Sr. Manager, External Manufacturing (Remote)

This Role

This role supports tactical operational activities associated with contract manufacturing organizations (CMOs) and manufacturing partners developing, producing and/or testing Atara products, key raw materials, and intermediates.

• Leads and supports on-the-floor manufacturing activities, manufacturing and validation readiness activities, championing of deviation investigations, corrective/preventative action implementation, and change control management, as well as support for regulatory inspections.
• Fosters cross-functional working relationships with internal and external groups, lead interactions between Atara Process Sciences, Quality Assurance, Supply Chain and Project Leadership and external manufacturing entities to ensure successful development and delivery of all products.
• Proactively provides strong scientific leadership and hands-on support and troubleshooting for all aspects of technology transfer, process scale-up, process monitoring, manufacturing, QC testing, packaging and logistics activities.
• Serves as a primary point of contact for all activities occurring at CMO including, manufacturing, planning, supply chain, quality, testing, regulatory, inspections, projects, and business relationship with the CMO.
• Provides support for regulatory submissions related to products manufactured at the CMO manufacturing sites for which this role has accountability.

Location: Thousand Oaks, CA (Flex schedule) OR Remote

Reports to: Sr. Director, External Manufacturing

Travel: Domestic and international travel will be required (up to 75%)

Primary Responsibilities

• Partners with CMO to ensure successful manufacture of products required for clinical supply, process validation and/or commercial supply.
• Identifies and drives process optimization initiatives and addresses opportunities for efficiency and capacity improvements.
• Leads and supports operations (technical, quality, supply chain, manufacturing, QC, packaging and logistics) activities associated with the manufacture of products at CMOs and partners.
• Collaborates with manufacturing quality partner and internal Atara quality teams to develop processes and systems that enable compliant, successful technology transfers, operation and lifecycle management of cGMP clinical and commercial manufacturing processes, ensuring all product delivery schedules are met.
• Owns and drives change controls to make necessary changes to cGMP processes.
• Tracks and maintains budget related to activities at the CMO and is responsible for ensuring activities complete per project timelines.
• Partners with Process Sciences and Quality teams to identify and drive process optimization initiatives and address opportunities for efficiency and capacity improvements.
• Supports guidance for process validation activities at the contract manufacturing facility. Provides technical input to Process Sciences for defining the critical parameters of new and existing processes.
• Provides technical depth to support troubleshooting efforts and leads high-level deviation investigations.
• Drives timely decisions and facilitates active communication and information flow between contract manufacturer and Atara team members.
• Authors technical documents for regulatory agency submission in support of manufacturing processes and serves as process subject matter expert in health authority interactions.
• Acts as Person-in-Plant (PiP) to oversee all aspects of operations at CMOs and works with CMO to implement improvements and necessary corrections to ensure compliant cGMP operations in line with any regulatory filings and product specifications

Qualifications

• Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive decisions among individuals from a variety of cultures and disciplines.
• Fundamental knowledge in cell biology, cell culture, cell processing and cell cryopreservation principles.
• Bachelors in a biological science with 6+ years of experience or Master’s and 4+ years of experience in biologics development including cell therapy development.
• Expert problem-solver that leads with data, seeks subject matter expertise and is considerate of others point-of-view.
• Demonstrated track record of effective leadership and partnership in a contract manufacturing setting.
• Demonstrated in-depth skills in contract negotiation, budgeting and project management.
• Effective interpersonal skills as both a team leader and a team player.
• Clear and concise communicator who is a team player and a proven negotiator.
• Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust).
• Strong leadership presence with ability to garner respect through sound technical analysis, business judgment and clear decision-making.
• Breadth of knowledge across cell culture technologies, cell processing technologies, cell characterization methods, manufacturing under cGMP, validation, Quality Systems and regulatory requirements.
• Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment.
• Demonstrated experience supporting technology transfers, cGMP manufacturing operations and CMC regulatory submissions and inspections required.

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.