Principal Scientist, Method Development & Validation

Responsibilities

• Independently design, implement, and optimize advanced analytical methods and control strategies for peptide API and raw material testing.
• Plan and execute validation studies, including the authoring of validation protocols, final reports, and standard operating procedures (SOPs).
• Lead analytical method transfers to the Quality Control Department.
• Provide technical leadership, guidance, and training to junior scientists, peers, and QC analysts.
• Conduct investigations related to validation activities and contribute to the improvement of GMP systems.
• Perform special projects such as peptide characterization and impurity identification.
• Recommend and implement improvements to laboratory operations and analytical capabilities.

Requirements

• B.S. in chemistry or a related scientific field with 15+ years of industry experience, or M.S. with 15+ years, or Ph.D. with 12+ years.
• 10+ years of extensive experience in Method Development & Validation.
• 3+ years of experience working within a GMP environment.
• 10+ years of experience with ICH, FDA, USP, and GMP/GLP standards.
• Expert hands-on proficiency with HPLC, UPLC, LC-MS, GC-MS, MS-MS, and KF.
• Proven ability to analyze complex data, identify trends, and resolve technical issues.
• Strong technical writing skills for protocols, reports, and SOPs.
• Excellent communication and organizational skills in a fast-paced, deadline-driven environment.

Preferred Qualifications

• Experience specifically with Peptides.
• Experience using Master Control or Veeva.
• Experience with automation and implementing new instrumentation or test strategies.

Benefits

• Competitive base salary ($131,246 - $180,463).
• Annual performance bonus.
• Comprehensive Medical, Dental, and Vision coverage.
• 401(k) plan with employer contribution.
• Paid vacation, personal, and sick days.

About the Company

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of expertise, Bachem provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide.