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.

 

Our mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence.”

 

Join us! 

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Job Locations US-CA-South San Francisco | US-CA-Thousand Oaks
Atara’s Global Medical Affairs (GMA) team focuses on broadening opportunities for patient access by ensuring that health care stakeholders have the evidence they need on our products and the confidence in that evidence to make informed treatment decisions. As a key pillar in the broader Atara organization, GMA has a pivotal role in bridging internal partner functions (including Research, Product Development, HEMAR and Commercial) and collaborating across the dynamic health ecosystem to ultimately deliver better patient outcomes while making care more accessible and affordable for all.   Scientific Communications in Medical Affairs plays a critical role in creating and executing strategies for communicating scientific data to external audiences.  Reporting to the Sr. Director, Scientific Communications, the Senior Manager/Associate Director, Global Publications leads cross-functional, global publication planning teams to develop and execute publication strategies that effectively communicate scientific, medical, and health economics data regarding Atara products.  The successful candidate will partner with Atara and external authors on publication development, liaise with external partners and authors on scientific publications, and oversee scientific communication vendors who support the writing of manuscripts and abstracts and creation of scientific posters and presentations.  The successful candidate will also collaborate on other priorities of the Scientific Communications team.   Reports to:      Sr. Director, Scientific Communications Location:              South San Francisco, CA or Thousand Oaks, CA (mix of on-site and remote) Travel:                 May be required (up to 20%)   Role Summary - Leads publication strategy, planning, and execution for Atara’s lead products and pipeline. - Analyzes scientific data and interprets its significance to accurately translate and compose into scientific publications for appropriate audiences. - Manages publication timelines and content development (i.e., abstracts, manuscripts, posters, oral presentations), which may require writing, re-writing, editing, and submitting to appropriate journals, medical congresses, and other venues. - Partners with Atara and external authors on publication development in accordance with Good Publications Practices and ICMJE guidelines. - Identifies, assesses, hires, and supervises vendors, freelance writers, technical professionals, and other external resources. - Oversees and ensures adherence to Atara global publication planning processes. - Develops FAQs for response to unsolicited questions related to key data releases. - Leads scientific congress activities, including critical evaluation and review of congress data and development of booth content and resources. - Communicates key publication metrics and data to Senior Leadership. - Educates and trains staff on publications. - Creates MSL resources related to key Atara scientific data. - Manages resourcing and budget, reprioritizing activities as needed.
Category
Medical Affairs
ID
2022-1875
Job Locations US-CA-Thousand Oaks
The Director, Supplier Quality Management provides QA support and oversight for Supply Chain at Atara as we start down the road to product commercialization. This role is responsible for supplier management and distribution quality for all commercial and clinical manufacturing operations to achieve corporate compliance goals as well as fostering quality throughout the organization.   Reports to:     Sr. Director External Quality Location:          Thousand Oaks, CA Travel:              Travel may be required (up to 30%)    Responsibilities - Leads the team responsible oversight of GMP compliance of suppliers used in all products in development at Atara Bio. - Develops, implements, and manages a supplier management system appropriate for the activities of Atara. Manages continuous quality improvement initiatives. - Provides support and oversight of the clinical and commercial distribution and logistics suppliers. - Develops, implements, and communicates the quality strategy, policies and programs throughout the organization. Engages colleagues in a manner that invites buy-in and adherence. - Responsible for the approval and maintenance of third parties and suppliers who provide cGMP services to Atara, including the auditing of suppliers, establishing Quality agreements and managing change notifications. Ensures approved vendor/supplier list is maintained.  - Responsible for the Technical Complaints program for Atara Bio clinical and commercial programs. - Works collaboratively with both internal and external clients/collaborators to resolve quality issues as well as maintain GMP compliance. Provides Atara’s Quality Unit’s input into third-party investigations and deviations. - Promotes positive work environment by communicating a clear direction on goals, provides support to other areas, and works in a fashion consistent with Atara Bio values. - Establishes quality metrics for Atara Bio suppliers. - Supports activities for the Manufacturing and Materials Management departments including QA review and approval of product label proofs and procedures associated with Supply Chain. - Supports other GXP functions as required. - Manages direct reports.
