Mixed Modality (Peptide Upstream) Scientist - Process Translation and Execution

Position Overview

The Mixed Modality (Peptide Upstream) Scientist will synthetically evaluate and facilitate the transfer of peptide upstream manufacturing processes, under appropriate supervisory guidance, from development laboratories to pilot plant operations (including kilo-scale and isolator production environments). This enables the successful transition to early-phase cGMP manufacturing of grams to kilogram quantities of API required for clinical trial supply.

Responsibilities

• Perform synthetic peptide chemistry and assess synthetic routes from early phase process research and development labs
• Perform peptide upstream procedures such as SPPS and Cleavage & Precipitation
• Evaluate the safety of incoming procedures in collaboration with the safety group and process engineering
• Order and stage chemicals; obtain reference materials and participate in setting up analytical methods
• Reprocess and analyze analytical data to make fact-based decisions
• Summarize and present chemistry and challenges efficiently
• Perform familiarization executions to ensure plant readiness of process steps including SPPS and Cleavage & Precipitation
• Perform use-tests of key raw materials and document Definitive Lab Trials to confirm plant readiness
• Maintain a well-organized and detailed lab notebook with accurate descriptions of chemistry, observations, and organized analytical data
• Author and review technical documents including tech transfer plans, SOPs, batch records, campaign summary reports, and deviation reports
• Apply scientific knowledge to identify areas for improvement and implement new technologies or procedures
• Support process deviations, quality events, and non-conformances; perform root cause analysis and develop CAPAs

Basic Requirements

• B.S. or M.S. in chemistry, chemical engineering, or related field
• 3+ years of experience in peptide chemistry and/or manufacturing environments involving synthetic peptide API or drug substance
• Must be authorized to work in the United States on a full-time basis

Additional Preferences

• Working knowledge of peptide chemistry and mechanisms for reaction improvement and optimization
• Experience with synthetic chemistry techniques for developing and scaling-up chemical reactions
• Experience using process chemistry concepts
• Proficiency with synthesis of peptide crude via solid phase peptide synthesis and cleavage & deprotection
• Comfortable working with larger sized glass equipment
• Highly motivated, able to learn rapidly, strong attention to detail
• Experience creating batch records and conducting scale-up experiments
• Ability to prioritize multiple activities and manage ambiguity
• Experience with analytical techniques: HPLC/UPLC, LC-MS, GC, NMR
• Process quantification and acquiring mass balance for products and by-products
• Demonstrated ability to drive projects and accept change
• Excellent written and verbal communication skills
• Familiarity with peptide downstream purification, TFF, lyophilization, and safe handling of solids/dry end processing
• Proven ability to analyze data, perform root cause analysis, and resolve complex technical challenges
• Ability to work cross-functionally across disciplines and levels