Seeking CMC Technical Manager for CMC Operations in Cell Therapy - (Manhattan, NYC) New York City

CMC Technical Manager/CMC Operations (Cell Therapy)

Atara Biotherapeutics' mission is to develop novel treatment options for patients with severe and life-threatening conditions that have been underserved by scientific innovation. We serve that mission by investigating biotech-derived therapies targeting unique pathways to halt or reverse patients' underlying diseases

Position Summary:
The purpose of this position is to support all manufacturing and supply chain activities for the development of the company's investigational cell therapy products. Provide project management support and coordinate analytical and stability program coordination with Memorial Sloan Kettering Cancer Center (MSKCC) in New York City, NY, and manage the supply chain of any company cell therapy products in support of clinical trials and potential commercialization.

Reports to: Vice President, Manufacturing & Technical Operations

Location: New York City (approximately first 18 months) and then company paid relocation to Westlake Village (Los Angeles area), CA
.
Major Duties / Responsibilities
• Provides day-to-day oversight of cell therapy product manufacturing at MSKCC including the activities MSKCC's technical transfer to CMO and cGMP process compliance improvement initiatives.
• Manages the schedules of all cell therapy manufacturing and QC testing and related data processing activities for all Atara cell therapy products, and ensures that all stability program time points follow the protocol schedule and are reported on time.
• Provides document tracking support for all documents supplied by MSKCC into the Atara Bio data repository system.
• Provides project management for all Atara Bio - MSKCC related activities. This includes preparing Gantt charts for tracking process/formulation/analytical development, manufacturing, testing, and reporting activities for all Drug Substance and Drug Product projects.
• Develops, executes, and manages all distribution and shipping studies to support CMC and clinical product transportation.
• Performs other related duties as assigned.

Skills & Abilities
• Strong communication skills (e.g., clear and concise), team player, proven negotiation skills.
• General understanding of pharmaceutical development, clinical research, cell therapy manufacturing, project management, and virtual CMO business model.
• Strong time and project management skills. Sound organizational skills.
• Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
• Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.
• Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
• Able to understand and interpret data/information and its practical application.
• Possesses a sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
• Motivates team members; fosters and nurtures teamwork.
• Role model for Atara Biotherapeutics values.

Education & Professional Experience

• Minimum of a Bachelor's degree, preferably in Chemistry/Life Sciences/Health Related Sciences, from an accredited college or university.
• 5-7 years of related cell therapy manufacturing and analytical testing laboratory industry experience, with at least 4 of those years directly in a CMC environment
• Excellent knowledge and experience of CMO activities
• Proficient in pertinent software & tools such as MS Project, Excel, Word, SharePoint, and Power Point.
• Must be knowledgeable and worked in cell therapy related industry.

Information about this role and other opportunities can be found at http://www.atarabio.com/careers/

Atara Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Atara Bio complies 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 U.S.


compensation: competitive market salary + stock option package

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