Category
Quality
ID
2022-1874
Job Locations US-CA-Thousand Oaks
Atara’s Vector analytical development group is looking for a Sr. Research Associate for Analytical Methods Development who will perform laboratory-based activities to design, develop and qualify analytical methods for the characterization, and release testing of the Company’s recombinant adenoviral and retroviral vectors, and cell therapy products.  This role will be assisting in development of release test method and deep analytical characterization of viral vectors, including but not limited to maturation of research analytical methodology into development and GMP, analytical method technology transfer from & to our contract vendors, and method life cycle management. The successful candidate will also be assisting in planning and executing laboratory studies, analyze experimental data and carefully document resultant information. Work Location             Thousand Oaks, CA  Travel                    Travel required (up to 10%)   Primary Responsibilities:  - Perform adenoviral, retroviral (gamma retrovirus and/or lentiviral) transduction assays of primary T cells and/or cell lines - Contribute to release and characterization assays design and development of adenoviral, gamma retrovirus, and/or lentiviral vector characteristics and function - Mammalian cell culture, generation and characterization of cell banks - Execute method development, optimization, qualification, or validation - Maintains detailed documentation of laboratory procedures and experiments - Implement reagent titration, lot-checking, and maintain proficiency testing database - Execute QC/GMP methods on a regular basis or as needed, in support of process development and product characterization - Provide user training on instruments, sample analysis, and cross-train analysts on analytical methods and - Facilitates the establishment of a molecular and cellular lab infrastructure and routine operations - Prepares data presentations for internal group meetings - Other duties as assigned
Category
Process Sciences
ID
2022-1872
Job Locations US-CA-Thousand Oaks
We are recruiting a Scientist OR Sr Scientist, T Cell Engineering to join Process Sciences Early Development group, helping to advance Atara’s cell therapy pipeline portfolio.   The individual will play a critical role in leading T cell engineering and developing novel approaches suitable for product and process design in CAR-T development. The selected candidate will involve in early development programs and milestone deliveries during product and process design, API screening, manufacturability assessment. Candidate should have in-depth understanding of immunology, T cell development, molecular biology and cell signaling. Candidate should demonstrate and stay up to date on the knowledge of principles and theories related to primary hematopoietic cell culture, gene editing, multi-color flow cytometry panel design, transcriptomics and proteomics for RTK signaling.   Based in Thousand Oaks, CA, the Scientist/Sr Scientist, T Cell Engineering will operate in a highly collaborative environment, partnering with Discovery, pre-clinical, process development, analytics, quality, and external collaboration partners.   Responsibilities include but are not limited to: - Multi-color flow panel design and operation - Cell culture of primary hematopoietic cells, such as T cell isolation, activation, differentiation, and cryopreservation - T cell subset characterization using immunotyping and genotyping approaches. - Lentiviral vector construction and generation - Gene expression and pathway analysis
Category
Process Sciences
ID
2022-1871
Job Locations US-CA-Thousand Oaks
The Research Associates/Senior Research Associates under supervision will be required directly to participating and performing in laboratory activities to support the design, development, and qualification/validation of bioanalytical methods and cell-based assays for characterization, in-process and lot release testing of engineered T cell drug products and their impurities. The candidates will be involved in assay optimization and standardization and assay transfer to QC team. This role is expected to perform assay development experiments, document methods and materials, write technical reports and communicate findings. This role is expected in cross-functional collaboration with other departments as needed. Report to: Senior Scientist, Analytical Development Location: Thousand Oaks, California Primary Responsibilities - Developing and performing T-Cell mediated target cell killing assays for evaluating alloreactivity of engineered CAR-T cell products. - Playing supporting role in developing other bioassays for cell therapy product release and characterization. - Supporting assay optimization, qualification/validation. - Collaborating with and supporting other assay development team members. - Running routine assays to produce data on behalf of Analytical Development team. - Evaluating reagents and supplies to meet quality standard. - Documenting laboratory procedures and experiments with great attention to detail in Laboratory Notebook or Electronic Laboratory Notebook (ELN). - Writing technical reports and test methods. - Participating in assay transfer and providing lifecycle supports. Travel Requirements: Travel required (up to 10%) 
Category
Process Sciences
ID
2022-1869
Job Locations US-Remote | US-CA-Thousand Oaks | US-CA-South San Francisco
The Clinical Systems Manager is a critical role that ensures proper infrastructure of the eTMF (i.e., 21 CFR Part 11 and applicable ex-US regulation compliance), creates and maintains robust eTMF processes and associated documents, manages access to eTMF by Sponsor and Clinical Research Organizations (CRO) staff, and facilitates a quality and inspection-ready eTMF by liaising and training Atara functions and CRO staff that provide documents to the eTMF.   Reports to:     Head of Clinical Systems Location:        Remote, Thousand Oaks, CA or South San Francisco, CA Travel:            Travel is not frequently required (<5%)   Primary Responsibilities - Manages access to the eTMF for internal and external users. - Ensures TMF meets internal and external quality standards and best practices. - Creates Veeva generated reports as requested by stakeholders with a goal to improve TMF compliance and quality. - Key participant in inspection readiness activities. - Collaborates with clinical study teams in the preparation and follow-up for internal and/or external audits/inspections. - Develops and delivers training to eTMF users to ensure optimal use of processes, eTMF system, and tools. - Provides support in eTMF software validation/migration/updates. - Supports eTMF and may support PleaseReview updates and maintenance initiatives. - Provides paper eTMF support as needed. - Supports a wide range of document quality control processes as applicable. - May assist in the management of eTMF Oversight vendor and quality oversight activities. - Lead or assist with other document management projects and activities as assigned by management, in support of the Clinical Systems function. Skills and Abilities - Must be able and willing to work in a high-visibility, fast-paced environment while handling multiple priorities. Must be flexible, detail-oriented, and possess excellent problem-solving skills. - Strong initiative and drive. Must be an organized self-starter who is able to anticipate departmental needs. - Ability to solve problems independently with appropriate management support. - Must be knowledgeable in industry document management requirements. - Experience with electronic document management software, principles of information systems, and related technology. - Proficiency with MS Word, MS Excel, and Adobe Acrobat. - Experience with records and/or document management standards. - Excellent interpersonal and communication skills are essential. Ability to work successfully within a cross-functional team. - Must be able to interact, communicate and present technical information to individuals at all levels of the organization.
