory strategies are documented, maintained, updated, kept on schedule and proactively communicated. - Monitor and report on project progress on a consistent basis to various stakeholders - Facilitation of product specific regulatory meetings and functional sub-teams by preparing meeting schedules, agenda, minutes, action items list, Gantt charts and timelines. - Work with the regulatory leads and project team to identify and mitigate risks to meeting regulatory submission goals, address any delays and escalates when necessary. - Proactively identifies issues, drives for consensus, and resolves conflict. - Provides Project Management services as needed to support regulatory projects for non-product related initiatives. - Conduct lessons learned sessions to identify areas for improvement and maintain tracker for implementation of short and longer-term corrective and improvement measures into standard regulatory project management practices.
Category
Regulatory Affairs
ID
2020-1336
Job Locations US-CA-South San Francisco | US-CA-Thousand Oaks
Atara Biotherapeutics is a pioneer in T-cell immunotherapy leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with severe diseases including solid tumors, hematologic cancers and autoimmune disease. With our lead program in Phase 3 clinical development, Atara is the most advanced allogeneic T-cell immunotherapy company and intends to rapidly deliver off-the-shelf treatments to patients with high unmet medical need.   Atara is applying its platform to create a robust pipeline including: tab-cel® (tabelecleucel) in Ph3 development for Epstein-Barr virus-driven post-transplant lymphoproliferative disease (EBV+ PTLD); ATA188, a T-cell immunotherapy targeting EBV antigens as a potential treatment for multiple sclerosis; and multiple next-generation chimeric antigen receptor T-cell (CAR-T) immunotherapies for both solid tumors and hematologic malignancies. Our investigational off-the-shelf T‑Cells are intended for rapid delivery from inventory to patients.   Improving patients’ lives is our mission, and we will never stop working to bring transformative therapies to those with serious medical conditions.   Atara is headquartered in South San Francisco and our leading-edge research, development and manufacturing facility is based in Thousand Oaks, California.   The Associate Director, Global Commercial Analytics – Forecasting Lead will be responsible for assessing the commercial opportunity associated with Atara’s full portfolio of allogeneic cell therapies over the course of their development and commercialization. This individual will be responsible for financial modeling as well as providing critically important insights to support senior leadership decision-making regarding asset commercialization, portfolio prioritization, and business development opportunities.     Key pipeline portfolio forecasting needs include refining the assessment of opportunity associated with tab-cel®, for which we will initiate the submission of a BLA to the FDA by the end of year and is entering a pivotal trial in other EBV+ malignancies. Other needs include developing an updated view of the opportunity associated with Atara’s earlier programs including ATA-188 in multiple sclerosis, ATA-3219 in B-cell malignancies, and ATA-2271/3271 in mesothelioma and other solid tumor types.   Reports to                 VP, Commercial Planning   Location                    California-based; office location will be either South San Francisco, CA or Thousand Oaks, CA   Responsibilities - Creates, manages, validates, and refines short and long-term global revenue forecast models as relevant for products across Atara’s portfolio and to support evaluation of business development and partnerships (as relevant). - Successfully collaborates and negotiates to align cross-functional and cross-geography planning and forecast assumptions (e.g. PMA, Global Marketing, HEMAR, medical, R&D, and regional leadership). - Develops effective plan and materials to communicate and document forecast assumptions, synthesized outputs, and key business implications to senior leadership. - Leads design of and oversees the execution of commercial assessments that include secondary and primary research to generate insights and inform forecast updates or development.   - Contributes, as required, to other Global Commercial Analytics initiatives / deliverables (e.g. secondary data analysis, competitive intelligence, market research). - Drives the use of the leading tools and techniques in Forecasting. - Responds flexibly and adaptively to the needs of the organization through a culture of continuous improvement and innovation.   Travel– Role does not currently require any travel due to COVID-19 considerations; minimal future travel may be required (up to 5%).    #LI-POST
Category
Commercial Ops
ID
2020-1335
Job Locations US-CA-Thousand Oaks
