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-Thousand Oaks
This position works with the Technical Operations teams to develop and/or improve cell assays for cell product characterization and release.  The Research Associate or Senior Research Associate participates in laboratory activities to support process development, evaluate and develop new assay methods, and perform product characterization for Atara’s allogeneic cytotoxic T cell products.  He/she is also involved in assay optimization and standardization and assay transfer to QC team. Under the reasonable supervision, the role includes performing assay development experiments, carefully documenting methods and materials, writing technical reports and communicating findings.  Report to:   Senior Scientist, Analytical Development Location:   Thousand Oaks, California Primary Responsibilities - Develops T-Cell killing assays for evaluating alloreactivity of Atara’s CAR-T cell products. - Plays supporting role in developing other assays for cell therapy product release and characterization. - Supports assay optimization, qualification and validation. - Collaborates with and supports other assay development team members. - Runs routine assays to produce data on behalf of Analytical Development team. - Evaluates reagents and supplies to meet QC standard. - Documents laboratory procedures and experiments with great attention to detail in electronic laboratory notebook (ELN). - Writes technical reports and test methods. - Participates in assay transfer to QC and provides lifecycle supports.
Category
Process Sciences
ID
2021-1737
Job Locations US-CA-Thousand Oaks | US-Remote
This Sr. Manager role supports the Good Clinical Practice (GCP) quality program at Atara Bio. The role helps to execute compliance programs for Atara clinical studies, leads and performs routine audits, and advises Atara personnel on regulations, guidelines and best practices. This position requires an understanding of FDA and international regulations.   Pharmacovigilance and inspection management experience a plus.   Reports to    Director of Clinical Quality Assurance Location       Thousand Oaks, CA (northwest Los Angeles area) or Remote Primary Responsibilities - Helps to implement and execute compliance programs for Atara clinical programs. - Independently plans, conducts and concisely reports results of audits of clinical investigator sites, service providers and internal processes. - Periodically assesses the adequacy of CQA Standard Operating Procedures, with the ability to improve and develop key processes when tasked. - Facilitates capturing, remediation and closure of Quality Issues and any associated CAPAs - Works collaboratively with both internal and external clients to anticipate and resolve quality issues as well as maintain GCP compliance. - Promotes positive work environment by communicating with clearly and collaboratively, provides support to other colleagues, and works in a fashion consistent with Atara Bio values. - Supports any regulatory inspections, should they occur. - Supports other GxP functions as required. Travel           Travel may be required (up to 25%).   Physical Requirements: Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment. Car and plane travel may be a requirement of the role (see above)
Category
Clinical Development
ID
2021-1736
Job Locations US-CA-Thousand Oaks | US-Remote
The Director, Product Quality (CAR-T programs) ensures a consistent quality oversight / approach throughout the Development Process and the Commercial Product Lifecycle across all Atara Allogenic CAR-T products. The Product Quality Leader manages a team who 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.  Represents Quality in Program Teams, and business partner meetings to provide strategic direction and leadership to product development, registration, and approvals. Reports to          Sr. Director Product Quality Leadership Location              Remote OR Thousand Oaks, CA Travel         Up to 20% Primary Responsibilities: - Directs team of PQLs who serves as the quality expert for assigned ATARA CAR-T 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 across programs. - 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 partners and internal CMC teams, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations to enable the Atara allogeneic CAR-T platform. - Ensures strategic management of Quality Risk Management (QRM) for Atara early stage products. - Participates in and supports complex deviation investigations, Material Review Boards, Change Management, Specification Committee, critical quality complaint resolution activities.  - Develops guidance and supports the generation 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 CAR-T product teams are fully aligned around the Quality Strategy. - Partners 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.
