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Title: Manufacturing Supervisor

Hiring Organization: Connexion Systems & Engineering

• Duration: Perm           
• Pay rate: $ 75K - 105K
• Job Location: Belmont, MA
• Job# 14655

Manufacturing Supervisor

candidate will be responsible for the team’s production and quality goals. Applicants must have strong technical knowledge and problem-solving skills. Must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner. Experience working in a GMP/ISO/document-controlled environment would be beneficial. Leadership skills, attention to detail, and the ability to work in a team environment are essential. Candidates must be willing and able to learn new manufacturing processes as the company grows.

Responsibilities

• Contributes to the daily operation of the Affinity team, which will include the following:
  • Fermentation using a 3000L bioreactor
  • Product recovery using Microfiltration and Ultrafiltration
  • Aseptic strain handling and liquid fill/finish within a Bio-safety cabinet
  • Product recovery using tangential flow filtration
  • Large scale buffer/media preparation
  • pH precipitation
  • Sterile filtration
  • Aseptic liquid fill/finish
  • Equipment cleaning (CIP/SIP)
  • Timely and accurate completion/review of production documentation
  • Entry of in-process data into trending databases
  • May be required to cross train into Purification
• Maintain a safe working environment and follow all site safety procedures.
• Supervise direct reports which includes setting objectives
• Monitoring performance and promoting development plans.
• Train operators on  production processes and Quality Management Systems
• Ensures all manufacturing processes are carried out according to approved batch records and SOPs
• Writes, revises and maintains SOPs, batch records and validation documents in accordance with policies
• Communicates with Quality Assurance and Materials Management to ensure raw materials are in place and released to prevent manufacturing interruptions
• May participate in project teams to develop, transfer, and scale up new manufacturing processes
• Support PM schedules, and coordinates with internal and external resources to ensure all equipment is calibrated and maintained as required
• Identifies process improvement opportunities and communicates such opportunities to management
• Reviews batch records for accuracy and in a timely manner. Reports deviations to Quality Assurance Participates in development and implementation of Corrective Actions

Qualifications

• Requires a BS in biology, chemistry or a related discipline with at least 4 years’ experience in the Biotech industry
• Demonstrated leadership skills, and ability to work in a team environment
• Excellent problem-solving skills
• Demonstrated experience and skill with process equipment, including plate washers and robotic dispensing systems
• Direct experience in validation of equipment and manufacturing processes
• Direct experience working within ISO9001 and/or GMP documentation and quality systems
• Experience in aseptic techniques and working in a laboratory setting
• Willing to work overtime as required
• Able to lift 25 lbs.
• Skilled in using ERP systems, Microsoft Excel, Word, Power Point, Outlook
• Excellent verbal and written communication
• Experience in LEAN manufacturing and 6 sigma a plus

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