Atara Biotherapeutics, Inc.
Associate Director, Quality Control
Atara Biotherapeutics, Inc., Thousand Oaks, California, United States, 91362
The Associate Director of Quality Control oversees internal and external QC activities at Atara’s contract test labs (CTLs). Responsibilities include method development decisions, site-to-site transfers, and method qualification/validation. This role collaborates with Atara’s QC and Analytical Development experts to ensure strategic and tactical deliverables. Additionally, the Associate Director manages contracts, invoices, and supports QC analytical qualification and validation at CTLs.
Reports to:
Vice President, Quality Operations
Location:
Thousand Oaks, CA
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.
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Reports to:
Vice President, Quality Operations
Location:
Thousand Oaks, CA
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.
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