Category
Quality
ID
2021-1735
Job Locations US-CA-Thousand Oaks
Position Summary The Senior Specialist, Manufacturing Plant Operations, is a critical leadership position responsible for supporting all operational aspects of Manufacturing. The Senior Specialist works as part of the Manufacturing team delivering on team goals to generate high quality materials used both in the clinical and commercial settings. The Senior Specialist serves as the Manufacturing Owner of activities across Technical Operations and within Atara’s Internal Manufacturing organization and Quality Management System, including:  New Product Introduction, inspection readiness, risk management, and other continuous improvement initiatives.   Reports to:Director, Manufacturing Plant Operations   Location: Thousand Oaks (northwest Los Angeles), CA   Primary Responsibilities - Manufacturing lead responsible for ensuring successful implementation of New Product Introduction - Lead complex, cross-functional, and high visibility sub-teams to advance Manufacturing goals - Provide leadership and direction on manufacturing-related continuous improvement and Operational Excellence projects - Lead and support Manufacturing network development for processes and systems - Partner with Manufacturing, Supply Chain, and Quality teams to identify and drive process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing - Provide input on suitability of technologies, scalability, and manufacturability to Process Sciences during process development activities - Support the implementation of metric and KPI reporting tools as part of Manufacturing’s Integrated Management System - Provide significant technical depth to support troubleshooting efforts and lead high-impact deviation investigations - Contribute to a culture that embraces the safety of the work environment and the safety of patients by complying with company procedures and policies and cGMP biologics cell culture manufacturing requirements - Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients - Work with internal regulatory and quality teams to ensure that all quality and regulatory standards and requirements are implemented and maintained - Drive timely decisions and facilitate active cross-functional technical communication and information flow between team members - Ensure effective risk management processes are implemented to prevent unanticipated failure modes and ensure capability - Work cooperatively with Atara leaders to implement programs to improve overall quality, improve operational efficiency, enhance organizational capability, and assure regulatory compliance - Champion the team mission, vision, and values   Travel: Travel required (up to 10%)
Category
Manufacturing
ID
2021-1732
Job Locations US-CA-Thousand Oaks
The QC Specialist/Sr. Specialist Operations in Business Performance supports activities of Quality Control (QC) relating to new business initiatives, strategic planning, data management, and coordination of QC Operations deliverables.  This role assists and supports the Associate Director, QC Operations to manage and monitor QC testing though the establishment of routine reporting and robust project management framework and business improvement support tools throughout QC.  The position provides support and assistance to reporting and monitoring of key activities for internal management.  Including coordinating the development and implementation of a system to forecast and track testing in QC, from receipt into QC, initiation of testing, completion of testing, and finally reporting.   City:                     Thousand Oaks (Los Angeles) Reports to:           Associate Director, Quality Control   PRIMARY RESPONSIBILITIES - Assist in the coordination of strategic and operational activities within QC including project support, coordination, collation of information, reporting, and data analysis. - Provide support and assistance to the organization to report key performance indicators. - Lead and facilitate periodic tactical meetings with associated testing stakeholders to track testing status. - Partner with testing stakeholders as required to ensure appropriate and timely determination of potential issues impacting testing completion. - Develop and implement procedures for effective data management. - Oversee and manage staff members in the daily use of data systems. - Regularly monitor and evaluate information and data systems that could affect analytical results. - Continually develop data management strategies - Point of contact for Lot status of QC Certificate of Analysis. - Facilitate effective communication across internal departments by trending and reporting data. - Works closely with team members to provide effective solutions to support business and quality objectives. - Defines and analyzes key performance metrics to drive continuous improvement across QC operations. - Support regulatory inspections/audits.
