Principal Scientist, Method Development & Validation

A brief overview

 

The Principal Scientist, Method Development & Validation will fulfill a critical role in QC GMP operations. This individual helps to guide development of release/stability and in-process analytical methods for all peptide drug substances/finish products and raw materials at Bachem America sites. The individual will work closely together mainly with process development, production manufacturing, QC material testing, QC IPC, and QC API testing to understand and align analytical strategies. This individual will support method development, validation, and method transfer, including authoring technical quality documents (method, protocols, reports, etc.), execution of protocols and review of data and technical documents.

 

In addition, this individual performs special projects such as peptide characterization, impurity identification, and other special studies as necessary. This individual conducts or contributes to investigations and the identification and implementation of corrective actions. This individual contributes to advances in analytical capabilities and innovations for the Quality Control department. This individual proactively provides solutions to resolve analytical challenges to support our internal and external customers in a timely manner. The individual should ultimately define and implement best practices within QC.

 

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
• 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

 

Qualifications

 

• 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.

 

 

Base salary range: $131,246