Principal Scientist, Method Development & Validation
A critical role in QC GMP operations, guiding the development of release/stability and in‑process analytical methods for peptide drug substances and finished products, as well as raw materials at Bachem America sites. Works closely with process development, production, QC material testing, QC IPC, and QC API testing teams to align analytical strategies, support method development, validation, transfer, and author technical quality documents.
A Brief Overview
Supports special projects such as peptide characterization, impurity identification, and other studies. Contributes to investigations, corrective actions, and advances analytical capabilities, proactively providing solutions to resolve analytical challenges for internal and external customers.
What you will do
* Independently design and implement advanced analytical methods and control strategies for peptide API and raw material testing using techniques such as HPLC, UPLC, LC‑MS, GC‑MS, SEC, KF, and others as needed
* Plan and execute validation studies for test methods
* Implement and perform analytical method transfer to Quality Control Department
* Write validation protocols and final reports, test methods, standard operating procedures, and technical reports
* Provide guidance and training to junior MDV Scientists, peers and Quality Control analysts
* Work with hazardous materials and manage hazardous waste in a satellite accumulation area
* Build or expand analytical capabilities as needed
* Recommend and implement improvements to methods, laboratory operations and evaluate potential equipment for analytical purposes
* Conduct and document investigations related to validation activities
* Contribute to GMP systems improvement
* Develop and maintain in‑depth understanding of the scientific principles of analytical methods being developed, optimized, transferred, validated, and qualified
Qualifications
* B.S. in chemistry or related scientific field with 15+ years of industry experience
* M.S. in chemistry or related scientific field with 15+ years of industry experience
* Ph.D. in chemistry or related scientific field with 12+ years of industry experience (preferred)
* 3+ years of experience in a GMP environment
* 10+ years of experience in Method Development & Validation, including hands‑on work with LC‑MS, UPLC, HPLC, GC‑MS, MS‑MS, KF and other routine analytical methodologies in a deadline‑driven environment
* Experience with peptides (preferred)
* 10+ years of experience with ICH, FDA, USP, and GMP/GLP standards
* 10+ years of experience independently analyzing complex data, identifying trends, and resolving technical issues in routine testing
* 7+ years of experience in Technical Leadership & Reporting, serving as a project SME and providing analytical support to internal and external customers
* Experience with Master Control or Veeva (preferred)
* Extensive hands‑on experience with HPLC (SEC, IC)/UPLC, GC, KF, Amino Acid Analysis, MS, MS/MS sequencing and LC‑MS
* Extensive experience in troubleshooting instrumentation, training others, and implementing best practices
* Experience writing SOPs, test methods, technical protocols, reports and other documents in compliance with GMP/GLP
* Excellent written and oral communication skills
* Ability to organize, multitask, and work in a fast‑paced, timeline‑driven environment
* Experience evaluating and implementing innovation projects (new test strategies, automation, instrumentation, etc.)
* Ability to coordinate work with other functions/departments to achieve project objectives
* Ability to provide expertise to management and project leaders on method feasibility and risk assessment
Base Salary Range
$131,246 - $180,463
Total Rewards
Competitive pay, annual performance bonus, comprehensive medical/dental/vision coverage, 401(k) plan with employer contribution, paid vacation, personal and sick days.
Bachem Americas is an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.
#J-18808-Ljbffr