Category
Quality
ID
2021-1731
Job Locations US-CA-Thousand Oaks
Position Summary The Specialist, QC Stability supports the Atara stability program by maintaining short and long-term stability studies in QC.  The QC Specialist is responsible for ensuring timely stability study scheduling, data collection and reporting for QC Stability.  The QC Specialist works within the Atara QC group and is expected to interact regularly and well with manufacturing, regulatory affairs, technical operations, IT, quality assurance (QA) and product quality leadership (PQL) personnel.   Reports to:   Sr. Manager QC Location:       Thousand Oaks (NW Los Angeles area), CA   Responsibilities Draft/revise stability protocols, maintain stability study progress tracker, follow up with testing labs regarding progress, and maintain LIMS stability protocols for cell-based pharmaceutical stability program.    Compile QC stability data packets, data entry, and archive data in accordance with SOPs.    Draft manufacturing sample plans and sample submission forms with guidance from manufacturing and technical operations team to generate stability sample requirements.   Oversee stability sample inventory and work with sample management group for scheduling stability samples to contract labs.   Provides guidance to QC associates supporting stability and related activities.    Author, execute, review, and approve procedural SOP and stability protocols and reports.   Supports internal and external inspections and audits.   Works with QA/PQL to investigate problems, performs root cause analysis, and implements solutions.   Travel:      10%
Category
Quality
ID
2021-1730
Job Locations US-CA-Thousand Oaks
This Research Associate /Senior Research Associate - Analytical Development position works with the Technical Operations teams to develop and/or improve cell assays for cell product characterization and release.  The senior research associate or associate scientist participates in laboratory activities to evaluate, develop, qualify 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, writing technical reports and communicating findings.    Reports to         Senior Scientist of Analytical Development   Work 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. - Document’s 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
2021-1729
Job Locations US-CA-Thousand Oaks
The Sr. Engineer – Technical Services supports the technical activities associated with T-cell manufacturing across the Atara manufacturing network.  This position provides on-the-floor manufacturing support to address deviations, support change control and CAPA, as well as support process monitoring, technology transfer, and manufacturing process troubleshooting as needed.  Qualified candidates will have demonstrated technical proficiency in cell therapy manufacturing, a strong understanding of cGMP, initiative and effective collaboration with others.   Work Location:      Thousand Oaks, CA Reports to:            Director, Technical Services   Position Responsibilities - Performs technical assessments (Product Impact Assessments, PIAs) for deviations; supports and/or owns change controls and CAPAs. - Supports investigations of process failures. - Owns and provides technical expertise in FMEA; supports and provides technical expertise for HAZOP related activities to support quality by design (QBD). - Authors, reviews and edits manufacturing documents including SOPs, batch records, specifications as necessitated by process changes. - Reviews and edits executed batch records, validation protocols and reports to assure appropriate and complete content. - Supports maintenance of process monitoring database; supports parameter tracking and trending activities; presents routine process monitoring updates from analyses on production data. - Supervises and performs development and manufacturing support work for internal and external manufacturing cleanroom processes and production areas, including process characterization studies, process engineering (improvement) activities and validation. - Supports training of internal and external manufacturing staff. - Supervises temporary and/or contingent staff working in technical services. - In collaboration with other development functions at Atara, assures effective transfers and start-up of new processes across Atara manufacturing network. - Serves as a role model for Atara’s Values of patients first, innovation teamwork, community, and mindset.   Travel Travel required (up to 30%) initially to support our work with our CMO collaborator on company paid domestic travel in 2 week (minimal) rotational intervals.  Support local manufacturing in Thousand Oaks and support the rotational schedule of at least two weeks at the CMO for up to 12 months (duration subject to change).
Category
Manufacturing
ID
2021-1728
Job Locations US-CA-Thousand Oaks
The QC Manager, Microbiology provides management and oversight of the QC Microbiology department ensuring that staff are trained and resourced to execute their duties in a reliable and compliant manner supporting in-process testing and environmental monitoring, personnel monitoring, gowning qualification, and utility testing.  This position is also responsible for ensuring adequate resources and oversight of the non-routine method qualification and studies, area requalification, growth promotion and media testing.   Reports to:            Director, QC Microbiology Location:               Thousand Oaks, CA Travel:                   Less than 10% Shift:                      This role will support a 5 day/8-hour work schedule. Either Sunday – Thursday or Tuesday – Saturday or Monday – Friday shifts. Primary Responsibilities - Ensure that EM Data Trending is performed on a timely manner and escalate EM Trends as necessary. - Oversee daily microbial testing activities to support the development and manufacture of drug/device products. - Manage the environmental monitoring (EM) program, compressed gas monitoring program, gowning qualification, and microbiological testing. - Ensure that lab and environmental monitoring activities are conducted according to safety guidelines, policies, and legislation. - Review quality documentation of the QC Microbiology Department. - Manage alert and action level and other events investigations. - Maintain quality and quantity of departmental work through initial and continued training and oversight of lab staff; propose additional or customized training to lab management according to need. - Support audits of Microbiology during regulatory inspections. - Write/support investigation reports as needed. - Write, review, and implement QC protocols for test method qualification/validation, SOPs and other quality processes such as LIMS. - Participate in quality testing procedure’s development or improvement. - Ensure GMP compliance in the QC laboratory; update procedures and improve as needed. - Ensure analytical instrument’s maintenance and calibration under cGMP regulation. - Train QC personnel on quality procedures. - Apply knowledge of good manufacturing practices and good laboratory practices daily. - Perform GMP audits of laboratories, as appropriate. - Note: The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.   Physical Requirements - Subject to extended periods of sitting and/or standing in a laboratory environment. - Ability to lift 50 lbs. and to work in controlled space laboratory required. - Ability to reach above the shoulder and bend to be able to gown.