This position will work with the Technical Operations teams to strategize and design approaches to develop tools to purify viral vectors (adenovirus, retrovirus, Epstein Barr virus) used in cell therapy processes (auto- & allo). This position will also interact closely with process sciences allogenic cell processing groups, quality control, and internal/external manufacturing. The Principal Scientist/Associate Director Downstream Vector Development is responsible for leading the downstream vector development, optimizing, and qualifying downstream processes to produce quality vector reagent with high yield, relevant purity, and scalability. These processes may include cell lysis, depth filtration, TFF, TF/DF, UF/DF, ion exchange chromatography, formulation development, filling, and cryopreservation. In addition, the Principal Scientist/Associate Director will support internal/external GMP manufacturing activities for viral vectors. The Principal Scientist/Associate Director is required to have experience developing manufacturable viral vector processes of vector reagent suitable for auto- and allogeneic cell therapy processes. The candidate must have successfully demonstrated technical proficiency, scientific innovation, independent thinking, interaction with and training team members, and cross-functional collaboration.   Reports to:  Senior Director Viral Vector Development   Location:  Thousand Oaks (northwest Los Angeles area), CA   Primary Responsibilities - Development of scalable and robust downstream viral vector processes - Design experiments related to development, optimization, scale-up of all steps in a viral vector purification process and cell product viral clearance studies - Identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding - Apply DOE and other advanced statistical techniques to design experiments related to process characterization Author high-quality documents, including technical reports, SOPs, and experimental protocols - Serve as PD representative and participate in cross functional meetings - Contribute to scale up activities and draft tech transfer related documents (e.g. process description, process flow diagram) - Conduct facility fit exercise, review batch records and provide comments, support MFG activities internally or externally - Provide technical support (e.g. process/operational gap identification and troubleshooting) to internal or external MFG group - Support Quality Assurance teams to help evaluate deviations, CAPA and Change Controls (both internal and external) #LI-POST
Category
Process Sciences
ID
2020-1334
Job Locations US-CA-Thousand Oaks
This Senior Research Associate / Associate Scientist will be an integral member of the Translational Sciences team, responsible for conducting technical development of next generation assays and applying these assays to patient samples from Atara’s groundbreaking trials in cellular therapy.  Qualified candidates will be capable of independently conducting clinical sample testing, performing directed validation of bioassays, communicating results with the Translational Sciences team, and generating written reports.  In addition to having extensive laboratory-based expertise in a relevant biological field an exceptional candidate will demonstrate a strong team-based work ethic and will possess a diversity of unique skills, perspectives, and ideas which will serve to bolster Atara’s efforts to transform the lives of patients with serious medical conditions through pioneering science, teamwork and a commitment to excellence.    Reports to:    Scientist   Location:   Thousand Oaks, California Primary Responsibilities: - Independently develops, optimizes, or validates novel bioassays intended for use on high value clinical specimens. - Conducts full scale testing of clinical specimens following established protocols with high attention to detail. - Authors and critically reviews protocols for pre-validation/validation of clinical assays. - Performs primary immune cell isolation and multi-parameter immunophenotyping by flow cytometry. - Maintains detailed documentation of laboratory procedures and experiments. - Write study reports, summaries, and presentations supporting experimental results. - Supports large-scale experiments with multiple team members simultaneously contributing to completion.   Travel:  Travel required (up to 10%).   Physical Requirements: Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office or laboratory environment.   #LI-POST  
Category
Pre-Clinical
ID
2020-1333
Job Locations US-CA-Thousand Oaks
At Atara, we are bringing together core technologies and capabilities to develop next-generation off-the-shelf CAR-T immunotherapies, leveraging the unique features of the Tab-cel® platform. We are also collaborating with academic leaders and leveraging our world-class T-cell manufacturing and research expertise with the goal of rapidly advancing our CAR T programs.   The Research Associate / Senior Research Associate - CAR-T Development is an integral member of the Preclinical Immunotherapy Research group. The Research Associate / Senior Research Associate – CAR-T Development will serve as a technical expert in the generation and characterization of novel CTL and Chimeric Antigen Receptor (CAR) T cell therapies. The successful candidate will perform experiments to support new product development and IND-enabling activities for Atara’s CAR T cell pipeline. The candidate must have extensive laboratory-based expertise with T cell biology, immunology and CAR-T.   Location         Thousand Oaks (northwest Los Angeles area), CA Travel         May be required (up to 10%)   Position Responsibilities - Performs retroviral (gamma retrovirus and/or lentiviral) transductions of primary T cells and propagation. - Evaluates allogeneic CAR T cell activity, efficacy, and alloreactivity. - Performs primary immune cell isolation and multi-parameter immunophenotyping by flow cytometry. - Designs and executes assays to evaluate target-specific T cell characteristics and function. - Performs mammalian cell culture and production of recombinant transient and stable mammalian cell lines. - Contributes to experimental design and project direction. - Facilitates the establishment of a molecular and cellular lab infrastructure and routine operations. - Maintains detailed documentation of laboratory procedures and experiments. - Prepares data presentations for internal group meetings. - Role model for Atara’s Values of patients first, innovation teamwork, community and mindset. #LI-POST