Category
Clinical Development
ID
2022-1867
Job Locations US-CA-Thousand Oaks | US-CA-South San Francisco
The Executive Assistant, Commercial will provide high touch administrative support to the SVP, Chief Commercial Officer, and the growing commercial team in a fast-paced environment.   Reports to    SVP, Chief Commercial Officer Location     Thousand Oaks, CA or South San Francisco, CA Travel       Minimal   Primary Responsibilities:   Under limited supervision and with general direction on priorities from the SVP, Chief Commercial Officer, the position is responsible for the following: - Manages the SVP, Chief Commercial Officer and the teams’ calendars, which includes using judgment to negotiate and maximize managers’ use of time while addressing needs of the organization, as well as anticipating and resolving scheduling conflicts. Keeps team on track with work commitments. - Oversees travel arrangements and plans, including registering leadership team members for conferences and coordinating logistics and itineraries. - Manages and prepares complex expense reports. - Screens calls in order to effectively triage or route to the appropriate internal staff members. - Works cooperatively with other administrative associates. Ensures team members are prepared for project meetings by coordinating and providing all necessary materials as well as supporting managers in developing agendas and documentation as needed. - Establishes and maintains paper and electronic filing systems. Handles sensitive and confidential documentation, including SOP’s, Confidentiality Agreements, and other files relevant to the office so they are properly organized and maintained. - Will be assigned special projects and ad hoc projects or take on additional responsibilities as need including clinical operational coordination and support. - Maintains a high degree of discretion and confidentiality given the nature of the work.
Category
Administrative
ID
2022-1866
Job Locations US-CA-Thousand Oaks
The Scientist/Sr. Scientist - Analytical Development will work with the Technical Operations teams to strategize, develop, and implement bioanalytical methods and cell-based assays for characterization, in-process and lot release testing of engineered T cell drug products and their impurities that are required for CMC program milestone achievement. The role requires in-depth knowledge of immune cell production process and breadth of knowledge and experience across analytical method development for cell therapies, preferably T-cell therapies. The ideal candidate will be expected to design and perform experiments, analyze, interpret and document results with a high degree of independence. Cross-functional collaboration with Quality, Manufacturing and Regulatory functions; experience writing technical reports and GMP documentation including SOPs, risk assessments, and method transfer protocols and reports; will be critical for success.   Reports to:   Sr. Director, Analytical Development   Location:    Thousand Oaks (northwest Los Angeles area), CA Primary Responsibilities - Develop, design, optimize and qualify assays for in-process, characterization and lot release testing of T-cell therapy products and their impurities utilizing cell-based assays, immunoassays, biochemical and molecular biology methods - Lead state-of-the-art characterization approaches and develop high-throughput in-process analytical methods for cell therapies via QbD concepts - Independent execution of experiments, data analysis, and interpretation - Write analytical documents including technical reports, test-method SOPs, qualification protocols and reports, and methods transfer protocols and reports - Provide leadership during assay transfers from internal to external groups - Develop and lead strong collaborative relationships with internal and external groups - Hires, supervises, and mentors scientific staff Travel Requirements: Travel required (up to 10% as required for projects)
Category
Process Sciences
ID
2021-1865
Job Locations US-CA-Thousand Oaks | US-Remote
The External Manufacturing team is focused on enabling and ensuring cGMP compliant cell therapy manufacturing within Atara's external network to enable commercialization of Atara’s pipeline. The Sr. Manager/Associate Director, External Manufacturing role supports operational activities associated with contract manufacturing organizations (CMOs) and manufacturing partners producing and/or testing Atara products, key raw materials and intermediates.    