Sr. Manager, QC - Stability (REMOTE)

Job Description

The Sr. Manager, QC - Stability supports and helps lead the development, execution, and evolution of Atara’s Global Stability program, which includes, but is not limited to, short and long-term stability studies for GMP cell banks, starting materials, critical reagents, reference standards, and final drug products. Scope covers both clinical and commercial materials. Responsible for direct interaction with Process Sciences, Manufacturing, Product Quality, Regulatory Affairs, Quality Assurance, and Quality Control. The Senior Manager is responsible for ensuring development and/or revision of the Stability Master Plan, Stability Program SOP, Stability Protocols/Reports, and timely stability data requests.

Location: Thousand Oaks, CA

Reports to: Associate Director, Quality Control

Travel: Up to 10%

Primary Responsibilities:

Design and manage stability test protocols for Atara clinical product lines from early development until commercialization following ICH guidelines.

Manage and oversee stability tasks for contract labs, contract manufacturing labs and in-house Sample Management and QC labs.

Coordinate with QC management to ensure stability samples are scheduled/tested at each timepoint within pull/test tolerance.

Perform stability trending and reporting for all Atara product lines.

Create stability master plan for Atara clinical product lines.

Create and maintain stability SOPs.

Work with functional teams including Product Sciences, Quality Control, Contract Manufacturing Organizations, Regulatory and Product Quality to determine stability study design and timeline to support Atara products for Regulatory filling.

Responsible for drafting stability data, summary and post approval sections for Regulatory submissions and updates.

Responsible for the continuous development of Atara’s Stability Program.

Support stability projects for clinical products for Atara.

Technical lead for deviations and change controls related to stability in Veeva.

Represent Atara stability topics in quality and regulatory audits.

Continuously review applicable guidance on worldwide regulatory changes applicable to stability.

Uses judgment and creativity and sound technical knowledge to obtain and recommend solutions. May interface with senior management to convey information.

Understands company goals and practices and applies them when resolving a variety of problems. Receives only general instructions on new work.

Work is project-oriented and actual tasks must be defined by employee.

Identifies and maintains required GMP validation and change control documentation.

Qualifications

Bachelor’s Degree in Biochemistry, Molecular and Cellular Biology, Immunology, or Biology.

8+ years of QC experience in the pharmaceutical industry supporting cGMP areas.

Experience in cGMP cell therapy manufacturing and/or testing facility.

Advanced knowledge of Stability.

Strong independent judgment and decision-making abilities.

Advanced knowledge of relevant regulations and guidance required in order to act as a resource for colleagues.

Independent decision-making capability and ability to think conceptually and understand impact of decisions critical.

Strong conflict resolution and negotiation skills.

Proven project management skills required. Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.

Excellent verbal and written communication skills, good interpersonal skills.

Flexibility to travel as required to accommodate the business needs.

Direct experience in GMP data handling in accordance with ICH, USP and FDA guidelines.

Direct experience in authoring GMP test protocols and reports, GMP SOPs, and GMP quality systems documents.

Direct experience analyzing data in Excel, JMP, and/or MiniTab.