Category
Pre-Clinical
ID
2020-1332
Job Locations US-CA-Thousand Oaks
Atara Biotherapeutics’ allogeneic Tab-cel® platform allows for the manufacturing of a T-cell library in advance of patient’s need. Tab-cel® utilizes Epstein-Barr Virus (EBV) T‑Cells from donors with healthy immune function, which are then selected and expanded to recognize cancer cells. Thus, EBV T cells are naturally immune to Graft-versus-Host Disease (GvHD) without further need for gene editing, a common challenge in off-the-shelf cell therapy. At Atara, we are bringing together core technologies and capabilities to develop next-generation off-the-shelf CAR-T immunotherapies, leveraging the unique features of the Tab-cel® platform. We are also collaborating with academic leaders and leveraging our world-class T-cell manufacturing and research expertise with the goal of rapidly advancing our CAR T programs.   The Scientist/ Sr. Scientist - CAR-T Development Lead is an integral member of the Preclinical Immunotherapy Research group and brings extensive engineered T cell product development expertise. The Associate Scientist / Scientist – CAR-T Development will serve as a technical expert in the generation and characterization of novel CTL and Chimeric Antigen Receptor (CAR) T cell therapies. The successful candidate will independently perform experiments to support new product development and IND-enabling activities for Atara’s CAR T cell pipeline. The candidate must have an established record of scientific accomplishments in an academic and/or industry setting with extensive laboratory-based CAR-T cell expertise.   Reports to              Sr. Director of Preclinical & Translational Science   Location                 Thousand Oaks (northwest Los Angeles area), CA   Position Responsibilities - We are looking for a talented, highly motivated individual to lead the development of off-the-shelf CAR-T therapies at Atara, leveraging the company’s unique Tab-cel® platform - Applies expert knowledge to independently design and execute studies using new CAR-T product candidates, to facilitate preclinical proof-of-concept and support of IND preclinical data package. - Validate targets, optimize CAR construct design and CAR-T cell generation, and explore therapeutic potential and alloreactivity of resulting CAR-T lead candidates. - Perform retroviral and/or lentiviral transductions of primary T cells and propagation - Multi-parametric immunophenotyping by flow cytometry - Write study reports, summaries, and presentations supporting experimental results. Maintains detailed documentation of laboratory procedures and experiments - Develops strong collaborative relationships with internal and external groups. - Role model for Atara’s Values of transparency, respect, accountability, integrity, and trust.   Travel May be required (up to 10%)   #LI-POST
Category
Pre-Clinical
ID
2020-1330
Job Locations US-CA-Thousand Oaks | US-CA-South San Francisco
The Sr. Director, People Business Partner is responsible delivering people processes, programs and initiatives for a designated client group.  The role will deliver value added solutions across a range of People areas including, talent management, performance management, change management, strategic work force planning, employee engagement and total rewards. In addition, the role will lead the People Business Partners team.   Reports to:                           Vice President, Human Resources Location:                              Thousand Oaks, CA or S. San Francisco, CA Travel:                                 Some travel is required (10-15%)   Primary Responsibilities - Serve as People Business Partner leader with oversight of primarily the R&D functions and supporting additional client groups. - Influence and build relationships with staff team and people managers to reinforce the People team’s position as a trusted advisor to the business. - Provide coaching and support to the leaders to drive high performance that enables the delivery of strong performance. - Drive people and business metrics to inform and proactively manage people decisions (data driven decisions). - Facilitate innovative business and people practices enhancing business outcomes. - Drive the talent agenda to build a sustainable pipeline of top talent through acquisition, appropriate talent moves, retention and development actions. - Strategically lead people activities (talent, performance, compensation etc.) with the business in a manner that differentiates talent and leads to a high performing culture. - Challenge business leaders to ensure a better outcome on people related matters. - Recommend, partner, a drive innovation and change to enhance existing People practices to enable scale and growth. - Lead and mentor a team of People Business Partners across multiple geographies.
