Lead, Manufacturing – Night Shift
Biogen Posted on 2022-11-23
| Salary | Not mentioned |
|---|---|
| Location | Research Triangle Park, NC 27560 |
| Type | Full-time |
Job Description
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:
- Execute manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system. Coordinate and/or lead process steps as required, serving as a process step(s) expert.
- In coordination with Supervisor, schedule 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.
- Document/record and review cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Develop and/or revise documents as needed. Key documentation includes batch records, SLRs, and equipment logbooks. Ensure completeness of BPR/SLR real time review.
- Actively participate in training activities, managing their own individual training plan. Provide training to other associates as required and shares knowledge with others. Observe performance of employees, provide timely and targeted coaching for employees, and provide feedback to Supervisor mid and end of year.
- Initiate / investigate deviations, develop and implement corrective and preventative actions as required by supervisor. Lead and/or actively participate in troubleshooting. Serve 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 in an engineering or scientific discipline preferred + 4 years of direct biomanufacturing experience
- Associate degree in an engineering or scientific discipline preferred + 4.5 years of direct biomanufacturing experience
- Certificate or HS diploma in an engineering or scientific discipline preferred + 5 years of direct biomanufacturing experience
- You have experience running a team and are a strong technical SME on Purification related topics.
Preferred Skills
- Degree in an engineering or scientific discipline preferred
- Possesses downstream / purification experience
- Possesses strong technical understanding of equipment function, application, and procedures, and identifies potential process and equipment improvements.
Additional Information
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.
Company description:
confidential
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