Category
Tech Ops
ID
2021-1727
Job Locations US-CA-Thousand Oaks
The QC Supervisor, Microbiology provides supervision and oversight of routine and non-routine microbiological activities.  This included scheduling and execution of the environmental monitoring program, gowning qualification and personnel monitoring program, compressed gases testing program and in-process and product release testing requirements. This position is also responsible for ensuring adequate resources and oversight of the non-routine method qualification and studies, area requalification, growth promotion and media testing.   Reports to:            Director, QC Microbiology Location:               Thousand Oaks, CA Travel:                   Less than 10% Shift:                      This role will support a 5 day/8-hour work schedule. Either Sunday – Thursday or Tues – Saturday shifts. Primary Responsibilities - Ensure that lab and environmental monitoring activities are conducted according to safety guidelines and policies. - Responsible for scheduling, review and quality documentation of the environmental monitoring program as well as utility program. Provides support for alert and action level event investigations. - Maintain quality and quantity of departmental work through initial and continued training and oversight of lab staff; propose additional or customized training to lab management according to need. - Responsible for scheduling, execution and testing of media, EM testing, in-process, and product release testing. Provides support for quality investigations. - Provide environmental monitoring support for aseptic processes. - Perform/Support gowning qualification of personnel. - Responsible for scheduling and execution of test data review in a timely manner. - Ensure equipment and materials needed to support environmental and utility monitoring programs are procured, tested and available for use. Provides support needed for the investigation of malfunction of equipment. - Perform administrative duties such as approval of time documentation. - Responsible for professional development, goal setting and performance review of lab staff. - Provide information in support of department budget.  Contribute to departmental strategy and provide input on lab requirements and improvements. - Provide support for investigations and CAPA implementation. Note: The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.   Physical Requirements - Subject to extended periods of sitting and/or standing in a laboratory environment. - Ability to lift 50 lbs. and to work in controlled space laboratory required. - Ability to reach above the shoulder and bend to be able to gown.
Category
Tech Ops
ID
2021-1725
Job Locations US-CA-Thousand Oaks
This position supports all regulatory affairs activities for the company’s products, including but not limited to collecting and summarizing regulatory intelligence, performing regulatory assessments, participation in project teams, providing input for regulatory submissions, and managing the compilation and review of all submissions for completeness and quality.   Reports to:  VP, Global Regulatory Affairs Location:    Thousand Oaks, CA Travel:         Travel may be required (up to 10%)   Primary Responsibilities - Manage regulatory projects and closely collaborate with Clinical, Regulatory Operations, other scientific and technical departments and external vendors to coordinate and implement submission strategy and content in a global clinical bio-pharmaceutical development environment. - Provide updates on strategic regulatory intelligence, such as new regulations, guidance, ODACs, competitive product applications and approvals, etc. - Provide regulatory intelligence to inform regulatory strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios. - Provide tactical support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original BLAs and international Marketing Authorization Applications and their respective amendments/supplements. - Coordinate and manage regulatory submission documents (e.g., cover letters, Meeting Requests, Meeting Briefing Packages, etc.) to produce submission ready content. Coordinate interdepartmental team review and approval of submission document deliverables including: distribute drafts, attend/steer review meetings, and incorporate revisions. - Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems such as Veeva, as appropriate. - Work with Regulatory Operations or publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring that Atara’s practices are in conformance with the latest health authority and industry submission standards. - Assist with logging, tracking and filing of correspondence with regulatory authorities and ensuring that no commitment remains unduly outstanding.
Category
R&D Ops
ID
2021-1724
Job Locations US-CA-Thousand Oaks
Position Summary 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 to facilitate transfer to our Thousand Oaks cell therapy facility.    Reports to:   Validation Specialist, Technical Services Location:       Thousand Oaks (NW Los Angeles area), CA    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, Change Control and Work Orders 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 Verification (CPV) 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.  Travel:        To make sure we’re up and running well, we’re asking team members for this role to travel up to 50% of the time for the first 3-6 months, shuttling between Southern California and outside of California on company paid travel to work with our contract manufacturing partner. The goal is to learn the ins and outs of our cell therapy manufacturing process before we bring it in-house with the new facility in Thousand Oaks. After that first 3-6 months? Travel may be required (up to 10%).
