Lead, Manufacturing – Cell Culture (Day Shift)

Manufacturing          ·        Research Triangle Park, NC         ·         Full time 

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

Job Description

About This Role: 

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.
• 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 Large Scale Manufacturing (LSM) Cell Culture 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. We prioritize the possession of a few soft skills in addition to technical experience, with the opportunity for continued career development and on the job training. Key soft skills to look for are teamwork, interpersonal skills for conflict resolution, patience, and willingness to follow procedures. The ideal candidate will have Bioworks or biomanufacturing training, and degrees in microbiology, fermentation engineering, biotechnology, or biology. 

Qualifications

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 

Preferred Skills

• Prior cell culture and media prep experience working with 100L-13K L mixed tanks. 
• Experience with Trackwise, Delta V and LIMS in addition to cGMP experience.
• Excellent Written and Oral Communication skills
• Ability to work 12 hours shifts

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.

All of your information will be kept confidential according to EEO guidelines.

Please click here to apply.