Manufacturing Associate (Experienced) - Biologics

This requisition represents multiple open positions in our manufacturing organization.  The Talent Acquisition team continually assesses all applicants that apply through this posting and will reach out to prospective candidates to discuss current and future opportunities.Our factories run 24/7 operations. Our manufacturing teams work 12-hour shifts (either Days or Nights) on a 2-2-3 calendar rotationAbout This RoleOur 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 15,000LPerforming thaws and splits utilizing Aseptic techniqueDispensing raw materials + batching of media & solutionsDownstream / Purification:Buffer PreparationColumn ChromatographyViral FiltrationUltra-FiltrationBulk Dispensing of the drug substance What You’ll DoExecute 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 logbooksAssist 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 areasBe a team player and leader; always showing up to contribute your energy and focusActively participate and lead in training and development initiatives, both for personal growth and for that of your team membersWho You AreYou 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.