Category
Manufacturing
ID
2021-1723
Job Locations US-CA-Thousand Oaks
The Facilities/Equipment Asset Specialist will be responsible for managing Atara’s asset management lifecycle program.  The program covers all aspects of owned and leased assets from acquisition to disposition at Atara Biotherapeutics.  This position works cross functionally to ensure all GMP and Non-GMP assets follow the company’s asset lifecycle management policy.   Reports to      Associate Director, Facilities and Engineering Location         Thousand Oaks (northwest Los Angeles area), CA Travel             Up to 10%   Responsibilities - Monitor/track the acquisition and disposition of all company assets. - Ensure introduction of new assets is conducted following company policies and requirements. - Maintain good control of asset documentation and ensure information is current and accurate. - Create, maintain, and update asset lifecycle policy, operational procedures, and forms. - Collaborate with equipment owners and other functional groups on the process for the acquisition, operation, maintenance, and disposition of assets. - Participate in capital projects and provide guidance on the applicable requirements for asset management. - Collects asset information and create reports to present to management. - Execute small capital projects. - Supervise contractors and/or third-party vendors. - Performs other duties as assigned.
Category
Tech Ops
ID
2021-1721
Job Locations US-CA-Thousand Oaks
The Viral Vector Process Development Associate Scientist is part of a growing Virology Team and is responsible for viral vector process development and analytics assays supporting Atara’s immunotherapy programs.   This role will primarily be expected to perform laboratory studies, collect and analyze data, and development of new assays for the characterization of vector and vector producing cells. This work will include process development and scale-up, data analysis and interpretation, authoring protocols / SOPs, drafting and managing work-streams / schedules, adhering closely to established procedures and policies, and maintaining impeccable documentation of work performed. 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, bioreactor development, and analytical development 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: Sr. 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 - Participate in selection and screening process for precursor candidates of cell banks - Training and becoming qualified on characterization assays - Flow cytometry analysis of stained cells - Various immunostaining assays for characterization of mammalian cells - Perform virus infections in 96-well plates - Maintain very accurate pipetting skills while performing dilution series - Quantitative PCR on both DNA and RNA samples - Isolation of DNA and RNA samples using commercially available kits - Basic analysis of genetic sequences for plasmids, viruses, and cells - Works closely with external partners on characterization and release studies - Supports virus analytical method development, transfer, and technical reports as needed - Maintain detailed documentation of laboratory procedures, experiment methods, and data collection - Adheres to SOPs and protocols with no deviations - 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 - Assist in writing technical reports, protocols/SOPs, and Tech-Transfer documents - Read and understand relevant literature and be able to extrapolate key information and/or techniques that may be utilized for developmental work - Evaluate and prepare data slides and conclusions to communicate to the program team - Maintain relationships with vendor representatives as necessary - Complete all company compliance trainings on-time - 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
2021-1720
Job Locations US-CA-Thousand Oaks
The S&OP Planner is responsible for developing and executing short and long term supply plans for Allogeneic cell therapy products. The S&OP Planner will orchestrate the manufacturing of multiple products across multiple sites (internal and external) with the primary goal of ensuring supply of Atara’s cell therapy portfolio. We are looking for a self-directed supply chain expert to work cross-functionally with both internal and external partners to orchestrate supply against clinical & commercial demand.   