Associate Principal Scientist, Process Development

Job Title: Associate Principal Scientist, Process Development
City: Madison
State:  WI

JOB DESCRIPTION: 
1. Initiate, direct, and execute scientific research for innovation and process improvements in protein purification and clinical manufacturing, including investigating new chromatography resin and solution buffer systems, on-boarding new automated chromatography and filtration instruments, validating novel protein purification methods, introducing and evaluating novel affinity/anion exchange/cation exchange/hydrophobic interaction/mix matrix resins.
2. Execute purification experiments including automated chromatography using AKTAready, AKTAavant and AKTAprocess, normal filtration with peristaltic pump, clarification harvest using 3M depth filter and Millipore Pod filter, column packing in lab scale and in pilot scale, and tangential flow filtration on table-top scale and with automatic machine independently.
3. Perform protein purification and analysis of pf all modes of chromatography, including affinity chromatography, anion exchange chromatography, cation exchange chromatography, hydrophobic interaction chromatography and ceramic hydroxyapatite chromatography.
4. Research, develop and characterize existing and new technologies/process in clinical manufacturing downstream process, including performing biomanufacturing downstream process Failure Mode & Effects Analysis (FMEA), characterizing process solutions, investigating product and 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 and re-filtration evaluation, performing viral clearance evaluation, evaluating resin lifetime on protein purification chromatography process, and performing impurity challenge on current protein purification chromatography process.
5. Write complex procedural standard operating procedures (SOP), batch production records, and reports.
6. Act as the technical lead for client development projects, communicate project status internally and externally, and provide technical explanation/rationalization. Perform lab overview for client tours and internal clients.
7. Define and maintain project timelines using a milestone-driven approach. Track milestone deliverable due dates and organize their completion with team members.
8. Analyze complex data, interpret and integrate experimental results with project objectives using JMP statistical software and Excel to analyze and plot data.
9. 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.
10. Lead mentorship activity in Downstream PD for interns and co-ops, and provide shadowing opportunities to college from other departments.

EDUCATION AND EXPERIENCE REQUIREMENT: 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

RELATED OCCUPATION:
Sr. Associate, cGMP Biomanufacturing or any other job title performing the following job duties:

1. 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.
2. 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.
3. Documenting all activities in accordance with Good Documentation Practices (GDPs) in BPRs. Forms, and other quality documentation.
4. Interacting with clients during Person In Plant (PIP) or virtual PIP observations to provide updates on batch schedule and status.
5. Recognizing deviations from the intended procedure and raising awareness through the Rapid Response process.
6. Working closely with manufacturing leadership to help develop processes or techniques to meet contract objectives while avoiding operational delays.
7. Participating in daily shift huddles and leading shift exchange activities.
8. Assessing operations with a critical eye for adherence to cGMPs and improvement opportunities.

JOB TIME:  Full Time

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

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Catalent is an Equal Opportunity Employer, including disability and veterans.

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