Job Description
- Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system. Coordinates and/or leads process steps as required, serving as a process step(s) expert.
- Capable of leading shift when supervisor is absent, and actively leads or participates in shift exchanges. Coordinates activities and daily schedules with cross-functional areas.
- Executes or directs validation protocols without the need for supervision.
- Documents/records and reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Develops and/or revises documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks.
- Actively participates in training activities, managing their own individual training plan. Provides training to other associates as required and shares knowledge with others.
- Investigates deviations, develops and implements corrective and preventative actions as required by supervisor. Leads and/or actively participates in troubleshooting.
Qualifications
The desired candidate should be highly detailed oriented with excellent documentation skills and exceptional troubleshooting abilities. The incumbent is expected to be an expert on multiple unit operations, have excellent technical understanding of the processes and equipment, and is skilled at leading, scheduling tasks, training, and supporting other associates.
Additional Qualifications include:
- Bachelor’s Degree in an engineering or scientific discipline preferred plus 4+ years of direct experience
- High School Diploma (or equivalent) in addition to 5+ years of direct experience
- Possesses a thorough understanding of the manufacturing process, including manufacturing support activities
- Strong technical knowledge, including understanding relevant engineering and scientific concepts
- Possesses strong technical understanding of equipment function, application and procedures, and identifies potential process and equipment improvements
- Understands the theory and concepts behind the process, including an understanding of the impact of their own area on upstream and downstream activities
- Knowledgeable on routine and non-routine process occurrences
- Recognizes potential process and equipment problems
- Understands implications of test/process specifications, operating ranges, alert and action limits
- Able to apply understanding to avoid potential issues. Writes new SOPs and edits existing SOPs
- Understands basic biotechnology processing – purpose of major unit operations and microbial control concepts. Models the Biogen leadership values and behaviors
Additional Information
Performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents. Ensuring compliance to cGMP as well as maintaining equipment and facilities. The MA is highly detailed oriented with excellent documentation skills and exceptional troubleshooting abilities. The MFG lead is, expected to be an expert on multiple unit operations, have excellent technical understanding of the processes and equipment, and is skilled at leading, scheduling tasks, training, and supporting other associates. Works closely with shift Supervisor and coordinates critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position.