Assoc.PrincipleScientist,Process Dvlpmt

JOB REQUIREMENTS: Initiate, direct, & execute scientific research for innovation & process improvements in protein purification & clinical manufacturing, incl. investigating new chromatography resin & solution buffer systems, on-boarding new automated chromatography & filtration instruments, validating novel protein purification methods, introducing & evaluating novel affinity/anion exchange/cation exchange/hydrophobic interaction/mix matrix resins.Execute purification experiments incl automated chromatography using AKTAready, AKTAavant & AKTAprocess, normal filtration w/ peristaltic pump, clarification harvest using 3M depth filter & Millipore Pod filter, column packing in lab scale & in pilot scale, & tangential flow filtration on table-top scale & w/ automatic machine independently.Perform protein purification & analysis of pf all modes of chromatography, incl affinity chromatography, anion exchange chromatography, cation exchange chromatography, hydrophobic interaction chromatography & ceramic hydroxyapatite chromatography.Research, develop & characterize existing & new technologies/process in clinical manufacturing downstream process, incl performing biomanufacturing downstream process Failure Mode & Effects Analysis (FMEA), characterizing process solutions, investigating product & solution stability, validating process scale-down model for biomanufacturing, performing process limit evaluation, performing one-factor-at-a-time (OFAT) to evaluate process key factors, performing filter sizing & re-filtration evaluation, performing viral clearance evaluation, evaluating resin lifetime on protein purification chromatography process, & performing impurity challenge on current protein purification chromatography process.Write complex procedural standard operating procedures (SOP), batch production records, & reports.Act as the technical lead for client development projects, communicate project status internally & externally, & provide technical explanation/rationalization. Perform lab overview for client tours & internal clients.Define & maintain project timelines using a milestone-driven approach. Track milestone deliverable due dates & organize their completion w/ team members.Analyze complex data, interpret & integrate experimental results with project objectives using JMP statistical software and Excel to analyze and plot data.Host technical workshops or meetings for process development groups. Update group members on background and status of client projects by giving oral updates or internal presentations.Lead mentorship activity in Downstream PD for interns and co-ops, and provide shadowing opportunities to college from other departments.Requires a Ph.D. degree in Chemical Engin and 3 yrs of exp in job offered or 3 yrs of exp as a Sr. Assoc, cGMP Biomanufacturing or any other job title performing the following job duties:Perform basic Downstream purification and mRNA production activities, including in-vitro transcription (IVT) reactions, chromatography, tangential flow filtration (TFF), viral filtration, bulk drug substance filling, and column packing/qualification.Following manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs) and with a focus on \"right-first-time\" execution.Documenting all activities in accordance with Good Documentation Practices (GDPs) in BPRs. Forms, and other quality documentation.Interacting with clients during Person In Plant (PIP) or virtual PIP observations to provide updates on batch schedule and status.Recognizing deviations from the intended procedure and raising awareness through the Rapid Response process.Working closely with manufacturing leadership to help develop processes or techniques to meet contract objectives while avoiding operational delays.Participating in daily shift huddles & leading shift exchange activities. Assess opera ions w/ a critical eye for adherence to cGMPs & improvement opportunities. ***** OTHER EXPERIENCE AND QUALIFICATIONS: Requires a Ph.D. degree in Chemical Engineering and 3 years of experience in job offered or 3 years of experience in the Related Occupation ***** APPLICATION INSTRUCTIONS: Apply Online: www.catalent.com/