Sr. Manager, Process Development

Company: Atara Biotherapeutics
Location: Thousand Oaks
Posted on: May 3, 2021

Job Description:

Job Description

This position will work within the Process Development team in Tech Ops to lead the characterization plan for cell therapy manufacturing processes and products. The Sr. Manager will lead the execution of CMC strategies within process development to enable and deliver on regulatory filings. The candidate will provide strategic, technical and scientific leadership to the team and support process transfer to manufacturing. The position will be based out in Thousand Oaks.

Reports to: Director of Cell Therapy Process Development

Location: Thousand Oaks (NW Los Angeles area), CA

Primary Responsibilities

• Serve as the Subject Matter Expert (SME) for T-cell Manufacturing unit operations and collaborate with Quality, Regulatory, Tech Service, Supply Chain and Manufacturing functions
• Author technical and regulatory documents, including drafting, reviewing, approving, and supporting regulatory filings for IND submission
• Author and/or review internal documentation (SOPs, protocols, reports, specifications, CQAs, risk assessments, etc.).
• Responsible for integrating scientific/technical efforts around cross-functional issues
• Collaborate with stakeholders to define user requirements for technology and critical raw/ancillary materials
• Provide input to study design for process characterization to generate data for use in regulatory filings.

Qualifications

Education and Experience

• PhD in a biological or engineering science with 4+ years of industry related experience, OR Master's Degree with 8+ years of related industry experience OR Bachelor's Degree with 10+ years of experience.
• Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes
• Proficient in ICH, FDA, EMA, and JP regulations and guidance
• Highly experienced with statistical methods for engineering and basic sciences
• Experienced in authoring CMC sections for filings
• Familiar with data package and reports required to advance processes into clinical manufacturing.
• Experienced with process characterization, and comparability studies.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

Preferred

• Knowledge and experience in mammalian cell culture / biotechnology related development (aseptic operations, cell biology, biochemistry upstream & downstream cell therapy manufacturing processes).
• Prior experience developing automated closed manufacturing technologies in cell therapy
• Familiarity with development and /or commercialization of cell-based therapeutics
• Basic understanding of cGMP requirements.
• Experience using SAS JMP software

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.

We're proud of our team of 400+ Atarians co-located by design in 4 different locations including South San Francisco (corporate headquarters), Thousand Oaks (R&D and manufacturing headquarters), Zug, Switzerland (european headquarters) and a R&D site in the Denver, Colorado area. 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. 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.

Keywords: Atara Biotherapeutics, Thousand Oaks , Sr. Manager, Process Development, Other , Thousand Oaks, California