Manufacturing Associate (Purification LSM)

  • Research Triangle Park, NC
  • Full-time
  • Department: Manufacturing
  • Region: US

Job Description

 The Manufacturing Associate LSM performs and documents daily manufacturing operations in a cGMP environment that involves the operation of process equipment, execution of validation protocols, creating/ revising cGMP documents, and other assignments. The incumbent is highly detailed oriented with excellent documentation skills. The incumbent will become trained and skilled at most or all unit operations in their area, often leading the execution of procedures, and performs most functions with minimal supervision.

  • Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record and control system. May coordinate or lead process steps as requested
  • Documents/Records and Reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Revises or creates documents as instructed. Key documentation includes batch records, SLRs, and equipment logbooks.
  • Actively participates in training activities, managing their individual training plan. Trains other associates as required.
  • Executes validation protocols with minimal supervision/direction of others.

Qualifications

  • High School diploma required
  • cGMP experience and prior BioPharma experience preferred
  • Targeted biopharmaceutical training (Bioworks or equivalent) and/or related military training also preferred.
  • Detailed oriented with excellent documentation skills
  • Operates in a safe manner in order to avoid injury to self and others
  • Strong peer and team leadership skills.
  • Adaptable to changing needs and demands, comfortable navigating in a changing environment
  • Comfortable with ambiguity; quickly understands the needs based on the situation at hand
  • Influencing and leading a positive attitude throughout team
  • Ability to communicate clearly and effectively to all levels of the organization
  • Ability to interact with others in a professional and courteous manner in accordance with Biogen’s Core Behaviors
  • Capable to work a 12-hour shift, both day shift or night shift

Additional Information

The Manufacturing Associate performs and documents daily manufacturing operations in a cGMP environment that involves the operation of process equipment, execution of validation protocols, creating/ revising cGMP documents, and other assignments.

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