Reports to:       Sr. Director, Manufacturing Work Location:      Thousand Oaks, CA OR Remote Travel:                   Domestic and international travel will be required (at times up to 75%)   Primary Responsibilities: - Organizes and facilitates team meetings and presentations; generate meeting minutes and clearly identify and assign actions, due dates and dependencies. - Supports operations (technical, quality, supply chain, manufacturing) activities associated with the planning, manufacture and delivery of products at CMOs and partners. - Partners with CMO to ensure successful manufacture of products required for clinical supply, process validation and/or commercial supply. - Supports guidance for process validation activities at the contract manufacturing facility. Provides technical input to Process Sciences for defining the critical parameters of new processes and provides a manufacturing perspective to support batch record design, SOP instruction development and training material content determination. - Collaborates with manufacturing quality partner and internal Atara quality teams to develop processes and systems that enable compliant, successful technology transfers, operation and lifecycle management of cGMP clinical and commercial manufacturing processes, ensuring all product delivery schedules are met. - Provides technical depth to support troubleshooting efforts and leads high-level deviation investigations. - Drives timely decisions and facilitates active communication and information flow between contract manufacturer and Atara team members. - Authors technical documents for regulatory agency submission in support of manufacturing processes and serves as process subject matter expert in health authority interactions. - Identifies and drives process optimization initiatives and addresses opportunities for efficiency and capacity improvements. - Partners with Process Sciences and Quality teams to identify and drive process optimization initiatives and address opportunities for efficiency and capacity improvements. - Supports on-the-floor manufacturing activities, document, manufacturing and validation readiness activities, materials management, championing of deviation investigations, corrective/preventative action implementation, and change control management, as well as support for regulatory inspections. - Supports technology transfer, contract negotiation and management, budgeting, project planning, metrics, and establishing joint KPIs. - Develops integrated project plans and utilizes them to identify rate limiting factors, key dependencies, and opportunities for program advancement. - Acts as cross-functional liaison to ensure project plans remain aligned with current business development strategies. - Applies decision analysis tools to analyze complex situations (especially those involving external manufacturers and partners) and recommend defensible actions and solutions. - Partners with Plant Manager, Quality Site Head, Manufacturing, Supply Chain, Logistics Coordinators and Engineering leaders to assure timely facility qualification and licensure. - Builds and maintains relationships with key personnel, both internally and with external parties. Role model for Atara’s Values of patients first, innovation teamwork, community and mindset and effectively interfaces with other line functions (e.g. Regulatory Affairs, Commercial, etc.) - Leads and fosters cross-functional working relationships with internal and external groups, lead interactions between Atara Process Sciences, Quality Assurance, Supply Chain and Project Leadership and external manufacturing entities to ensure successful development and delivery of all products. - Understands and leverages industry knowledge regarding CMO capabilities, performance, price-points and technology advancements to best enable Atara’s planning and execution of its product pipeline. - Provides support for regulatory submissions related to products manufactured at the CMO manufacturing sites for which this role has accountability.
Category
Manufacturing
ID
2021-1861
Job Locations US-CA-South San Francisco | US-CA-Thousand Oaks
We are currently seeking a passionate, highly motivated, and experienced leader for the position of Manager/Senior Manager of SEC Reporting, Technical Accounting and SOX Compliance. This individual will be responsible for preparing SEC filings (10k, 10Q, 8-K, and Proxy statement), as well as assist in technical accounting research related to new and proposed accounting standards and complex accounting transactions.    Reports To         Assistant Controller Location            Thousand Oaks or San Francisco, CA (mix of on-site and remote)     Position Responsibilities:  - Manage the preparation of Forms 10K, 10Q, and Proxy Statement including drafting financial statement footnotes and MD&A. - Responsible for coordinating, completion of, and maintaining supporting documentation for all areas of external reporting. - Manage the financial statement tie out process including coordinating with external auditors. - Prepare US GAAP and SEC disclosure checklists. - Maintain SEC reporting calendar and coordinate review process with key stakeholders. - Ensure timely compliance with SEC financial reporting rules and regulations, including all financial filings (Form 10-Ks, 10-Qs, 8-Ks, etc.). - Collaborate cross-functionally to ensure proper financial statement presentation of complex accounting areas and significant transactions. - Perform technical accounting research as needed and prepare memos documenting conclusions and proper accounting treatment. - Assist with the stock administration process, including coordinating with the stock administrator consultant and HR, reviewing employee equity awards, and assisting with communications to employees regarding their equity compensation. - Assist with internal audit and Sarbanes-Oxley related activities. - Lead special projects when assigned.
