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Manufacturing Supervisor - United States  

Company managed [?] Still accepting applications

Posted on : 01 June 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. 
  • We are seeking a highly effective Manufacturing Supervisor to be responsible for supervising a team of cell culture manufacturing specialists in a commercial pharmaceutical environment.  In this role you will report to the Manager of Manufacturing. 

 

Responsibilities (include but are not limited to):
  • Supervise 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 
  • Process monitoring, including manipulation of databases, documents and/or spreadsheets to support business reporting requirements 
  • 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 (or equivalent experience required), 2 years of experience supervising staff 
  • Able to build and lead 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 
  • Sufficient 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 experience preferred/highly desired 
 


About Us:
  • Our company is an equal opportunity employer.
  • We are able to offer the opportunity to be part this successful, fast growing company.  A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.