Peptide Downstream Scientist: Transfer & Scale-Up

Jobtailor; Lebanon (Lebanon County); On-site; USD 90,000 - 150,000; Full time

Job description

• Evaluate and facilitate transfer of peptide downstream manufacturing processes from development laboratories to pilot plant operations, including kilo-scale and isolator production environments
• Perform peptide purification and isolation and assess purification methods
• Perform peptide downstream procedures including reverse-phase chromatography, TFF, lyophilization, and precipitation and drying
• Evaluate safety of incoming procedures with safety and process engineering groups
• Order and stage chemicals and obtain reference materials
• Participate in setting up analytical methods
• Reprocess and analyze analytical data to support fact-based decisions
• Summarize and present chemistry and technical challenges
• Perform familiarization executions to ensure plant readiness of process steps
• Perform use-tests of key in-process materials and document Definitive Lab Trials
• Maintain detailed lab notebooks and organized analytical data for technical packages and technical transfers
• Author and review technical transfer plans, SOPs, batch records, campaign summary reports, and deviation reports
• Identify process improvements and implement new technologies or procedures
• Support process deviations, quality events, non-conformances, root cause analyses, and CAPAs
• Collaborate cross-functionally to support clinical manufacturing readiness at the Lilly Medicine Foundry

Requirements

• B.S. or M.S. in chemistry, chemical engineering, or a related field
• 3+ years of experience in synthesis peptide purification and/or manufacturing environments involving synthetic peptide API or drug substance
• Qualified applicants must be authorized to work full-time in the United States
• Reverse-phase chromatography preferred
• Working knowledge of peptide downstream chemistry and purification
• Experience developing and scaling up chemical reactions using peptide purification techniques
• Proficiency with peptide purification via chromatography and TFF, plus downstream conjugation and cyclization
• Comfortable working with larger preparative columns, TFF, and related equipment
• Experience creating batch records and conducting scale-up experiments
• Experience with HPLC/UPLC, LC-MS, GC, NMR, and related analytical techniques
• Experience with process quantification and mass balance for products and by-products
• Familiarity with peptide upstream synthesis and cleavage, precipitation, and safe handling of solids/dry-end processing
• Ability to analyze data, perform root cause analysis, and resolve technical challenges
• Ability to work cross-functionally with engineers, analytical chemists, chemical technicians, safety, and quality representatives
• Ability to work in manufacturing and laboratory environments
• Limited domestic and international travel under 5% may be required

Core Competencies

Demonstrates expertise in peptide purification and downstream manufacturing processes, including reverse-phase chromatography and TFF. Proficient in analytical techniques such as HPLC/UPLC and LC-MS, with a strong ability to analyze data and implement process improvements.

Highest-signal resume keywords

• Peptide Purification
• Reverse-Phase Chromatography
• TFF (Tangential Flow Filtration)
• HPLC/UPLC
• Analytical Data Analysis

ATS Optimization Keywords

Hard Skills

• Peptide Downstream Chemistry
• Batch Record Creation
• Process Quantification
• Mass Balance Analysis
• Root Cause Analysis

Soft Skills

• Cross-Functional Collaboration
• Problem Solving

Industry Keywords

• Synthetic Peptide API
• Drug Substance
• Technical Transfer Plans
• SOPs
• Quality Events

Tools & Technologies

• LC-MS
• GC
• NMR