Category
HR
ID
2020-1329
Job Locations US-CA-Thousand Oaks
The Sr. Manager/Associate Director, Operational Excellence (Business Performance) role is responsible for developing and effectively deploying an operational excellence program for Atara. This position creates, coordinates, and drives all aspects of the deployment of the operational excellence strategy.  This role is a key contributor to the development and implementation of the Operational Excellence program to achieve excellence in the end to end commercial and clinical value streams at Atara Bio.    Work Location: Thousand Oaks, CA Reports to: Sr. Director, Operations   Primary Responsibilities - Work with Senior Director to create and implement a strategic vision and road map for the operational excellence program - Support leadership teams by developing and implementing tailored operational excellence practices - Create, maintain, and deliver training to support the advancement of operational excellence at Atara - Provide coaching, mentoring, and assessments of operational excellence programs at Atara - Develop business performance tools, analytics, dashboards, and summaries to advance Atara goals - Generate and interpret reports on performance to support effective planning, risk management, scenario planning and operational execution at Atara - Lead comprehensive analysis, simulations, and apply other operational excellence methodologies to drive improvements in business performance and productivity - Provide facilitation and implementation support for continuous improvement activities such as 5S, kaizens, Process Mapping, problem solving and FMEAs - Provide direct support to senior level leadership and perform functional leadership duties as needed  Additional Functions and Responsibilities - Demonstrate strong leadership and communication skills to work across functions and influence to facilitate execution of key projects and initiatives - Be flexible to support prioritized Atara initiatives in whatever capacity is required  Travel: Travel required (up to 35%). #LI-POST
Category
Supply Chain & Op Excellence
ID
2020-1323
Job Locations US-CA-Thousand Oaks
The Manager, Quality Control leads a team of QC associates executing bioassay and associated cell culture operations in support of routine GMP in-process, release, and stability testing for late phase clinical/commercial allogeneic cell therapy products.   Location: Thousand Oaks (northwest Los Angeles area),   Primary Responsibilities: - Schedules all bioassay and associated cell culture activities and ensures coordination with downstream testing. - Troubleshoots cell culture assays/instruments. - Tracks/trends all QC bioassay and cell culture results and processes. - Leads bioassay and cell culture laboratory investigations for all NC/OOS/OOT results. - Ensures the quality and timely delivery of all data supporting bioassay and cell culture testing. - Manages, coaches, and develops team of QC associates. - Maintains the lab in a state of inspection readiness. - Writes and reviews technical documents i.e. SOPs, qualification/validation protocols and reports. - Performs analytical assay qualification/validation and transfers. - Leads/participates in internal/external audits. - Serves as an SME for Atara and CMOs/CTLs.  Travel             Travel may be required (up to 25%)   #LI-POST
Category
Quality
ID
2020-1321
Job Locations US-CA-Thousand Oaks | US-CA-South San Francisco | US-Pacific Northwest
The Sr. Manager / Associate Director Biostatistics performs duties of a project or trial statistician to support clinical development projects/trials as required. Provides statistical input and guidance into the development of clinical protocols and assures well-designed clinical trials. Provides statistical expertise to analyze, interprets and communicates the results of clinical trials and (non) clinical experiments. Takes on statistical responsibility in the preparation of regulatory interactions. Main area of experience preferred is late stage oncology trials (i.e. phase 2 or 3). Industry experience is required. Good communication skills, collaboration across functional areas and solid clinical statistical experience are essential. Reports to:   Director of Biostatistics Location:   Thousand Oaks, CA or South San Francisco, CA.  Remote location will be considered.  Travel:        up to 10%   Position Responsibilities: - Perform duties of a project or trial statistician to support multiple clinical development projects/trials. - Provide statistical input during protocol development to ensure adequacy of proposed study designs with respect to statistical feasibility. - Develop statistical sections of study protocol and statistical analysis plan. - Perform statistical analyses of data and interpret results to ensure validity of conclusions. - Ensure achievement of statistical deliverables and milestones in coordination with other functions including clinical research, statistical programming, regulatory, data management, and medical writing. - Guide CRO biostatistics for outsourced projects and assure compliance with the specifications by reviewing/validating vendors' deliverables. - Collaborate with data management and clinical operations over the course of trials to provide statistical input to study conducts and database development as well as data collection/cleaning. - Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation. - Interact with medical writing in development of statistical and integrated clinical/statistical reports and other documents containing statistical information. - Contribute to the development of functional-level standards, tools, and templates.
