Manufacturing Operations Lead

4 weeks ago

Triangle Township, United States Biogen Full time
Job Summary

We are seeking a highly skilled and experienced Manufacturing Lead to join our Large Scale Manufacturing Cell Culture team at Biogen. As a key member of our team, you will be responsible for overseeing daily manufacturing operations in a cGMP environment, ensuring compliance to cGMP, and maintaining equipment and facilities.

Key Responsibilities
  • 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.
  • 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, ensuring completeness of BPR/SLR real-time review.
  • Actively participate in training activities, managing their own individual training plan, and providing training to other associates as required.
  • Initiate/investigate deviations, develop and implement 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 Purification experience in a leadership capacity.
  • Lean, Six Sigma, and 5S certifications.
  • Experience with Trackwise, Delta V, and LIMS in addition to cGMP experience.
  • Highly detailed-oriented with excellent documentation skills and exceptional troubleshooting abilities.
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. Above all, 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.

All qualified applicants will receive consideration for employment 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. Biogen is an E-Verify Employer in the United States.

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