Senior Manufacturing Technician

Role Summary

Senior Manufacturing Technician in Framingham, MA. Supports early and late-stage development of biological products within the Technical Pilot Plant Lab Operations group, focusing on media and buffer preparation. Operates manufacturing equipment and maintains documentation in a cGLP/cGMP environment.

Responsibilities

• This candidate will operate general manufacturing equipment in strict accordance with SOPs to complete tasks in support of the BioDev-CCD, BioDev-PD and BioDev-CMSC groups.
• Operate manufacturing equipment in strict accordance with SOPs to complete tasks in support of BioProcessing operations.
• Perform component weighing, batching of media and buffers, sterile filtration and aseptic techniques in a cGLP manufacturing facility.
• Routine production of media and buffers at 50L – 2000L scale.
• Perform CIP for formulation tanks. Perform the set-up of process equipment.
• Operate complex systems and equipment in strict accordance with SOP's, and safety guidelines.
• Maintains all associated documentation for operations being performed.
• Accurately complete batch records and logs sheets.
• Monitor and maintain laboratory equipment operation.
• Troubleshoot processing problems.
• Maintain good communications and collaboration with colleagues in other groups and departments.
• He/she will ensure that the highest standards of safety and environmental compliance are maintained in the workplace and operate under the regulatory requirements for biologics product development and manufacturing.
• All activities are closely supervised, and work is reviewed upon completion.

Qualifications

• Required: Associate’s Degree, preferably in the Scientific field, with 1-3 years direct relevant experience in a GLP/cGMP environment.
• Required: Biotechnology certificate and a minimum of 3 years biotech or pharmaceutical experience.
• Preferred: Familiar with cGMP/cGLP.
• Preferred: Ability to handle multiple tasks simultaneously; strong attention to detail; logical and critical thinking; innovative problem solving; ability to function in a matrix/team-oriented environment; self-motivation with excellent organization and communication; computer software skills (Excel, Word, PowerPoint).

Skills

• Process equipment operation
• Aseptic technique and sterile filtration
• Documentation and batch record accuracy
• Equipment setup and CIP
• Laboratory and process troubleshooting
• Communication and collaboration
• Software: Excel, Word, PowerPoint

Education

• Associate’s Degree in a scientific field
• Biotechnology certificate