Category
Clinical Development
ID
2020-1318
Job Locations US-CA-Thousand Oaks
The Sr. Medical Director provides hands-on and strategic input for PV activities associated with investigational and commercial stage products. This individual helps build the Safety Department and has a highly visible role across all levels of management and functional areas.   Reports to       Vice President, Safety Location         Thousand Oaks (northwest Los Angeles area), CA Travel             Up to 20%   Primary Responsibilities - Medical safety expert for products. - Signal detection, signal investigation and assessment, literature review, proactive management of the benefit-risk profile for assigned products and any resultant activities such as revisions to core safety information. - Risk management activities, including risk strategies for assets in all phases of development and life-cycle. - Routine PV activities of assigned programs including medical review, analysis of similar events, and literature review. - Coding reviews and reconciliation activities in collaboration with Data Management. - Coordination and project management of aggregate safety reports (e.g. PSURs/PBRERs, PADERs). - Contribution to safety sections of key documents (e.g. protocols, ICFs, IBs, RMPs, CDS, labels, INDs). - Contribution to regulatory submission documents, response to queries and other regulatory enquiries. - Performs aggregate analyses of specific events across studies, prepares and presents safety analyses at the Safety Committees, and writes Safety Assessment Reports. - Interacts with contract vendors (case processing, call center, etc.) to resolve safety-related issues. - Contributes to Post Authorization Safety Studies (PASS) and safety registries. - Reviews Safety Data Exchange Agreements as applicable. - Supports the safety department in organizing post-marketing activities in all applicable regions. - Contributes to and reviews SOPs. - Serves as a PV Safety contact to other Atara’s departments, EU QPPV, clinical sites, vendors and partners. - Prepares for regulatory inspections and audits and develops corrective action plans when needed. - Prepares training material for internal and external safety presentations (e.g. investigators meetings, SIVs). #LI-POST
Category
Safety
ID
2020-1313
Job Locations US-CA-Thousand Oaks | US-CA-South San Francisco
Title: Associate Medical Director/Medical Director   Position Summary: This role supports the growth of Atara Bio's pipeline in immuno-oncology and hematology-oncology at the clinical trials level. In collaboration with clinical and project teams of the company, the successful candidate plans, designs, and executes clinical development research studies to evaluate the efficacy, safety, clinical pharmacology, and pharmacokinetics of biologic and cellular immunotherapies. The position is also on-point to initiate and manage scientific collaborations with pre-eminent academic institutions, investigators, and consultants, culminating in participation in interactions with health authorities to support CMA/BLA submissions. This role also serves as a critical internal resource for clinical science for a variety of functions needing clinical science input, ranging from pre-clinical to commercial. Reports to: Vice President, Clinical Sciences   Location: Thousand Oaks (NW Los Angeles area), or South San Francisco, CA. Willing to consider remote basis.   Travel: Travel may be required (up to 25%)   Primary Responsibilities - Serves as the clinical lead on one or more Phase 1-Phase 3 studies. - Designs and optimizes immuno-oncology and biologic therapy clinical trials, including development of clinical protocols and amendments, investigator brochures, annual reports, abstracts, manuscripts and clinical study reports in collaboration with the clinical development team. - Serves as a medical monitor, including evaluation of the safety, pharmacology and efficacy in ongoing and completed studies in close collaboration with the safety and clinical operations teams. - Provides consulting for clinical perspective for various internal functions such as Commercial, Medical Affairs, Business Development, Pre-Clinical/Translational Science. - Interfaces and leads interactions with investigators, academicians, and thought leaders via a variety of interaction settings including academic society meetings, advisory boards, and investigator meetings. - As the medical lead of a study, responsible for ensuring data quality, summary and writing of clinical study reports in close collaboration with the clinical operations, biometrics, and medical writing teams. - Works on regulatory submission documents including those for BLAs or CMAs. - Establishes and implements exploratory pharmacodynamic, predictive and prognostic biomarker plans in conjunction with pre-clinical scientists, consultants and collaborators. - Attends scientific meetings pertinent to clinical science activities - Maintains clinical and scientific awareness in area of expertise - Ensures adherence to Atara Bio’s Standard Operating Procedures and values, maintains the highest level of ethical behavior, leads by example #LI-POST
