Manufacturing Associate (Subject Matter Expert) - Cell Culture / Upstream
- Research Triangle Park, NC
- Department: Manufacturing
- Region: US
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.
In Cell Culture specifically, we perform critical upstream processing activities within Current Good Manufacturing Practice (cGMP) biosafety cabinets, which include:
- 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
We are seeking true Subject Matter Experts in these areas above - those who are proficient enough to work independently in their area(s) but can also be called upon to lead in the execution of procedures and to mentor & train junior associates.
What You’ll Do:
- Perform and be a role model for execution of 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
- Perform and lead in conducting in-process sampling and sampling analysis (pH, Conductivity, 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 an energetic, detail-oriented professional that loves fast-paced, high visibility work that is incredibly impactful. Subject Matter Experts in this space know that producing clinical and commercial products in an environment like ours can be complex; so the flexibility to be adaptable is critical.
- Bachelor’s Degree (STEM preferred) + at least 2 years of direct and/or military experience OR
- BioWork Certificate or Associate’s Degree + at least 2.5 years of direct and/or military experience OR
- High School Diploma (or equivalent) plus at least 3 years of direct and/or military experience
- Foundation in targeted biopharmaceutical training strongly preferred
- Experience executing and troubleshooting Cell Culture equipment (bioreactors) and processes
- Ability to interpret and apply Good Manufacturing Practices (GMP) knowledge, including documentation
- Understanding of process automation and software systems (e.g. DeltaV, LIMS, etc.)
- Ability and desire to influence and encourage others
- Demonstrated experience employing learning agility
- Adaptable to changing needs and demands, comfortable navigating a dynamic environment
- Excellent communication skills (both verbal and written) throughout all levels of the organization
- 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)
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.