Sr. Specialist Manufacturing

Job Locations US-CA-Thousand Oaks
ID
2021-1732
Category
Manufacturing
Type
Regular Full-Time

Job Description

Position Summary

The Senior Specialist, Manufacturing Plant Operations, is a critical leadership position responsible for supporting all operational aspects of Manufacturing. The Senior Specialist works as part of the Manufacturing team delivering on team goals to generate high quality materials used both in the clinical and commercial settings. The Senior Specialist serves as the Manufacturing Owner of activities across Technical Operations and within Atara’s Internal Manufacturing organization and Quality Management System, including:  New Product Introduction, inspection readiness, risk management, and other continuous improvement initiatives.

 

Reports to: Director, Manufacturing Plant Operations

 

Location: Thousand Oaks (northwest Los Angeles), CA

 

Primary Responsibilities

  • Manufacturing lead responsible for ensuring successful implementation of New Product Introduction
  • Lead complex, cross-functional, and high visibility sub-teams to advance Manufacturing goals
  • Provide leadership and direction on manufacturing-related continuous improvement and Operational Excellence projects
  • Lead and support Manufacturing network development for processes and systems
  • Partner with Manufacturing, Supply Chain, and Quality teams to identify and drive process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing
  • Provide input on suitability of technologies, scalability, and manufacturability to Process Sciences during process development activities
  • Support the implementation of metric and KPI reporting tools as part of Manufacturing’s Integrated Management System
  • Provide significant technical depth to support troubleshooting efforts and lead high-impact deviation investigations
  • Contribute to a culture that embraces the safety of the work environment and the safety of patients by complying with company procedures and policies and cGMP biologics cell culture manufacturing requirements
  • Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients
  • Work with internal regulatory and quality teams to ensure that all quality and regulatory standards and requirements are implemented and maintained
  • Drive timely decisions and facilitate active cross-functional technical communication and information flow between team members
  • Ensure effective risk management processes are implemented to prevent unanticipated failure modes and ensure capability
  • Work cooperatively with Atara leaders to implement programs to improve overall quality, improve operational efficiency, enhance organizational capability, and assure regulatory compliance
  • Champion the team mission, vision, and values

 

Travel: Travel required (up to 10%)

Qualifications

Physical Demands:

Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, manufacturing plant, or clinical environment.

 

Position Requirements:

  • Excellent analytical, interpersonal, communication, and technical writing skills
  • Good decision making and demonstration of delegating of authority
  • Strong organizational and project management skills
  • Proficient in using Microsoft applications (Word, Excel, PowerPoint, Project). 
  • Strong critical and logical thinking skills 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
  • Knowledgeable of CFRs and GMPs
  • Experienced at process, system, and equipment troubleshooting
  • Previous cell culture and/or drug product experience is preferred
  • Successfully worked in an environment with high quantitative performance measurements
  • Strong demonstrated leadership by guiding teams and delegating authority
  • Mindset for continuous improvement, innovation, and problem solving in an evolving environment
  • Must have a strong sense of ownership and a commitment to deliver quality in all aspects of the role
  • Role model for Atara’s values

 

Education & Professional Experience:

  • Bachelor or Science degree in biology, manufacturing, engineering, or related scientific field
  • 5+ years of experience within Technical Operations functions (e.g. Supply Chain, Manufacturing, Quality) working for a pharmaceutical, biotechnology, or biologics company

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