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Manufacturing Manager

  1. East Coast
  1. Contract
Competitive
26807
  1. Life Sciences
Date Posted11 Jun 2021
Manufacturing Manager- Pennsylvania - Pharmaceutical

Our client is a leading and rapidly expanding Biologics company looking for a Manufacturing Manager to support them meet their customers’ needs and drive manufacturing process and teams.

The Role:

Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices.


Job Function:
  • Oversees and monitors overall performance of aseptic technique ensuring compliance with standards
  • Trains, coaches, mentors front line management and manages performance of others.
  • Understands, determines and manages maintenance requirements (preventative and calibration) of equipment and works with vendor to resolve issues
  • Drives sourcing and purchasing of standard, new and complex equipment
  • Reviews and approves solution and material preparation results and resolves issues
  • Possesses technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy
  • Possesses basic and fundamental engineering and mechanical knowledge and isable to apply in the manufacturing area demonstrating unit operational and end-to-end understanding
  • Has participated in facility start-ups and may lead a subteam that requires leading,planning, coordinate, delegate and manage across site specific programs
  • Reviews and approves protocols and other technical transfer documents
  • Identifies and drives application of GMP concepts and is able to recommend and
  • identify improvements as the process develops across the site during phases of technical transfer
  • Executes in-house and offsite validation activities
  • Identifies validation gaps and needs across site specific programs
  • Approves CS forms
  • Approves change controls for new material implementation
  • Possess awareness for all support systems (e.g. LIMS)
  • Acts a lead, member, Champion or Sponsor that helps to design the new system or of a systems improvement team
  • Identifies process and method gaps and opportunities and implements improvements across site
  • Collects, records, reviews, performs analysis, interprets, identifies trends of scientific and process data per good document practices
  • Communicates with internal and external stakeholders scientific and process data and recommends path for forward processing
  • Follows compliance and regulatory requirements and current Good Manufacturing
  • Practices (cGMPs) and understands ‘why’ behind the regulations.
  • Follows and executes Standard Operating Procedures (SOPs)
  • Reviews and approves SOPs
  • Improves the efficiency and right-first-time (RFT) of BR execution
  • Accountable for ensuring front line management ensure associates are trained on SOPs, equipment, all unit operations and non-manufacturing SOPs and systems
  • Identifies, participates, suggests solutions and leads complex technical problem solving
  • First line decision maker for technical problems
  • Accountable for schedule preparation, forecasting, adjustments and performance of work assignments for team to ensure adequate staffing across site specific programs and site
  • Regularly interacts with groups that support manufacturing
  • Coordinates, deals with problems and is the first line manufacturing decision maker with groups that support manufacturing in a cross functional manner
  • Has basic financial knowledge and acumen
  • Manages the manufacturing process, projects and people
  • Demonstrated Lean / Six Sigma knowledge desired
 
Qualifications and Skills:
  • HS Diploma or equivalent required and
  • 5+ years relevant technical experience and min 2 years Managing people
  • BS/BA in Science related field preferred; or combination of relevant Experience & Education
If this role is of interest to you, please apply today

 

 



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