Senior Director, Analytical Development - Allogeneic and Autologous T-cell products
The Senior Director, Analytical Development leads analytical development function and staff in support of product and platform development for Atara allogeneic and autologous T-cell therapies. Responsibilities include establishing and managing work plans to achieve goals for analytical method development across all T-cell therapy products, including application of methods to stability and comparability protocols. The director will assure lot release and characterization assays are developed and implemented in compliance with FDA regulations and other jurisdictions and will assure appropriate method qualification and transfer to QC, and support validation. The director will author and/or review method sections of CMC regulatory submissions and communications and represent the analytical function in regulatory interactions. The role requires breadth of experience across analytical functions and a history of regulatory interactions regarding parenteral product development. Importantly, the director will have experience developing assays to quantify strength, purity and potency of cell therapy products, preferably engineered T cells. The successful candidate must have successfully demonstrated leadership, technical proficiency, scientific creativity, initiative and collaboration with others.
Reports to: VP, Process Sciences
Location: Thousand Oaks (northwest Los Angeles area), CA
- Serves as the technical and strategic expert in method development for strength, purity and potency attributes of T-cell therapy product for purposes of product lot release and characterization in association with a GMP manufacturing environment.
- Establishes, communicates and manages project plans and timelines for phase-appropriate method development, qualification, transfer to QC and validation support.
- Shapes approach and policies for developing and establishing analytical methods.
- Provides technical and GMP compliance guidance to cross-functional teams in support of project goals.
- Represents the analytical development function for authoring, reviewing and approval of GMP and regulatory documents as appropriate, including SOPs, protocols, reports, specifications, QTPPs, risk and impact assessment, and filing sections.
- Collaborates with Atara Process Development, Manufacturing, Quality and Regulatory functions as well as with functional leads of external partners to maintain alignment of goals and to navigate project obstacles.
- Strategizes and leads/supervises communications with regulatory agencies regarding analytical subject matter.
- Leads project sub-teams and working groups and may serve as Technical Project Lead representing Technical Operations on product teams.
- Hires, supervises and mentors scientific staff.
Travel required (up to 25%).
- Advanced degree in a biological science with 15+ years of relevant experience in biologics development including cell therapy development and late-stage product development; PhD (preferred).
- Fundamental knowledge in cell biology, immunology, cell culture, cell-based assays and assays standard to cell therapy product characterization.
- Breadth of knowledge across analytical method development, method validation, cGMP, Quality Systems and regulatory requirements for biologics including cell therapies.
- Demonstrated in-depth skills in designing, executing, interpreting and documenting experiments.
- Experience authoring methods and characterization sections of CMC regulatory documents.
- Supervisory experience
- Demonstration of strong communication skills, leadership skills and ability to effectively influence others.
More About Atara Bio:
Now in our sixth year, we’re proud of our team of 300+ 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.