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Senior Manager, Manufacturing / Associate Director (Swing Shift) El Segundo United States,  

Job Score (company)


Posted on : 03 July 2017

Project Description

Description:
  • Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. 
  • The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. 
  • Our company is seeking a highly-motivated individual with cell culture and/or drug product manufacturing experience to oversee a team of supervisors and cell therapy manufacturing specialists in a clinical/commercial pharmaceutical environment.


Responsibilities (include but are not limited to):
  • Oversee the on-the-floor operations of our commercial cell therapy manufacturing facility in a cGMP environment 
  • Build a team, provide necessary training and ongoing coaching, discipline and recognition of direct staff, including performing annual performance reviews 
  • Generate SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacture 
  • Execute production and resource schedule against operational plan 
  • Ensure performance of all process steps specific to the phase or stage of operation (e.g. upstream, downstream, support) 
  • Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements 
  • Complete the final review of completed manufacturing documentation per compliance standards and established timelines 
  • Investigate and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management 
  • Interact with outside vendors and senior management 
  • Participate in multi-functional project teams, as necessary 
  • Take corrective action to bring about required changes using change control procedures 
  • Other duties as assigned 


Requirements:
  • Bachelor s degree in biology or related field with at least 12 years of experience managing a manufacturing team in the biotechnology or biologicsindustry (advanced degree preferred) 
  • Able to build and manage a team as well as train entry-level personnel 
  • Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's) 
  • Sufficient understanding of process, systems and equipment to troubleshoot problems and provide solutions to senior management 
  • Expert knowledge of electronic quality systems 
  • Must be able to work on off shift hours as well as part of the on-call rotation as needed is required; weekend shift likely 
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment 
  • High energy level and a positive outlook coupled with the requisite can do  attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles 
  • Willingness to think outside of the box and adapt best practices to our small, but growing environment 
  • Ability to adapt in a constantly evolving environment 
  • Self-motivated with a strong sense of ownership in areas of responsibility 
  • Previous cell culture and/or drug product experience preferred/highly desired 
 

Locations

El Segundo CA

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