Manufacturing Associate II / III, Cell Culture (Nights)
Biogen
Summary
Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotation. This role follows a 2-2-3 calendar rotation on nights (6:00 PM – 6:00 AM ET), Black Nights rotating schedule.
Job description
Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; including – Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). This role’s primary focus is on Upstream Cell Culture operations: Mammalian cell culture & harvest: Work in Shake flasks, WAVE bags, centrifuges, stainless steel bioreactors up to 15,000L. Performing thaws and splits utilizing Aseptic technique.
What You’ll Do
- Perform inoculation thaws, splits, and pools using aseptic technique with WAVE bags and ITV cans
- Prepare bioreactors by executing automated CIP/SIP recipes using DeltaV
- Standardize and calibrate pH and DO probes during bioreactor preparation
- Perform inoculation of bioreactors across multiple scales
- Support cell growth operations, including media feeds and process additions
- Conduct routine sampling and in-process testing to monitor product quality
- Standardize and maintain laboratory and manufacturing equipment, including: Vi-Cell Blu/XR, Osmometer, pH meters, RapidPoint BGA, Conductivity meters, Biosafety cabinets, Small-scale centrifuges
- Accurately document activities in accordance with cGMP and SOP requirements
- Maintain a clean, safe, and compliant manufacturing environment
- Collaborate cross-functionally with Manufacturing, MSAT, Quality, and Engineering teams
Who You Are
You’re driven by a mission to save lives and bring a deep sense of purpose to the work you do. Biomanufacturing is complex, and you thrive in fast-paced environments where learning agility, problem-solving, and adaptability are essential.
Required Skills for a Manufacturing Associate II
The following combination of academic and/or relevant experience may be considered: Bachelor’s degree from an accredited college or university, STEM preferred and 0+ years of direct experience; A BioWorks Certificate or associate's degree, STEM preferred and 0+ years of direct experience; A High School Diploma (or equivalent) and at minimum of .5 years of direct experience. Previous experience in a GxP environment. Ability to follow SOPs and work effectively on shift schedules if required. Demonstrated documentation and data integrity skills. Understanding of aseptic technique and cleanroom practices is preferred.
Required Skills for a Manufacturing Associate III
The following combination of academic and/or relevant experience may be considered: Bachelor’s degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experience; A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience; A High School Diploma (or equivalent) and at minimum of 1.5 years of direct experience. Previous experience in a cGMP environment. Ability to follow SOPs and work effectively on shift schedules if required. Demonstrated documentation and data integrity skills. Knowledge of aseptic technique and cleanroom practices. Exposure to Delta V, Syncade, or similar systems. Experience performing bioreactor preparation, inoculation, and monitoring is preferred. Hands-on experience with mammalian cell culture operations is preferred.
Preferred Skills
- Bachelor’s degree in Science, Technology, Engineering and Mathematics (STEM) from an accredited college or university
- Strong communication skills and a team-oriented mindset
Requirements
- Bachelor’s degree from an accredited college or university, STEM preferred and 0+ years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred and 0+ years of direct experience
- A High School Diploma (or equivalent) and at minimum of .5 years of direct experience
- Previous experience in a GxP environment
- Ability to follow SOPs and work effectively on shift schedules if required
- Demonstrated documentation and data integrity skills
- Understanding of aseptic technique and cleanroom practices is preferred
- Bachelor’s degree from an accredited college or university, STEM preferred and at minimum .5 years of direct experience
- A BioWorks Certificate or associate's degree, STEM preferred and at minimum 1 year of direct experience
- A High School Diploma (or equivalent) and at minimum of 1.5 years of direct experience
- Previous experience in a cGMP environment
- Knowledge of aseptic technique and cleanroom practices
- Exposure to Delta V, Syncade, or similar systems
- Experience performing bioreactor preparation, inoculation, and monitoring is preferred
- Hands-on experience with mammalian cell culture operations is preferred
- Bachelor’s degree in Science, Technology, Engineering and Mathematics (STEM) from an accredited college or university
- Strong communication skills and a team-oriented mindset
Benefits
- Medical, Dental & Vision
- Life Insurance
- Fitness & Wellness Programs
- Short- and Long-Term Disability
- Paid Vacation
- Paid Holidays
- Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.