Atara Biotherapeutics, Inc. Manager/Sr. Manager, Quality Control, Bioanalytical in Thousand Oaks, California
The Manager/Sr Manager, Quality Control role manages a team of individuals and activities for Atara’s Quality Control Bioanalytical laboratories, including raw material, in-process, stability, and product release testing. Position requires both leadership and technical expertise. The candidate must have GMP laboratory and bioassay, cell biology or immunology experience. The selected individual will need to lead, develop, train, and motivate staff. This requires a self-motivated, detailed oriented, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment. From a technical perspective, the selected individual will directly oversee daily testing activities, investigations, QC equipment implementation and maintenance, method qualification/transfers and validation activities.
Reports to: Sr Director, Quality Control
Location: Thousand Oaks, CA
Travel: Up to 10%
Manage Quality Control activities at Atara’s ATOM Quality Control Bioanalytical laboratories, including raw material, in-process, stability, and product release testing.
Lead and develop a team of QC Associates/Sr Associates in alignment with Atara and department objectives.
Author, review, and approve laboratory procedures, protocols and reports.
Support cGMP manufacture and supply of high-quality cell therapy products.
Oversee implementation of new analytical methods at QC, including qualification, transfer, and validation strategies for Atara’s cell therapy products.
Assess analytical method performance and investigate assay trends.
Participate in laboratory investigations including Unexpected Results (UR)/Out of Specification (OOS), root cause analysis and implement solutions.
Identify and implement corrective/preventive actions.
Review and assess proposed changes to assays and/or QC equipment via CAPA, Change Control and Work Orders.
Implement phase-appropriate QC capabilities, business processes, and procedures.
Maintain current knowledge base of regulations and policies to ensure that the QC function remains in compliance with applicable company requirements and global regulations.
Interfaces with other departments (e.g., Facilities, Information Technologies, Manufacturing, Regulatory Affairs, and Quality Assurance) to ensure achievement of Atara’s objectives relating to QC analytical method readiness for new product introductions, including compliance with all applicable standards.
Bachelor’s Degree in Biochemistry, Molecular and Cellular Biology, Immunology, or Biology with 10+ years of experience OR an equivalent combination of education and experience.
Requires 5+ years of experience supervising/managing direct reports.
Experience leading projects with history of achieving results and outstanding outcomes.
Experience in analytical method qualification, transfer, and validation
Experience in cGMP cell therapy manufacturing and/or testing facility is a plus.
Advanced knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues.
Independent decision-making capability and ability to think conceptually and understand impact of decisions critical.
Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
Must possess excellent verbal and written communication skills, good interpersonal skills.
Knowledge of and the ability to implement CFR, USP, and ICH requirements is required.
Laboratory investigation, OOS, and root cause analysis experience is required.
Strong communication skills, team player, and proven negotiation skills.
Ability to lead, manage and motivate staff.
Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
Flexibility to travel as required to accommodate the business needs.
Ability to identify and implement improvement opportunities.
Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust).
We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options. We are considered a leading off-the-shelf T-cell immunotherapy company (Nasdaq ATRA) developing novel treatments for patients with cancer, autoimmune and viral diseases.
We’re proud of our team of 425+ Atarians co-located by design in 4 different locations including South San Francisco (corporate headquarters), Thousand Oaks (R&D and manufacturing headquarters), Zug, Switzerland (european headquarters) and a R&D site in the Denver, Colorado area. Our Southern California hub is anchored by a new 90,000 sq. ft., state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility.
Our mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork, and a commitment to excellence.”
Our vision - “T-Cell Immunotherapy for every patient, any time.”
Atara offers a competitive benefits packages that includes medical/dental/vision benefits, life and disability, retirement and stock program, as well as a generous paid time off and wellness plan that supports the well-being of our staff. Visit www.atarabio.com/careers to learn more.
Atara Bio is an equal opportunity employer and makes employment decisions on the basis of merit and other lawful factors. In accordance with applicable law, the Company prohibits discrimination based on race, color, religion, creed, sex, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity, expression or dysphoria, marital status, age, national origin or ancestry, physical or mental disability, medical condition, genetic information, veteran status, caregiver status, sexual orientation, transgender status or any other classification protected by federal, state or local laws or because of the individual’s association with a member of a protected group or connection to an organization or group related to a protected group.
We comply with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Atara Bio in the United States.
Job ID: 2021-1734
External Company Name: Atara Biotherapeutics, Inc.
External Company URL: https://www.atarabio.com/