Sr. Director, Analytical Development
Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: May 3, 2021
The Sr. Director, Analytical Development leads the analytical
development function and staff in support of product and platform
development for Atara allogeneic 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 Sr. 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 Sr. 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 Sr. 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
Reports to: VP, Process Sciences
Location: Thousand Oaks, CA
Travel: up to 25%
- Serves as the technical and strategic expert in method
development for strength, purity and potency attributes of T-cell
therapy products for purposes of product lot release and
characterization in association with a GMP manufacturing
- Establishes, communicates and manages project plans and
timelines for phase-appropriate method development, qualification,
transfer to QC and validation support.
- Responsible for execution of Phase 1 product release testing
per qualified methods within a phase-appropriate GMP-compliant
- Shapes approach and policies for developing and establishing
- 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, CQAs, 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
- 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
- Hires, supervises and mentors scientific staff.
- 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
- Fundamental knowledge in cell biology, immunology, cell
culture, cell-based assays and assays standard to cell therapy
- 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.
- Role model for Atara TRAIT values (Transparency, Respect,
Accountability, Integrity, Trust)
More about Atara Bio
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
Our vision - "T-Cell Immunotherapy for every patient, any
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, Thousand Oaks , Sr. Director, Analytical Development, Other , Thousand Oaks, California
Didn't find what you're looking for? Search again!