Category
Finance
ID
2021-1860
Job Locations US-CA-Thousand Oaks
The Scientist, Viral Vector Process Development is part of a growing Virology Team and is responsible for viral vector process development and analytical assays supporting Atara’s immunotherapy programs.   This role will primarily be expected to independently perform laboratory studies, analyze and synthesize data, present and defend data, and develop new assays for the characterization of vector and vector producing cells. This work will include process development and scale-up, data analysis and interpretation, maintaining impeccable documentation of work performed, authoring technical reports and supporting documents for regulatory filings, managing project schedules and program deadlines, adhering closely to established procedures and policies. This position will have the opportunity to collaborate across the three different work-streams for Viral Vector Development—cell engineering; upstream process development; and downstream process development—as well as cross-functionally with other process sciences teams, and other departments (including the T-cell development, tech transfer, and quality teams).   The candidate should be very organized, able to comply with SOPs and deadlines faithfully, and have competitive personal attributes including initiative, independent thinking, and collaboration skills.   Reports to:       Principal Scientist – Viral Vector Development Location:      Thousand Oaks (northwest Greater Los Angeles area), CA    Position Responsibilities / Experience - Mammalian cell culture; both adherent and suspension - Very good aseptic technique - Characterization of protein / virus producing cell lines - Design and independently develop characterization assays - Read and understand relevant literature and be able to extrapolate key information and/or techniques that may be utilized for developmental work - Facilitate the evaluation and onboarding of new equipment and software - Identify and implement new platforms to enhance assay capabilities - Works closely with external partners on characterization and release studies - Ability to manage workflows at external vendor or service organizations - Authors and reviews virus analytical method development, transfer, and technical reports as needed - Support method qualification and validation with partner analytical team - Lead the selection and screening assay workflow for candidate cell lines - Adheres to SOPs and protocols with no deviations - Ability to execute various immuno-assays for characterization of mammalian cells - Perform viral transduction assays (ex. retrovirus) of primary T cells and/or cell lines - Isolation of DNA and RNA samples using commercially available kits - Expert familiarity with PCR related technologies (ex. RT-qPCR, ddPCR) - Basic analysis of genetic sequences for plasmids, viruses, and cells - Maintain detailed documentation of laboratory procedures, experiment methods, and data collection - Managing project schedule and study deliverables to consistently meet deadlines - Interact cross-functionally within the process development and analytical development teams to achieve program objectives - Evaluate and prepare data slides and conclusions to communicate to the program team - Identify quality guidelines for industry standards and implements strategies to maintain compliance - Provides leadership and training to more junior team members - Other duties as assigned Travel: Ability to travel for one week in a year if necessary and safe.   Physical Requirements The ability to endure extended periods of sitting and standing, visual engagement with computer monitors, and periods of elevated noise levels. The ability and comfort to don and remove required PPE for highly controlled research/manufacturing areas with relative ease. Be able to transport boxes and other material to and from the warehouse as needed with the aid of a cart / dolly. Work is approximately 80% lab-based and 20% desk-based.
Category
Process Sciences
ID
2021-1857
Job Locations US-CA-Thousand Oaks
The Warehouse Associate works as part of the Research and Process Science teams to deliver on the team goals to receive, store, and distribute inbound materials. The position will contribute to the successful research, discovery, and implementation of new and novel techniques within these teams. The Warehouse Associate will work in different activities including warehouse and distribution processes, document review, inventory control, and materials management.  Work Location: Thousand Oaks, CA Reports to: Laboratory Services Manager Travel Requirements: Travels infrequently (5%) Primary Responsibilities - Works with the Preclinical, Translational, and Process Science groups, supporting the logistics of clinical and research programs. - Operates within the warehouse to receive and distribute, as well as provide day-to-day guidance for those exporting biospecimens. - Assists in the day-to-day warehouse and distribution operations and identify improvement opportunities. - Assists in the establishment of systems as they pertain to the new research facility. - Creates, updates, and maintains Supply Chain SOP’s to ensure they are in line with the current process steps. - Other projects and duties as assigned.   Physical Requirements:   - Work is generally performed in office and laboratory workspaces. - The position requires a combination of sedentary work, standing, and walking around the facility. - Must be able to work in environments requiring special gowning. Will be required to wear personal protective equipment over the hands, feet, and body. - Must be able to work in cold and wet environments while wearing appropriate personal protective equipment. - Must be able to maneuver warehouse equipment (WAV, pallet jacks, etc.)
