Analytical Scientist I/II

A brief overview

The role of Analytical Scientist is to develop release/stability and in-process analytical methods for all peptide drug substances/finish products and raw materials at Bachem America sites. This individual will support method development, validation, and method transfer, including authoring of technical quality documents (method, protocols, reports, etc) and execution of protocols. 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.

What you will do

• Develop analytical methods for the QC department in coordination with the QC Director/Management for testing of in-process, raw material and peptides (API's). Analytical methodologies may include but not limited to MS, HPLC, UPLC, SEC, GC-MS, LC-MS, KF among others.
• Conduct method validation/analytical transfer of analytical methods between Bachem sites and external testing sites. Activities will include conducting feasibility studies and method validations generation of protocols and reports in support of such activities.
• Write and work with other QC Staff in the creation and approval of control documents such as specifications, SOPs, STMs, etc.
• Support all investigational issues in QC with analytical projects and support activities.
• Follow safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals
• Provide guidance and assistance to peers and junior scientists for troubleshooting abnormal results; conduct and support laboratory investigations.

Qualifications

• Bachelor’s degree in chemistry or related field with 1+ years relevant industry experience
• 1+ years’ experience in Method Development & Validation: 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
• 1+ years’ experience in the following:
  • Troubleshooting instrumentation and training others on proper operation
  • Feasibility studies, method execution, protocol /report generation and analytical technical transfer
  • ICH, FDA, USP, and GMP/GLP standards
  • Maintenance of accurate, detailed records in compliance with GMP/GLP, and draft Standard Operating Procedures (SOPs) and technical reports
  • Independently analyzing complex data, identification of trends, and resolution of technical issues in routine testing
  • Technical Leadership & Reporting: Serve as a project SME, writing technical reports, SOPs, and other documents as needed (preferred)

Additional qualifications:

• Knowledge of current Good Manufacturing and Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
• Ability to perform as an independent scientist in analytical methodology with supervision
• Ability to take the technical lead working with other scientists
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Communicate effectively and ability to function well in a team environment
• Flexibility of working hours based on business needs, may include some nights and occasional weekends
• Ability and willingness to work with hazardous materials and chemicals
• Experience with Master Control (preferred)