Senior Scientist - Viral Vector Process Development
Process Sciences Thousand Oaks, California
The Viral Vector Process Development Senior Scientist / Scientist is a part of a growing Virology Team and is responsible for viral vector process and analytical development supporting Atara’s T-cell therapy programs.
This role is responsible for designing and implementing viral vector strategies for upstream and downstream process development. This position works closely with external contract laboratories on viral vector studies to support external manufacturing. The person also transfers viral processes and assays in-house and performs laboratory studies.
This position includes master and working cell bank and viral seed stock production, viral vector production and purification, virus process development and scale-up, development of in-process controls and virus analytical methods to support manufacturing and lot release, managing experimental plans and schedules, experimental design, statistical data analysis, and interpretation. This role authors technical protocols and reports, drafts batch records and SOPs. The position also reviews 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.
Reporting Relationship and Work Location:
This position, based in Thousand Oaks (NW Los Angeles area), CA Reports to the Associate Director, Viral Vector Process and Analytics.
- Designs and implements viral vector strategies for upstream and downstream process development
- Works closely with external partners on appropriate viral vector process and characterization studies to enable manufacturing
- Transfers and executes viral vector laboratory procedures and assays in-house as required
- 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
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
Education and Experience
- PhD in virology, virus bioengineering, or gene/cell therapy with 5+ years of industry-related experience; or Master’s Degree with 10+ years of related industry experience; or Bachelor’s Degree with 15+ years of 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
- Experience with adenoviral vector a strong benefit
- Experience desired with retroviral and/or lentiviral vectors
- 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
Ability to travel up to 10%
Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is approximately 50% lab based and 50% office based.
More About Atara Bio
Now in our sixth year, we’re proud of our team of 260+ Atarians co-located by design in South San Francisco (corporate headquarters) and Southern California (R&D and manufacturing headquarters in the northwest Los Angeles area) with a newly-established European headquarters in Zug, Switzerland. Atara also has a R&D site in the Denver, Colorado area and an office in New York City. 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 in Thousand Oaks, California.
One mission – “Transform the lives of patients with serious medical conditions through pioneering science, teamwork and expertise” – and a singular vision – “Cell therapy treatment for every patient, any time – provide inspiration and direction for all of us.”
The Company's off-the-shelf, allogeneic T-cells are bioengineered from donors with healthy immune function and allow for rapid delivery from inventory to patients without a requirement for pretreatment. Atara's T-cell immunotherapies are designed to precisely recognize and eliminate cancerous or diseased cells without affecting normal, healthy cells.
Atara's most advanced T-cell immunotherapy in development, tabelecleucel, or tab-cel™ (formerly known as ATA129), is being developed for the treatment of patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab, as well as other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical development for the treatment of EBV+ PTLD following an allogeneic hematopoietic cell transplant (MATCH study) or solid organ transplant (ALLELE study).
Atara is also developing off-the-shelf, allogeneic ATA188 and autologous ATA190 T-cell immunotherapies using a complementary targeted antigen recognition technology for specific EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). A Phase 1 clinical study of autologous ATA190 in patients with progressive MS is ongoing. Atara is also advancing a Phase 1 clinical study of ATA188 in patients with progressive or relapsing-remitting MS across clinical sites in the United States and Australia. Atara's clinical pipeline also includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed against cytomegalovirus (CMV).
Working at Atara Bio
People at Atara Bio are high integrity, roll-up-your-sleeves, get-it-done types who are keenly committed to putting patients first, advancing medical care and doing so with demonstrated urgency. At their core Atarians are people who work well with others and are “team-centric”, have purposeful curiosity and can’t wait to save patient lives. And similar to other biotech companies who have so many accomplished people, we expect humility (we are a “low hubris” sort of place), flexibility, respect, teamwork, good judgment and getting the most out of any dollar we spend. We also expect to enjoy the journey (and each other) as we move forward with a shared responsibility to teach and to learn from what we do and from our teammates.
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.