Category
Process Sciences
ID
2021-1856
Job Locations US-CA-Thousand Oaks | US-CA-South San Francisco | US-Remote
Atara is a global leader in the development of allogeneic off-the-shelf cellular therapy products for patients with life-threatening diseases. The Cell Therapy Science and Operations (CTSO) Group is a functional group within Research and Development dedicated to identifying and selecting the most appropriate cell product lot from a pre-existing cellular therapy product inventory. CTSO will also develop, improve, and maintain the scientific principles, technology, and operational processes to enable efficient matching of allogeneic cell products to patients. Lot selection is mainly based on HLA-based matches between the HLA profile of an individual patient and the HLA genotype of the cell lot. For each individual to be treated with Atara cellular therapy, the CTSO team utilizes pertinent clinical information, including HLA data, and then applies Atara’s proprietary matching criteria and hierarchy to select appropriately matched product lots from the cell inventory dataset using Atara’s own lot selection process.   Reports to:          VP, Head of Cell Therapy Science and Operations Dotted line to:        Sr. Director, IT Corporate Functions Comm Enterprise Location:                      Thousand Oaks or South San Francisco, CA. Remote is also acceptable Travel:              May be required up to 15% with potential for international travel Line management:        Potentially in the future Geography:           Global Position Summary The Cell Therapy Platform Technology Lead is a member of the Cell Therapy Science and Operations (CTSO) function and a member of the Cell Therapy Operations (CTO) team. He or she will define the direction and development priorities for technology products, which support Atara’s pipeline of products. As a key member of the Cell Therapy Operations team, the Cell Therapy Platform Lead holds ultimate accountability for articulating solutions that meet the needs of the long-term vision for lot selection and Atara’s pipeline. They collaborate across multiple internal and external stakeholders and establish clear deliverables to meet business need. The Cell Therapy Platform Technology Lead bridges the gap between business and technology by collaborating with IT, department leadership, and all key stakeholders to define and prioritize new and existing features and capabilities of technology solutions supporting the CTSO team. Position Relationships - Member of the Cell Therapy Operations Team. - Member of the Cell Therapy Science and Operations Steering Committee. - Information Systems, Supply Chain, Clinical Operations and Clinical Sciences. - Primary point of contact for external vendors providing services supporting the CTSO technology platform. Primary Responsibilities: - Own product vision for how the information technology platform integrates across our business, driving end-to-end product development and roadmap initiatives. - Drive execution in collaboration with R&D, Supply Chain, Commercial, Operations, Finance, and IT. Identifying and translating pain points into elegant platform solutions. - Resource planning to ensure appropriate staffing and service provider expertise within Atara. Manage vendor engagements to direct software engineers, analysts, project managers, designers, and QA to deliver optimal technology solutions. - Research and propose technology solutions that are flexible, scalable, and fiscally reasonable. - Analyze outcomes of product development, systematize learnings, and share them effectively with the organization which may require additional context to software development lifecycles. - Continually find ways to iterate and make our product experiences better with operational efficiencies, analyzing metrics and gathering feedback from internal and external stakeholders. - Actively conduct research and define the needs of our business and partners in a structured way by applying qualitative and quantitative research. - Budget recommendations from technology development standpoint. - Training of staff on technology solutions supporting CTSO activities. - Create and maintain Work Instructions and training material related to technology solutions. - Applies expertise in regulatory GxP computer software validation practices and associated change management methodologies to improve Atara Bio’s Cell Therapy Platform. - Ensures that any new software integration into Cell Therapy Platform meets functional requirements, system compliance, and interface specifications. - Collaborates with analysts, designers, and business process owners, and system owners in the testing of new software capabilities within the Cell Therapy Platform. - Works with Information System staff to ensure system(s) will fit into existing infrastructure and meets Atara Bio standards for hardware/software systems. - Provides technical leadership to project managers, business analysts and programmers working on application project teams. - Cultivates, disseminates, and enforces functional policies, procedures, and quality assurance best practices. - Recommends, schedules, and manages software improvements, patches, upgrades, and/or purchases. Decision making authority - Outside Expenses sign-off at signature level - Line management decisions if applicable
Category
Medical Affairs
ID
2021-1855
Job Locations US-CA-Thousand Oaks
The Director, Process Development is responsible for leading process development and supporting GMP manufacturing activities for one of Atara’s allogeneic antigen-targeted T-cell immunotherapy product candidates.    Responsibilities include establishing and managing work plans to achieve program goals, assuring processes are developed in compliance with FDA regulations and those of other regulatory agencies, transferring manufacturing processes to Atara’s manufacturing department, supporting process validation activities, authoring process-related CMC sections of INDs and other regulatory filings.    This role will author and/or review sections of CMC regulatory submissions and communications and represent the Atara in regulatory interactions. The role requires breadth of experience across CMC functions with a focus in process development, and a history of substantial contribution to authoring CMC methods sections of regulatory filings.  Importantly, the Dir will have experience developing cell therapy manufacturing processes.   Reports to:   Sr. Director, Process Development   Location:    Thousand Oaks, CA (northwest Los Angeles area) Primary Responsibilities - Establishes, communicates, and manages project plans and timelines for phase-appropriate process development, transfer to manufacturing and manage activities through to punctually achieving goals - Shapes approach and policies for developing and establishing production processes. - Serves as expert in cell processing technology development for manufacture of cell therapies within a GMP manufacturing environment.        - Provides technical and GMP compliance guidance to cross-functional teams in support of project goals. - Represents the process development function for authoring, reviewing and approval of GMP and regulatory documents as appropriate, including SOPs, reports, risk and impact assessment, and filing sections. - Collaborates with Atara Analytical Development, Manufacturing, Quality and Regulatory functions as well as with functional leads of external partners to maintain alignment of goals and to navigate project obstacles. - Strategizes and leads/supervises communications with regulatory agencies regarding technical subject matter. - Leads project sub-teams and working groups and may serve as Technical Project Lead representing Technical Operations on product teams. - Hires, supervises and mentors scientific staff.   Travel Requirements Travel required (up to 15%).    
