Principal Scientist, Method Development – Validation
Bachem
full-time
Posted on:
Location Type: Office
Location: San Diego • California • United States
Visit company websiteExplore more
Salary
💰 $131,246 - $180,463 per year
Job Level
About the role
- 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
- Independently 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
- Routinely work with hazardous materials and manage hazardous waste in a satellite accumulation area
- Build or expand the analytical capabilities as needed. Recommend and implement improvements to methods, laboratory operations and assist in evaluating the need of any potential equipment for analytical purposes.
- Independently conduct and document investigations related to validation activities
- Contribute to GMP systems improvement
- Develop and maintain in-depth understanding of the scientific principles associated with analytical methods being developed, optimized, transferred, validated, and qualified
Requirements
- B.S. in chemistry or related scientific field with 15+ years’ industry experience
- M.S. in chemistry or related scientific field with 15+ years’ industry experience
- Ph.D. in chemistry or related scientific field with 12+ years’ industry experience (preferred)
- 3+ years’ experience in a GMP environment
- 10+ years’ experience in Method Development & Validation: extensive hands-on experience in method development, optimization, and validation of methods using the following instrumentation: 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’ experience with ICH, FDA, USP, and GMP/GLP standards.
- 10+ years’ experience independently analyzing complex data, identification of trends, and resolution of technical issues in routine testing.
- 7+ years’ experience in Technical Leadership & Reporting: Serve as a project SME, providing analytical support to internal and external customers.
- Experience with use of 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 and training others and implementation of best practices.
- Experience in writing standard operating procedures (SOPs), test methods, technical protocols, reports and other documents in compliance with GMP/GLP
- Excellent written and oral communication skills
- Ability to effectively organize, multitask, and work in a fast-paced, timeline driven work environment.
- Experience in evaluation and implementation of 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, technical project leaders, project/program leaders on method feasibility and risk assessment.
Benefits
- competitive pay
- annual performance bonus
- a generous benefit package with comprehensive Medical/Dental/Vision coverage
- 401(k) plan with employer contribution
- paid vacation, personal and sick days
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
HPLCUPLCLC-MSGC-MSSECKFmethod developmentmethod validationdata analysistroubleshooting
Soft Skills
communicationorganizational skillsmultitaskingtechnical leadershiptrainingproject managementproblem-solvingcollaborationguidanceinnovation
Certifications
B.S. in chemistryM.S. in chemistryPh.D. in chemistryGMP certificationGLP certification