The incumbent is highly detail-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 in the downstream unit operations. Downstream manufacturing work includes interactions with buffer preparation, column chromatography, viral filtration, ultra-filtration and bulk dispensing of bulk drug substance. Associates must be flexible and demonstrate learning agility to perform a variety of complex tasks to produce both clinical and commercial products in a fast-paced environment. We care deeply, and this drives us to working fearlessly to change all lives.

• 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.

• High School Diploma (or equivalent) and 1.5 years GMP direct/ 3 years related experience

OR

• Biowork Certificate in addition to 1.5 years GMP direct experience/ 3 years related experience OR
• Associate’s Degree (STEM Preferred) with 1 year of direct experience/ 2.5 years of related experience OR
• Bachelor’s Degree with 0.5 year of direct experience/ 2 years related experience
• Capable to work a 12-hour shift, both day shift or night shift
• Detailed oriented with excellent documentation skills
• Operates in a safe manner to avoid injury to self and others following all Log Out Tag Out (LOTO) and Site Safety procedures
• Strong peer and team leadership skills
• Adaptable to changing needs and demands, comfortable navigating in a changing environment
• Influencing and leading a positive attitude throughout team
• Ability to communicate clearly and effectively to all levels of the organization
• Ability to work with IT systems (e.g. DeltaV, LIMS, etc.)
• Ability to interact with others in a professional and courteous manner in accordance with Biogen’s Core Behaviors
• Operates in a safe manner to avoid injury to self and others following all Log Out Tag Out (LOTO) and Site Safety procedures

The Manufacturing Associate performs and documents daily manufacturing operations in a cGMP environment that involves operation of process equipment, execution of validation protocols, creating/ revising cGMP documents and other assignments. Biogen is hiring MA III, & IV level candidates.