Reports to: Director, Sales & Operations Planning, Supply Chain Location: Thousand Oaks, CA Travel: N/A   Position Responsibilities: - Develops and manages end-to-end T-cell supply plans to ensure seamless supply of starting materials, manufacturing of intermediates and final product, and on-time delivery to clinical & commercial sites. - Responsible for developing and executing T-cell therapy raw material, intermediate and final product supply plans against forecasted and realized demand. - Supports the Sales and Operations Planning process including development and maintenance of planning cycles in support of demand and supply plans. - Coordinates with internal teams/stakeholders, strategic partners and CMOs to ensure product manufacturing plan is clear and executable. - Consolidate and analyzes inputs/assumptions to ensure a robust plan. - Promptly identifies, escalates and resolves issues and mitigate risks to clinical supply. - Develops and implements tools/software to enable supply chain planning for Atara’s clinical trials & commercial supply. - Develops and owns supply planning procedures for supply chain operations and related activities. - Interfaces throughout the organization, including Senior Management. - Define and analyze key performance metrics to drive continuous improvement in reliability, cost, and speed of the supply chain. - Develops long term supply plans to support the long-range planning process - Support and engage in quality records through Atara’s Quality Management Systems
Category
Manufacturing
ID
2021-1719
Job Locations US-CA-Thousand Oaks
As a Sr. Specialist QA, you will be a part of the Quality Systems & Compliance team based in Thousand Oaks, California.  As the Business Process Owner, you will have the overall responsibility to develop, implement and sustain the Atara Quality Audit Program ensuring compliance with internal requirements and external GMP regulations.  Responsible for a high level of understanding of the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating, and reporting to determine a quality system's adequacy and deficiencies. Partner with business functions to ensure the successful implementation of the Audit Program. This role will require the strategic capability in the form of program development and ownership (including policies, procedures, leading governance, and quality performance monitoring efforts, etc.). In addition to serving as a subject matter expert in these areas, you will be responsible for maintaining strong, collaborative partnerships with cross-functional and cross-site team members and to create a successful program which would include but not be limited to, Internal, External (Partner), Supplier, Regulatory Body, and Clinical Audits.   Work Location            Thousand Oaks, CA Reports to                  Director, Quality Systems & Compliance Travel                         Travel required (up to 10%) Primary Responsibilities - Responsible for implementation and maintenance of the Atara audit program - Responsible for the overall audit processes and assuring consistency across the audit program. - Develop and maintain phase-appropriate Quality processes, with respect to product lifecycle stages from non-clinical development through the life of the program, including commercial launch, and post market approval. - Ensure Internal Quality Audits, Supplier/Service Provider Audits, Contract Manufacturing Organizations and Contract Test Laboratory Audits are established, scheduled, and adhered to. - Responsible to be the in-room audit manager for all regulatory and external audits. - Lead, develop and implement regulatory inspection readiness activities. - Ensure inspection readiness of all internal and external entities in preparation of competent authority inspections. - Collaborate with all Atara Quality Operations team to assure all applicable groups are inspection ready and operate in a complaint manner with applicable regulatory guidance. - Responsible for the development and training of a cross functional audit cadre to execute and complete appropriate audit activities. - Perform periodic reviews of Audit Program documents to ensure the files remain reflective of data/trending signals and ongoing activities. - Support routine Quality processes such as investigating non-conformances, CAPAs, complaints, other process monitoring activities. - Assists in risk assessment process and preparation of audit plan that focuses on high-risk areas. - Establish and maintain strong and efficient communication lines to ensure audit findings are communicated, timely execution of corrective action and implementation of efficiency gains and process improvements. - Partner with Information Technologies (IT) to define the requirements for Quality electronic systems/databases as the Business Owner, and co-lead implementation of these requirements. - Act as subject matter expert (SME) of Audit Program, with responsibilities that include defining Key Performance Indicators (KPIs), monitoring system performance, and ensuring compliance to requirements and reporting during QMR.  - Measures and tracks the results of audits performed through action plan follow-up procedures. - Manage the development of responses to observations for external inspections and audits. - Provide recommendations for continuous improvement to strengthen the internal processes and structure. - Can function as a lead auditor for internal audits and perform audits to ensure compliance to internal and external requirements.