Category
Clinical Development
ID
2020-1308
Job Locations US-CA-Thousand Oaks
Manager/Sr. Manager Product Quality Leadership   Thousand Oaks (Los Angeles)   Reports to: Sr. Director Product Quality Leadership   Location: Thousand Oaks (northwest Los Angeles)   Position Summary: This position ensures a consistent quality oversight / approach throughout the Development Process and the Commercial Product Lifecycle for assigned Atara products. The Product Quality Leader acquires and applies product-quality knowledge and acts as the quality expert for assigned products throughout the product lifecycle working closely with the product teams and partners.    Primary Responsibilities: - Serves as the quality expert for assigned ATARA programs in specific areas including bioassays and is responsible for supporting and implementing strategic quality decisions throughout the product lifecycle. Provides a proactive front-end approach to product quality. - Provides direction, coordination and alignment across different functions and influences both strategic and tactical Quality input to develop product quality strategies and life cycle management decisions for both clinical and commercial products in alignment with overall product strategies and is accountable for decisions on product quality. - Actively monitors product metrics and signals (e.g. cpk /stability, etc.) and initiates / supports improvement projects to enhance performance and /or mitigate quality or compliance risks across development portfolio.  - Works in partnership with Process Science to ensure there are established overall Product Quality Profiles and implementation of QbD principles. - In collaboration with operations, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations. - Supports and enables management of Quality Risk Management (QRM) for Atara products. - Participates in and supports complex deviation investigations, Material Review Boards, Change Management, Specification Committee, critical quality complaint resolution activities.  - Quality approver of key strategic product documents (e.g. Specifications, Stability Plans, Process descriptions, QbD documents, Process Development plans). - Ensures quality reviews are performed and standards established for regulatory filings, inspections and compliance audits as required.  - Represents Quality in CMC Team and technical meetings to provide strategic quality leadership to product development, registration, and approvals. - Manages the APR / PQR, coordinating cross functionally to ensure regulatory requirements are met and that actions arising are managed to conclusion. - Interfaces with Regulatory Affairs to author, review, and approve filings, and represents Quality in product related agency meetings.    Travel: Up to 30% #LI-POST
Category
Quality
ID
2020-1305
Job Locations US-CA-Thousand Oaks
The individual will provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet product goals. As a product expert in Quality, the Product Quality Director has responsibility for overseeing a group of cross-functional personnel to ensure all aspects of phase appropriate activities are managed.  Product Quality Director will work with management regarding operational/organizational strategy and have responsibility for providing technical input for late-stage and commercial regulatory files, comparability studies, RTQs, specifications and PQ operational strategies.  As a product expert in Quality, the Product Quality Director has responsibility for working directly with CMC Leaders, Quality Control (QC), Regulatory, Process Sciences (PS), Quality Assurance (QA), etc. on the resolution of issues associated with process/manufacturing, In-Process Control (IPC), analytical methods, specifications, reference standards, importation testing, investigations, change control, regulatory submissions, international expansion and inspections related to product(s).   