Analytical Scientist I / II

Bachem AG•Torrance, CA

2d•$84,196 - $124,818•Onsite

About The Position

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.

Requirements

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 Troubleshooting instrumentation and training others on proper operation
1+ years’ experience in Feasibility studies, method execution, protocol /report generation and analytical technical transfer
1+ years’ experience in ICH, FDA, USP, and GMP/GLP standards
1+ years’ experience in Maintenance of accurate, detailed records in compliance with GMP/GLP, and draft Standard Operating Procedures (SOPs) and technical reports
1+ years’ experience in Independently analyzing complex data, identification of trends, and resolution of technical issues in routine testing
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
Ability and willingness to work with hazardous materials and chemicals

Nice To Haves

Technical Leadership & Reporting: Serve as a project SME, writing technical reports, SOPs, and other documents as needed (preferred)
Experience with Master Control (preferred)

Responsibilities

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.