Category
Quality
ID
2021-1717
Job Locations US-CA-Thousand Oaks
The Viral Vector Process Development Senior Research Associate will be part of a growing Virology Team and will assist with viral vector process development and analytics assays supporting Atara’s immunotherapy programs.   This role will primarily be expected to perform laboratory studies, collect and analyze data, draft and edit protocols, adhere closely to established procedures, and maintain impeccable documentation of experiments performed. This position will have the opportunity to collaborate across three different work-streams for Viral Vector Development:  cell engineering; upstream process development; and downstream process development.   The candidate should be very organized, able to follow instructions faithfully and have competitive personal attributes including initiative, independent thinking, and collaboration skills.   Reports to:    Sr. Scientist – Viral Vector Development   Location:       Thousand Oaks (northwest Greater Los Angeles area), CA    Position Responsibilities - Mammalian cell culture; both adherent and suspension - Very good aseptic technique - Characterization of protein / virus producing cell lines - Participate in selection and screening process for precursor candidates of cell banks - Training and becoming qualified on characterization assays - Flow cytometry analysis of stained cells - Various immunostaining assays for characterization of mammalian cells - Perform virus infections in 96-well plates - Maintain very accurate pipetting skills while performing dilution series - Quantitative PCR on both DNA and RNA samples - Isolation of DNA and RNA samples using commercially available kits - Maintain detailed documentation of laboratory procedures, experiment methods, and data collection - Adheres to SOPs and protocols with no deviations - Multi-tasking project schedule and study deliverables - Assist in writing technical protocols and data capture sheets - Complete all company compliance trainings on-time - 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
2021-1716
Job Locations US-CA-Thousand Oaks
The Viral Vector Process Development Scientist is part of a growing Virology Team and is responsible for viral vector process and analytical development supporting Atara’s immunotherapy programs.   This role is primarily responsible for performing laboratory work and development work supporting the engineering and production of cell banks. This work will include process development and scale-up, data analysis and interpretation, authoring protocols / SOPs, drafting and managing work-streams / schedules, adhering closely to established procedures and policies, and maintaining impeccable documentation of work performed. 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 regulatory, quality, manufacturing, and supply chain).   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:       Sr. Scientist – Viral Vector Development   Location: Thousand Oaks (northwest Greater Los Angeles area), CA    Position Responsibilities - Design and implement strategies for cell engineering - Large scale mammalian adherent cell culture - Aseptic technique suitable for highly controlled tissue culture work - Generation, and characterization of cell banks and virus banks - Execute selection and screening studies, including subcloning and genetic stability - Basic analysis of genetic sequences for plasmids, viruses, and cells - Works closely with external partners on characterization and release studies - Supports virus analytical method development, transfer, and technical reports as needed - Maintain detailed documentation of procedures, experiment methods, and data collection - Adheres to SOPs and protocols with no deviations - Maintain compliance with quality guidelines for the Cell Engineering Laboratory - 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 - Assist in writing technical reports, protocols/SOPs, and Tech-Transfer documents - Read and understand relevant literature and be able to extrapolate key information and/or techniques that may be utilized for developmental work - Evaluate and prepare data slides and conclusions to communicate to the program team - Maintain relationships with vendor representatives as necessary - Complete all company compliance trainings on-time - 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
2021-1714
Job Locations US-CA-Thousand Oaks | US-CA-South San Francisco
We are seeking a highly motivated individual to join us as Associate Director, Indirect Procurement & Strategic Sourcing.   The successful candidate will lead sourcing and procurement activities primarily in support of Indirect categories (e.g. IT, Commercial, HR, and Consulting services).  Responsibilities for this role will include sourcing category strategy development and project execution.  This role will be hands-on reporting to our Senior Director, Procurement & Strategic Sourcing.  Activities will include category sourcing project execution (e.g., RFI, RFPs, RFQs), strategy development, supply market analysis, risk management, contract negotiations, and supplier relationship management.  Reports to: Sr. Director, Procurement & Strategic Sourcing Travel: Willing to travel as required (up to 30%) Location: Thousand Oaks, CA or South San Francisco Responsibilities - Leads sourcing initiatives including requests for proposals, supplier selection, and negotiations. - Partners with IT, Commercial, and Human Resources among other functions to develop business requirements and execute sourcing initiatives. - Develops a deep understanding of business partner objectives to ensure alignment with sourcing initiatives. - Develops and executes sourcing category strategies using data analysis, risk assessments, internal customer needs and supplier landscape knowledge. - Develops sourcing strategies to ensure continuous supply with minimal risk and improved pricing and product quality. - Leads development and execution of a supplier relationship management framework. - Drives continuous improvement within Sourcing and Procurement processes by leveraging Operational Excellence tools and resources.
Category
Finance
ID
2021-1713
Job Locations US-CA-Thousand Oaks | US-Remote
This position supports 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 or intermediates throughout the product lifecycle working closely with the product teams and partners.    Reports to:          Director Product Quality Leadership Location:             Thousand Oaks, CA OR Remote Travel:                 Up to 20%     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. - 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 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.  - Represents Quality in CMC Team, Program Team, and business partner meetings to provide strategic direction and 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.
Category
Quality
ID
2021-1712