Category
Process Sciences
ID
2021-1852
Job Locations US-CA-Thousand Oaks
The Manager QA for Quality Control position, under the Plant QA organization, supports and provides quality oversight to QC and will be responsible for deviation, change control, CAPA, OOS, OOT, and Invalid Results investigations related to QC events. This role will also serve to review qualification/validation protocols and reports as well as Technical Transfer protocols and will be required to interact with the Regulatory, Process Development, and Translational Sciences Groups for ownership, review, and approval of quality records.   The Manager will multitask across multiple functional areas, while being timeline focused and flexible in their work scheduling to meet the demands of a multi-product clinical phase cellular therapy company that is transitioning to the commercial phase.   Reports to   Director, Quality Operations Location    Thousand Oaks, CA (mix of on-site & remote work) Travel      Some travel is required (20%)   Primary Responsibilities: - Understand regulatory requirements related to QC systems and data. Own the process for quality oversight of Good Laboratory Practices to ensure compliance to regulations. - Collaborate and lead discussions with other managers to ensure deliverables meet the needs across the organization. - Support Out of Specification/Trend investigations. - Review and approve QC validation, technical transfer protocols and reports. Support assay and equipment implementation and modification. - Provide Quality system record support to achieve on-time closure. Participate in cross-functional team meetings to resolve deviation and CAPA issues. - Investigate deviations using knowledge of analytical process, technical reports, validation, and equipment.          - Review, assess, and approve Change Controls plans, and/or records. - Support lot disposition activities including closure of quality records and approval of Certificates of Analysis. - Provide guidance to direct reports and team members to ensure effective execution of deliverables. - Responsible for achieving project milestones within timelines and budget. - Ensure policies and procedures are adequate and being followed. - Support regulatory filings and audit readiness initiatives. - Interface with other departments (e.g., Process Development, and Translational Science, Validation, Engineering, Facilities, Manufacturing, Regulatory Affairs, and Quality Control) to ensure achievement of Atara goals, including compliance with all applicable standards. - Perform real time documentation review concurrent with operations. - Act as the Quality representative on the floor during operations, troubleshooting, and system related maintenance. - Participate in cross-functional team meetings where QA oversight/input is required, facilitates issue resolution through problem-solving and collaboration with colleagues.     - Draft and revise SOPs, work instructions, and other controlled documents. - Work independently under general supervision and direction. - Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion. Perform and support routine quality area walkthroughs and audits. - Experience with analytical method validation, data integrity and compliance
Category
Quality
ID
2021-1850
Job Locations US-CA-Thousand Oaks
The Associate Director/ Director Operations Program Lead (OPL) plays a critical role in advancing Atara pipeline programs by leading a broad, cross-functional team within Technical Operations/CMC (including Manufacturing, Process Sciences, Supply Chain, Engineering, Quality, Finance) to facilitate the creation and execution of product development and commercialization plans for our ATA188 program. The OPL drives execution of key Technical Operations deliverables and works closely with other functions on the Global Program Team (Global Program Leadership, Clinical Sciences, Translational Sciences, Regulatory, Clinical Operations, etc.) to shape and manage program strategy & deliverables.   Work Location:          Thousand Oaks, CA (mix of on-site & remote work) Reports to:                 Senior Director, Operations Portfolio Management Travel required:       Up to 10%   Primary Responsibilities: - Own / lead the cross-functional CMC team and oversee execution of CMC program commercialization strategy through key regulatory filings (IND, BLA, etc). - Serve as the primary representative for TechOps/CMC on the Global Program Team and provide key input to help shape overall program strategy with Atara executive leadership. - Ascertain global program/product strategy requirements from internal sources and external partners, and translate into TechOps-specific planning requirements, resourcing, prioritization, deliverables, etc. - Develop and monitor an integrated program plan, working with the CMC team and key functions to gather key input, interdependencies, and critical path for deliverables. - Ensure all team members understand program/project goals and objectives, current plan and schedule, critical path activities and risks. - As a key interface across different groups, engage stakeholders, facilitate cross-functional decision-making discussions, and ensure timely communication of changes or updates on program to ensure alignment. - Responsible for timely identification of critical path risks and for escalating issues to the appropriate Tech Ops executives, line leaders and/or team members for resolution. - Apply decision analysis tools to analyze complex situations and recommend defensible actions and solutions. - Generate analysis and develop business case(s) to support decisions including for prospective opportunities consistent with the strategic direction of Technical Operations. - Develop tracking dashboards to communicate program updates and identify any critical issues that can impact program. - Recommend and implement innovative process ideas that impact execution and cost efficiency. - Act as cross-functional liaison to ensure program plans remain aligned with current business development strategies. - Partner with Plant Manager, Quality Site Head, Manufacturing, Supply Chain and Engineering leaders to assure timely facility qualification and licensure.