Primary Responsibilities: - Serves as the quality expert for assigned ATARA programs and is responsible for making strategic quality decisions throughout the product lifecycle. Provides a proactive front-end approach to product quality. - Provides direction and alignment across different functions and influences both strategic and tactical Quality input to develop product quality strategies and life cycle management decisions for both clinical and commercial products in alignment with overall product strategies and is accountable for decisions on product quality. - Actively monitors product metrics and signals (e.g. cpk /stability, etc.) and initiates / supports improvement projects to enhance performance and /or mitigate quality or compliance risks across development portfolio.  - Works in partnership with Process Science to ensure there are established overall Product Quality Profiles and implementation of QbD principles. - Leads investigations in response to quality signals / complaint trends or critical deviations. Actively gathers necessary SME’s (e.g. Technical/Regulatory) and leads team to resolve. - In collaboration with operations, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations. - Supports and enables strategic management of Quality Risk Management (QRM) for assigned Atara products. - Participates in and supports complex deviation investigations, Material Review Boards, Change Management, Specification Committee, critical quality complaint resolution activities.  - Quality approver of key strategic product documents (e.g. Specifications, Stability Plans, Process descriptions, QbD documents, Process Development plans). - Ensures holistic quality reviews are performed and standards established for regulatory filings, inspections and compliance audits as required.  - Acts as the lead Quality input to ensure the product teams are fully aligned around the Quality Strategy. - Owns the APR / PQR, coordinating cross functionally to ensure regulatory requirements are met and that actions arising are managed to conclusion. - Interfaces with Regulatory Affairs to author, review, and approve filings, and represents Quality in product related agency meetings. - Represents product quality in meetings with regulatory agencies and supports regulatory inspections.  Travel: Up to 30%   #LI-POST
Category
Quality
ID
2020-1303
Job Locations US-CA-Thousand Oaks
Atara Biotherapeutics’ allogeneic Tab-cel® platform allows for the manufacturing of a T-cell library in advance of patient’s need. Tab-cel® utilizes Epstein-Barr Virus (EBV) T‑Cells from donors with healthy immune function, which are then selected and expanded to recognize cancer cells. Thus, EBV T cells are naturally immune to Graft-versus-Host Disease (GvHD) without further need for gene editing, a common challenge in off-the-shelf cell therapy.   At Atara, we are bringing together core technologies and capabilities to develop next-generation off-the-shelf CAR-T immunotherapies, leveraging the unique features of the Tab-cel® platform. We are also collaborating with academic leaders and leveraging our world-class T-cell manufacturing and research expertise with the goal of rapidly advancing our CAR T programs.   The Director - CAR-T Platform Development Lead is an integral member of the Preclinical Research Laboratory Group and brings extensive engineered T cell product development expertise. This role oversees the development of the next generation of allogeneic, off-the-shelf CAR-T therapies for our expanding pipeline, with special interest to the challenges posed by the immunosuppressive nature of the tumor microenvironment. The candidate must have an established record of leadership in an industry setting with extensive laboratory-based CAR-T cell expertise.   Reports to              Sr. Director of Preclinical & Translational Science   Location                 Thousand Oaks (northwest Los Angeles area), CA   Position Responsibilities - We are looking for a talented, highly motivated individual to develop and lead the next-generation of off-the-shelf CAR-T therapies at Atara, leveraging the company’s unique Tab-cel® platform, with special focus on strategies to counteract the immunosuppressive tumor microenvironment - Develops and leads a group of diverse scientists and research associates to facilitate new CAR-T programs and oversee IND-enabling in vitro studies. - Manages activity of direct reports and preclinical development project teams. - Independently designs and executes studies to facilitate preclinical proof-of-concept activity for efficacy and safety. - Develops and leads strong collaborative relationships with internal and external groups. - Coordinates study reports, summaries, and presentations supporting experimental results. - Role model for Atara’s Values of transparency, respect, accountability, integrity, and trust.   Travel May be required (up to 10%).   #LI-POST
Category
Pre-Clinical
ID
2020-1293