Associate Director, Quality Control

Job Description:

Additionally, the Associate Director manages contracts, invoices, and supports QC analytical qualification and validation at CTLs.

Travel: Up to 25%

Primary Responsibilities:

• Manages Atara’s internal and external QC activities for CMO facilities and contract test labs (CTLs) used for raw material, in-process, stability, investigational, and product release testing.
• Supports method development discussions and decisions (including compendial vs. non-compendial) at the CTLs.
• Oversees site-to-site method transfers.
• Plans and supports method qualification/validation activities at the CTLs.
• Reviews and approves method validation protocols and reports.
• Develops and approves CTL scope-of-work, contracts, agreements, purchase requisitions/orders, and invoices.
• Supports QC relationship management between Atara and CTLs.
• Coordinates necessary sample/material shipments to the CTLs.
• Evaluates and supports CTL network optimization relative to Atara’s in-house QC capabilities.
• Assists in laboratory investigations, OOSs, root cause analysis, and corrective/preventive actions.
• Supports authoring and reviewing of Regulatory File sections.
• Ensures Supplier Quality for CTLs through quality agreement review, audits, and periodic monitoring.
• Provides internal and external (Regulatory audit) support for QC-related topics.

Qualifications:

• Bachelor’s Degree in Biochemistry, Molecular and Cellular Biology, Immunology, or Biology with 10+ years of experience or an equivalent combination of education and experience.
• 5+ years of experience supervising/managing direct reports.
• Prior experience managing internal and/or external CTLs.
• Quality Control and/or Analytical Development experience in the pharmaceutical industry.
• Cell and Gene Therapy or Biologics experience.
• Prior experience managing internal QC and/or external CTLs.
• Experience in Quality Control and/or Analytical Development.
• Familiarity with analytical method transfer, qualification, and validation.
• Strong communication skills, negotiation abilities, and teamwork.
• Ability to lead, motivate staff, and manage projects.
• Independent judgment and decision-making skills.
• Self-motivated, flexible, and creative in a fast-paced environment.
• Knowledge of relevant regulations and FDA/EMA guidance.
• Excellent verbal and written communication skills.

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.

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.