Analytical Scientist III at Bachem Americas, Inc. – Vista, California

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status
Bachem Americas, Inc.

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.

A brief overview

The role of Analytical Scientist III 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 5+ years relevant industry experience or
• PhD in related field with 3+ years relevant industry experience (Master's or PhD preferred)
• 5+ 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
• 5+ years' experience (3 years with PhD) 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)

Base salary range:

Scientist III: $97,472 - $134,024

Sr. Scientist: $106,320 - $146,190

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

 Corporate Social Responsibility

 Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees' environmental awareness.EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. 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.