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.”
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This role works with the Platform Science & Development teams to develop and improve cell therapy manufacturing processes. The RA/Sr. RA will participate in laboratory activities to support process development, product characterization, and cell reagent production for Atara’s cytotoxic T cell products. Responsible for cell culture media preparation, cell culture, analytical cell reagent preparation, and stocking and maintaining the PD laboratories. Under minimal supervision, expected to assist in experiments, carefully document method and materials, and communicate findings. The position is based out of the Process Development lab at the Fitzsimons Innovation Campus in Aurora, CO.
Reports to: Manager, Process Development
Location: Aurora, CO
- Contributes to the production of a comprehensive library of antigen presenting cells as assay reagents.
- Perform testing of intermediate cell materials to assess their suitability for use in manufacturing.
- Sets up, monitors, samples, and analyzes cell culture processes.
- Assists in maintaining laboratory, monitoring lab inventory, and ordering supplies.
- Documents laboratory procedures and experiments with great attention to detail in laboratory notebooks.
- Provides support for the development of manufacturing processes for cell therapy products.
- Assists in process development studies to develop a thorough understanding of operating and performance parameters (design space).
The Engineering Technical Services team supports the technical activities associated with T-cell manufacturing across the Atara manufacturing network. The Senior Engineer, Tech Services will primarily be responsible for providing process technical support and subject matter expertise for late stage and commercial products. This includes working with various functional areas leading the efforts, developing, and building related program processes, and driving the development of and owning the Atara particulate management program. Additionally, as required, this individual will provide on-the-floor manufacturing support to address critical deviations, support change controls and CAPAs, as well as support process monitoring, technology transfer, and manufacturing process troubleshooting. Qualified candidates will have demonstrated technical proficiency in cell therapy manufacturing, project management experience, a strong understanding of cGMP, initiative, and effective collaboration with others.
Reports to Director, Technical Services
Work Location Thousand Oaks, CA (Hybrid/Flex)
Travel Travel required (up to 30%)
- Optimizes late stage and commercial processes to increase yield maximize capacity, reduce costs, and decrease process variability while maintaining regulatory compliance.
- Provides technical leadership in investigations to determine root cause and implement appropriate corrective and preventive actions.
- Executes laboratory runs and authors technical reports summarizing results, generating necessary data to support product impact assessments during discrepancies and investigations.
- Supports change management and implementation activities for changes to the manufacturing processes and associated systems.
- Provides technical support for equipment and process validation activities.
- Develops, establishes, and owns a company-wide particulate matter management program in collaboration with Quality, Material Sciences and Process Sciences/Early Platform Development.
- Owns and provides technical expertise in FMEA; supports and provides technical expertise for HAZOP related activities to support quality by design (QBD).
- Review and provide technical input or support for regulatory filings, regulatory inspections or projects for regulatory commitments.
- Can perform technical assessments (Product Impact Assessments, PIAs) for deviations; supports and/or owns change controls and CAPAs.
- Can support investigations of process failures.
- May author, review, and edit manufacturing documents including SOPs, batch records, specifications as necessitated by process changes.
- May review and edit executed batch records, validation protocols and reports to assure appropriate and complete content.
- May support maintenance of process monitoring database; supports parameter tracking and trending activities; presents routine process monitoring updates from analyses on production data.
- May supervise and perform 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.
- May support training of internal and external manufacturing staff.
- Potential to 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.
- Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust)
The Sr.MedicalDirector, Drug Safety & Pharmacovigilance provides hands-on and strategic input for PV activities associated with investigational and commercial stage products. This individual has a highly visible role across all levels of management and functional areas.
Reports to Vice President, Drug Safety & Pharmacovigilance
Location Thousand Oaks, CA (Hybrid/Flex) or Remote
Travel Up to 15%
- Medical safety expert for products.
- Signal detection, signal investigation and assessment, literature review, proactive management of the benefit-risk profile for assigned products and any resultant activities such as revisions to core safety information.
- Risk management activities, including risk strategies for assets in all phases of development and life-cycle.
- Routine PV activities of assigned programs including medical review, analysis of similar events, and literature review.
- Coding reviews and reconciliation activities in collaboration with Data Management.
- Coordination and project management of aggregate safety reports (e.g. PSURs/PBRERs, PADERs).
- Contribution to safety sections of key documents (e.g. protocols, ICFs, IBs, RMPs, CDS, labels, INDs).
- Contribution to regulatory submission documents, response to queries and other regulatory enquiries.
- Performs aggregate analyses of specific events across studies, prepares and presents safety analyses at the Safety Committees, and writes Safety Assessment Reports.
- Interacts with contract vendors (case processing, call center, etc.) to resolve safety-related issues.
- Contributes to Post Authorization Safety Studies (PASS) and safety registries.
- Reviews Safety Data Exchange Agreements as applicable.
- Supports the safety department in organizing post-marketing activities in all applicable regions.
- Contributes to and reviews SOPs.
- Serves as a PV Safety contact to other Atara’s departments, EU QPPV, clinical sites, vendors and partners.
- Prepares for regulatory inspections and audits and develops corrective action plans when needed.
- Prepares training material for internal and external safety presentations (e.g. investigators meetings, SIVs).
- Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust).
- Other activities as needed, such as performing cell selection (after specific training) for patient-product matching requirements.