Category
Supply Chain & Op Excellence
ID
2021-1849
Job Locations US-CA-Thousand Oaks | US-CA-South San Francisco
The Executive Assistant will provide a high touch administrative support the EVP, Global Head of Research & Development and the growing Medical Affairs team in a fast-paced environment.   Reports to:   EVP, Global Head of Research & Development Location:     Thousand Oaks, CA or South San Francisco, CA (mix of on-site and remote) Travel:     Minimal   Primary Responsibilities: Under limited supervision and with general direction on priorities from the EVP, Global Head of Research & Development, the position is responsible for the following: - Manages the SVP’s and the teams’ calendars, which includes using judgment to negotiate and maximize managers’ use of time while addressing needs of the organization, as well as anticipating and resolving scheduling conflicts. Keeps team on track with work commitments. - Oversees travel arrangements and plans, including registering leadership team members for conferences and coordinating logistics and itineraries. - Manages and prepares complex expense reports. - Screens calls in order to effectively triage or route to the appropriate internal staff members. - Works cooperatively with other administrative associates. Ensures team members are prepared for project meetings by coordinating and providing all necessary materials as well as supporting managers in developing agendas and documentation as needed. - Establishes and maintains paper and electronic filing systems. Handles sensitive and confidential documentation, including SOP’s, Confidentiality Agreements, and other files relevant to the office so they are properly organized and maintained. - Will be assigned special projects and ad hoc projects or take on additional responsibilities as need including clinical operational coordination and support (i.e., Patient Advocacy coordination). - Maintains a high degree of discretion and confidentiality given the nature of the work.
Category
Administrative
ID
2021-1848
Job Locations US-CA-Thousand Oaks
This Senior Research Associate/ Associate Scientist in Translational Research 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, Translational Research Location      Thousand Oaks, CA Travel       Potential to Travel (up to 10%)   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.
Category
Translational Sciences
ID
2021-1846
Job Locations US-CA-Thousand Oaks
The Validation Sr. Associate works closely with process development and technology transfer to transfer processes from clinical phases to commercial.  The primary responsibility is to validate processes used and to manufacture GMP clinical and commercial products in compliance with GMP regulations.  This position supports the tech transfer and process qualification efforts at our CMO partners and at Atara Thousand Oaks.    Reports to:   Sr Manager, Process Validation Location:       Thousand Oaks, CA Travel:           Travel may be required (up to 10%). Travel may increase if processes are being qualified at CMOs (up to 50% for short periods of time).   Responsibilities - Contributes to development of process validation strategies, protocols and other documentation for Cell Therapy products as well as data analysis and compilation of data and results into summary and final reports. - Leads process validation related activities for the design, qualification, and continued process verification of Atara’s manufacturing processes, including identification of opportunities for improvement.   - Reviews/assesses proposed changes to validated processes via CAPA and Change Control to identify requirements necessary to maintain validated status. - Works with QA to investigate process issues and perform root cause analysis and implement solutions. - Supports Continuous Process Monitoring (CPM) through strong partnership with Process Science, Manufacturing, QC, and QA functions. - Interfaces with other departments (e.g., Engineering, Facilities, Manufacturing, Regulatory Affairs, Quality Control and Quality Assurance) to ensure achievement of Atara’s objectives relating to process validation and associated activities; including compliance with all applicable standards.
Category
Manufacturing
ID
2021-1844
Job Locations US-CA-Thousand Oaks
The Senior Specialist, GMP Learning and Development will help support the GMP Training program for Tech Ops using the company’s Learning Management System (ComplianceWire).  Responsible to deliver effective training to adult learners, multi-task across multiple functional areas, maintain timeline focus and be flexible to meet the demands of a multi-product clinical phase cellular therapy company that is transitioning toward commercial phase.  Ensure compliance to quality standards for documentation, training, and records management.   Location:      Thousand Oaks, CA (mix of on-site and remote work) Reports to:     Manager, Learning and Development Travel:         Limited Travel (up to 10%) Primary Responsibilities: - Partners with management to plan, develop, organize, and execute GMP training development needs. - Conducts needs assessments to evaluate GMP training and training program content adequacy and needs; designs, develops, and delivers training content. - Support internal audits. - Develops curricula design, evaluation of effectiveness, and recommends continuous improvement for ongoing management. - Prepare oral and written communications to management with clarity and accuracy. - Analyzes training trends and reviews quality data to determine opportunities for continuous improvement. - Stays current with applicable regulations including federal, state, local and company-specific practices. - Ensures timely completion and compliance with cGMP and all other relevant company training requirements. - Facilitate instructor led training courses for in-person and/or virtual delivery - Investigate and support training related quality events, such as deviations, CAPAs and change controls
Category
Quality
ID
2021-1843