Manufacturing Supervisor (Biomanufacturing) 2nd Shift (PERM)
Belmont, MA 02453 US
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.
Title: Manufacturing Supervisor
Hiring Organization: Connexion Systems & Engineering
- Duration: Perm
- Pay rate: $ 75K - 105K
- Job Location: Belmont, MA
- Job# 14655
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.
- 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
- 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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