Manufacturing Associate II- Affinity Resin Manufacturing

This position is for the 1 st shift in the Affinity Resin Manufacturing group, however; cross training into other departments may be required.

The successful candidate will play a key role in ensuring that the department’s production and quality goals are met. 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/document controlled environment would be beneficial. 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 and also to work overtime.

• Contributes to the daily operation of the Repligen Affinity team, which will include the following:
  • Large scale buffer preparation
  • pH precipitation
  • Sterile filtration
  • Equipment cleaning (CIP)
  • Timely and accurate completion/review of production documentation
  • Entry of in-process data into trending databases
  • May be required to cross train into other departments.
• Maintain a safe working environment and follow all site safety procedures.
• Ensures all manufacturing processes are carried out according to approved batch records and SOPs
• Reviews batch records for accuracy and in a timely manner. Reports deviations to Quality Assurance Participates in development and implementation of Corrective Actions

• BS degree in biological sciences, or a related field preferred, or a minimum of two years experience in biotech manufacturing.
• Excellent organizational and communications skills
• Must be resourceful and self-motivated
• Must be willing to work overtime (including evenings and weekends) as required.
• Must be able to lift 25 lbs unassisted.