Manufacturing Associate (Recent Grad/Entry Level) – Upstream & Downstream

Job Description

This requisition represents multiple open positions in our RTP Manufacturing organization.  The Talent Acquisition team continually assesses all applicants that apply through this posting and will reach out to the selected candidates to discuss current and future opportunities.

About This Role

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; with two main areas/disciplines – Upstream (Cell Culture) and Downstream (Purification). MAs perform these critical steps within Current Good Manufacturing Practice (cGMP) biosafety cabinets and cleanroom suites. Some of the activities include:

Upstream / Cell Culture

• 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
  • Dispensing raw materials batching of media & solutions

Downstream / Purification

• Buffer Preparation
• Column Chromatography
• Viral Filtration
• Ultra-Filtration
• Bulk Dispensing of the drug substance

 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
• Assist in conducting in-process sampling and sampling analysis (pH, Conductivity, Protein Concentration, Osmolarity, Cell Counts, etc.)
• 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
• 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.

Qualifications

• Bachelor’s Degree (STEM preferred) OR
• BioWork Certificate or Associate’s Degree OR
• Military training & experience and are soon to transition OR
• High School Diploma (or equivalent) plus at least 6 months of related experience

• Foundation in targeted biopharmaceutical training is preferred, but not required
• 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
• Ability to lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds
• Capable of working twelve (12) hour shifts (we operate both day and night 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.