Scientist/ Sr. Scientist - Upstream Viral Vector Process Development

Company: Atara Biotherapeutics, Inc.
Location: Thousand Oaks
Posted on: June 4, 2021

Job Description:

The Viral Vector Upstream Process Development Scientist/Sr. Scientist is a part of a growing viral vector process development team supporting Atara’s T-cell therapy programs. This role is responsible for planning, performing, analyzing, summarizing, reporting, and presenting experimental results related to Upstream Process development, optimization, tech transfer and troubleshooting. This position works closely with external contract development and manufacturing partners.

The scientist will be also have oversight of external manufacturing of master and working cell banks as well as viral seed stock production, viral vector production, and scale-up. This role authors and reviews technical protocols and reports, drafts batch records and SOPs. The position will support regulatory filings including specifications, validation, comparability, trend analysis, risk assessment, and product quality attributes. The role interacts cross-functionally within the process sciences and analytical organizations, as well as with other departments (regulatory, quality, manufacturing, clinical, supply chain) supporting IND and Marketing Application filings.

The candidate should have successfully demonstrated viral vector process development, production, and analytics, as well as personal attributes including initiative, independent thinking and collaboration skills.

Reports to                    Sr Director Viral Vector Development

Work Location              Thousand Oaks, CA. 

Travel                           Ability to travel up to 25%

Primary Responsibilities:

• Designs and implements viral vector strategies for upstream and downstream process development
• Hands-on work in the developing, executing, and optimizing of upstream (cell culture, scale-up, characterization) unit operations for viral vector production
• Support technology transfer into vector manufacturing
• Works closely with external partners on appropriate viral vector process and characterization studies to enable manufacturing
• Authors and reviews viral vector development and process protocols, reports, and batch records
• Supports virus analytical method development, qualification, transfer, and associated protocols/reports as needed
• Assists with viral vector product quality attribute assessment and scoring to identify critical quality attributes (CQA)
• Supports viral vector process and analytical sections for regulatory filings and response to questions

Education and Experience

Required

• PhD in virology, virus bioengineering, gene/cell therapy, or related field with 2+ years of industry-related experience; or Master’s Degree with 10+ years of related industry experience
• Knowledge and experience in viral vector production, purification, and analytics
• Proficient with large-scale mammalian cell culture and suspension cells
• Ability to design experiments, follow procedures with attention to detail, and successfully execute experiments at the bench
• Project-management skills and ability to work successfully with contracting laboratories and manufacturing facilities
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Demonstrated ability to maintain detailed execution records and perform data analysis

Preferred

• Experience with retroviral and/or lentiviral vectors and adenovirus
• Knowledge or experience with viral vector manufacturing in the biotech industry
• Expertise in virus upstream and downstream process development, such as large-scale suspension cell culture, bioreactors, tangential flow filtration, column purification
• Experience with Design of Experiment (DOE)
• Experience with virus characterization, such as replication-competent virus (RCV), infectious virus bioassays and viral particle assays

Skills and Abilities:

• Experience with viral vector production, purification, and characterization
• Strong communication skills (e.g., clear and concise) and a team player
• Strong time and project management skills
• Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
• Self-motivated and flexible, able to prioritize, multi-task, and work in a fast-paced & demanding environment
• Takes ownership of the assigned project, consulting with management and peers
• Able to understand and interpret data/information and its practical application
• 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.  

Keywords: Atara Biotherapeutics, Inc., Thousand Oaks , Scientist/ Sr. Scientist - Upstream Viral Vector Process Development, Other , Thousand Oaks, California