Associate Director Vector Analytical Development
Company: Atara Biotherapeutics, Inc.
Posted on: February 22, 2021
Associate Director, Vector Analytical Development The Associate
Director Vector Analytical Development will have overall
responsibility for leading and managing a dynamic team developing
advanced analytics supporting viral vector characterization and
release. The ideal candidate will assume a key leadership role in
the development of analytical strategies and will be expected to
implement on platform evaluation, deep characterization of viral
vectors (adenovirus, retrovirus), CQA assessments, etc. in
early-stage clinical manufacturing, product release testing, and
product characterization. The individual with work to build,
manage, and mentor a strong technical team to deliver key data,
documentation, and knowledge transfer. Primary
- Oversee the development, optimization, and
qualification/validation of robust molecular and cellular
- NGS, qPCR, ddPCR and other molecular assay platforms for the
characterization of cell and gene therapy drug products, vector,
and critical starting material
- Evaluation of nucleic acid characteristics like residual
impurity DNA, residual adeno- and retrovirus, etc.
- Cell-based functional assays for viral transduction/gene
- Provide expertise for enhancing existing assays, and
implementation of new ideas and technologies
- Provide leadership and guidance in designing and execution of
method qualifications per ICH and regulatory guidelines.
- Represent the analytical development team in cross-functional
CMC meetings, and actively participate in strategy design,
execution, data presentation and follow-up.
- Form active collaboration with other teams within Analytical
Development, Process development, Research and Quality teams.
- Collaborate with external partners, CMOs to lead or monitor
outsourcing activities, manage timelines, and ensure
- Author technical reports, protocols, and analytical sections of
regulatory filings. Qualifications Education, Experience and
- MS/Ph.D. in virology, molecular biology, or related sciences
such as cell biology, genetics, or immunology
- Minimum 8 years (Ph.D.) or 15 years (MS) of biopharma industry
experience with demonstrated track record of successfully
developing different molecular biology analytical methods using
techniques like next-generation sequencing (NGS) platforms, qPCR,
droplet digital PCR (ddPCR), flow cytometry
- Deep understanding in advanced analytical platforms and method
development/qualification/validation of CAGT methods including
cell-based assays, cytotox assays, flow cytometry and/or single
cell molecular assays
- Prior hands-on experience with qualifying and validating
assays; understanding of ICH/ FDA guidelines, and phase appropriate
GMP requirements is required.
- Prior experience of IND, BLA or equivalent regulatory filings
is highly preferred.
- Experiences with analytical or statistical software (e.g., JMP,
Softmax Pro, Gen5 etc.), is highly desirable.
- Experience of working with and managing external vendors/ CROs
- Experience working with automation of analytics is
- Strong writing, reviewing, and presentation skills is
- Must have strong organization skills, and experience of
mentoring Ph.D.-level scientists is required.
- Ability to multi-task in a fast-paced environment with changing
priorities. More About Atara Bio We launched--Atara
Biotherapeutics--in August 2012 to help patients with serious
diseases and few therapeutic options. We're named after Atara
Ciechanover who suffered from cancer before passing away. 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
400+ 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.
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." Visit www.atarabio.com 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. Thousand Oaks, California Associate
Director, Vector Analytical Development
Keywords: Atara Biotherapeutics, Inc., Denver , Associate Director Vector Analytical Development, Executive , Denver, Colorado
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