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Lead, Manufacturing
3 months ago
This position will work 12-hour NIGHT SHIFTS (approx. 6:00pm - 6:00am) on a 2-2-3 rotation
About This Role
Manufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations – each person playing a critical role in delivering our therapies to the patients who need them. This position will be in our Parenteral Filling operations, and our teams operate across the following units:
- Component Preparation
- Compounding
- Parenteral Filling/Lyophilization
- Visual Inspection
What You’ll Do
- Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating Procedures (SOPs)
- Document and record all cGMP data & information (including deviations) for processing steps and equipment activities. Create and revise key documentation like batch records, SLRs, and equipment logbooks
- Help maintain a clean and safe work environment, always focusing on audit readiness of process areas
- Be a team player and leader; always showing up to contribute your energy and focus
- Assist in investigations of procedural deviations
- Adhere to aseptic gowning and operating procedures
- Actively participate and lead in training and development initiatives, both for personal growth and for that of your team members
Who You Are
You are someone developing a deep passion for doing work that furthers a mission to save lives. You have a high degree of demonstrated learning agility, are energetic, and love a fast-paced work environment where everything you do is incredibly impactful. Biomanufacturing is complex, so you have the mental flexibility to be adaptable to whatever comes your way.
QualificationsRequired:
- Bachelor’s Degree (STEM preferred) + at least 4 years of experience OR
- BioWork Certificate or Associate’s Degree + at least 4.5 years of experience OR
- High School Diploma (or equivalent) plus at least 5 years of experience
- Capable of working twelve (12) hour shifts in a predetermined schedule rotation
- Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds
- Strong desire to learn and grow quickly - demonstrated experience employing learning agility
- Adaptable to changing needs and demands, comfortable navigating a dynamic environment
- Strong communication skills (both verbal and written) and ability to work as a part of a team
Additional Information
Why 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. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, 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. Read on to learn more about our DE&I efforts.
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.
