Principal Research Scientist I, Peptide Manufacturing Process Development

Role Summary

Principal Research Scientist I, Peptide Manufacturing Process Development. Conduct late-stage development and commercialization of Peptides, from registration through commercialization and the product lifecycle. Work in a multi-functional team environment at North Chicago, IL.

Responsibilities

• The candidate will contribute to and/or lead cross-functional project teams associated with manufacturing process development, process characterization/justification, transfer of technology to manufacturing sites, and support manufacturing activities for peptides and potentially other modalities.
• Provide leadership in a matrixed team setting, acting as an SME for peptide processes, interacting with cross-functional groups and stakeholders, and contributing to peptide manufacturing strategies.
• Set project strategies, define project responsibilities and timelines.
• Author and review key regulatory documents, laboratory data, technical memos and reports.
• Interact with organic chemists, analytical chemists, engineers, and solid-state scientists; interface with groups external to PDS&T (e.g., Manufacturing Operations, Regulatory Affairs, Quality Assurance).

• Function as a principal investigator, generating original technical ideas and solving problems to champion new technologies and achieve project goals. Contribute to project teams through lab-based work; independently responsible for project science within area of expertise.
• Author/review technical reports, manufacturing batch records, and regulatory documents concerning CMC; primary author of publications, presentations, and/or primary inventor of patents.
• Potential to mentor/supervise a team; evaluate performance and ensure effective team performance.
• Generate new scientific proposals and lead those efforts; anticipate scientific/regulatory advances or competitive threats and respond with new strategies.

Qualifications

• Bachelor‚Äôs Degree or equivalent; typically 14+ years of experience; Master‚Äôs 12+ years; PhD 6+ years in organic chemistry with focus on peptide synthesis. Candidates with less experience may be considered for other opportunities.
• Experience in peptide process development and commercialization.
• Broad expertise in modern organic chemistry, mechanistic understanding, compound purification, control strategy development, and standard analytical methods (e.g., HPLC, UPLC, LC-MS, NMR).
• Demonstrated scientific communication and presentation skills; experience as author of publications, presentations, and/or primary inventor of patents.
• Strong interpersonal and communication skills for facilitating collaborations and leading cross-functional process development teams.

Skills

• Peptide manufacturing processes
• Process development, characterization, technology transfer
• Regulatory documentation and CMC familiarity
• Cross-functional collaboration and project leadership
• Analytical techniques: HPLC, UPLC, LC-MS, NMR

Education

• PhD in Organic Chemistry (peptide synthesis) or equivalent advanced degree preferred; relevant industry experience considered.