The Manufacturing Associate IV 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. You are skilled in end-to-end Parenteral Manufacturing and are a Subject Matter Expert (SME) expert in at least one unit operation (Compounding, Parenteral Filling, Component Prep or Visual Inspection). You will often lead others in the execution of manufacturing processes.

What You’ll Do:

• Execute manufacturing processing steps and/or manufacturing support activities according to cGMP requirements while monitoring the process against the batch record, SLR and control system
• Coordinates and/or leads process steps as required including adherence to good documentation practices
• Documents/records and reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures
• Revises and/or creates documents as instructed. Key documentation includes batch records, SLRs, and equipment logbooks.
• Investigates deviations, develops and implements corrective and preventative actions as required by supervisor
• Actively participates in training activities, managing their individual training plan and trains other associates as required

Who You Are:

If you are a highly detailed and focused individual that enjoys problem solving and teamwork, you are a great fit for our manufacturing team! This position will provide you the opportunity to collaborate and innovate with a group of individuals who are all passionate about transforming patient lives.

Required Skills:

Manufacturing Associate IV:

• High School Diploma (or equivalent) in addition to 3 years of direct experience OR
• BioWork Certificate or Associate’s Degree in addition to 2.5 years of direct experience OR
• Bachelor’s Degree with 2 years of direct experience

Preferred Skills:

• Targeted biopharmaceutical training and experience in Compounding, Parenteral Filling, Component Prep and Visual Inspection
• Detailed oriented with excellent documentation skills in a cGMP environment
• Ability to work independently and with minimal direction
• Aseptic certified
• Isolator Filling Experience

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. At Biogen, we work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.