Manufacturing Operations Lead

4 weeks ago

Triangle Township, United States Biogen Full time
Job Description

This position follows a traditional 2-2-3 format from 6am-6pm on Black Day Shift, ensuring seamless execution of daily manufacturing operations in a cGMP environment.

The Manufacturing Lead performs and documents various tasks, including operation of process equipment, execution of validation protocols, and ensuring compliance to cGMP. This role works closely with shift Supervisors to coordinate critical activities collaboratively and utilizes resources efficiently.

The Manufacturing Lead responsibilities include:

  • Executing manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR, and control system.
  • Scheduling tasks for a given shift and planning resource allocation, including production, validation, or other project activities.
  • Documenting/records and reviewing cGMP data and information, following standard operating procedures.
  • Actively participating in training activities, managing their own individual training plan, and providing training to other associates as required.
  • Initiating/investigating deviations, developing and implementing corrective and preventative actions as required by Supervisor.

Requirements:

  • 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 Buffer Prep experience in a leadership capacity.
  • Lean, Six Sigma, and 5S certifications.
  • Experience with Trackwise, Delta V, and LIMS in addition to cGMP experience.

About Biogen:

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. We work together to deliver life-changing medicines, with every role playing a vital part in our mission.

We are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

We are an E-Verify Employer in the United States and are committed to equal employment opportunity without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state, or local law.

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