About This Role

This position is night shift (6pm-6am) that follows the 2-2-3 format schedule

The Manufacturing Lead 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. This position works closely with shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position.

The Manufacturing Lead responsibilities include but are not limited to:

• 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.
• Oracle inventory management.
• In coordination with Supervisor, schedules tasks for a given shift and plan resource allocation. This includes production, validation or other project activities. Also, responsible for proper information sharing at shift exchange and ensure all issues are communicated appropriately.
• 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. Ensure completeness of BPR/SLR real time review.
• Actively participates in training activities, managing their own individual training plan. Provides training to other associates as required and shares knowledge with others. Observes performance of employees, provides timely and targeted coaching for employees, and provides feedback to Supervisor mid and end of year.
• Initiates / investigates deviations, develops and implements corrective and preventative actions as required by supervisor. Leads and/or actively participates in troubleshooting. Serves as possible SME for audits.

Who You Are

Our Small-Scale Manufacturing (SSM) Purification team is looking for a self-starter who takes accountability, is willing to learn quickly in a dynamic environment, and prioritizes accurate and ethical data recordkeeping. In Purification, we perform critical downstream processing activities within Current Good Manufacturing Practice (cGMP) cleanroom suites at our Research Triangle Park (RTP) facility. These processes include Buffer Preparation, Column Chromatography, Viral Filtration, Ultra Filtration and Bulk Dispensing of the drug substance. Our Manufacturing 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. This position provides value to our organization by ensuring precise manufacturing of our life-changing therapies. This includes manufacturing therapies for multiple sclerosis, Alzheimer's disease and more. This manufacturing role supports the overall supply chain that delivers our therapies to the patients that need them. Our supply chain was recently listed by Gartner as a ‘Top 25 Supply Chain.’

Required Skills :

• Bachelor’s Degree + 4 years of direct biomanufacturing experience
• Associate’s Degree + 5 years of direct biomanufacturing experience
• Certificate or HS diploma + 6 years of direct biomanufacturing experience

Preferred Skills:

• Degree in an engineering or scientific discipline preferred
• Possesses downstream experience
• Possesses strong technical understanding of equipment function, application, and procedures, and identifies potential process and equipment improvements.

Why Biogen?

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. 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.