Research Associate / Scientist in Peptide API Development

Key Responsibilities

• Design and execute peptide synthesis processes (SPPS / solution phase / hybrid approaches)

for API development.

• Optimize reaction conditions, resin selection, coupling strategies, and cleavage protocols to

achieve high yield, purity and productivity.

• Develop and validate purification processes (prep HPLC/UPLC, crystallization, lyophilization).
• Conduct analytical characterization of intermediates and final peptide APIs using HPLC, LC-

MS, NMR, FT-IR and other relevant techniques.

• Support process scale-up from lab to pilot/plant scale, ensuring reproducibility and

regulatory compliance.

• Prepare process development reports, technology transfer documents, and regulatory

submissions (CMC sections).

• Ensure adherence to GMP, ICH, USFDA, EMA, and other regulatory guidelines.
• Collaborate closely with Process Engineering, Production, QA, QC, and Regulatory Affairs

for successful API development.

• Troubleshoot technical challenges during development and scale-up.

Qualifications

• Education: M.Sc / M.Tech / Ph.D. in Organic Chemistry, Peptide Chemistry, Medicinal

Chemistry, Biochemistry, or related field.

Experience:

• 1 to 3 years (Research Associate Entry level)

• 3 to 6 years (Scientist Mid-level)

• 6+ years (Senior Scientist Lead level)

• Strong hands-on experience in peptide API process development, purification, and scale-

up.

• Knowledge of regulatory expectations for APIs and CMC documentation preferred.

Desired Skills

• Expertise in solid-phase and solution-phase peptide synthesis.
• Experience in process optimization, scale-up, and technology transfer.
• Familiarity with ICH Q7, GMP guidelines, and regulatory frameworks.
• Strong analytical and troubleshooting skills.
• Proficiency with analytical instruments (HPLC, LC-MS, NMR).
• Excellent communication, documentation, and teamwork skills.
• Innovative mindset to stay updated on the latest trends in peptide chemistry for creating IP

wealth.

Key Competencies

• Scientific rigor and attention to detail.
• Ability to manage multiple projects and timelines.
• Strong problem-solving and process improvement mindset.
• Commitment to safety, compliance, and quality.

shikha.mishra@walterbushnell.com