Analytical Scientist, Method Development & Validation

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

In order to continue our organic growth, we are constantly looking for talent.

Your Responsibilities

The Analytical Scientist will fulfill a critical role in GMP operations. This individual helps with the

execution of feasibility evaluation of analytical methods, method development and validations, writing

of validation protocols, reports and other technical quality documents; conducts validation related

investigations and contributes to improvements in laboratory operations.

Your Tasks

• 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
• Under minimal supervision, conduct and document investigations related to validation activities
• Contribute to GMP systems improvement
• Routinely work with hazardous materials and manage hazardous waste in a satellite
• accumulation area
• Develop and maintain in-depth understanding of the scientific principles associated with analytical methods being developed, optimized, transferred, validated, and qualified

Your Profile

• Master’s Degree in analytical chemistry or related scientific field along with a minimum of 1 year of experience in analytical method validation in GMP laboratory
• Bachelor’s Degree in analytical chemistry or related scientific field along with a minimum of 3 years of experiences in analytical method validation in GMP laboratory
• Knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)
• Hands-on experiences with analytical instrumentation and technique, including HPLC (SEC, IC)/UPLC, GC, KF, Amino Acid Analysis, and LC-MS, UV-Vis, FT-IR, etc.
• Hands-on experiences with wet chemistry testing
• Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations they undergo. This includes the use of chemicals and their interactions, danger signs, production techniques, and disposal methods
• Experience in writing standard operating procedures (SOPs), test methods, and technical protocols and reports
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Capable of working methodically and adhering to rules and regulations
• Ability to set priorities and to follow through on commitments
• Excellent written and oral communication skills with the ability to function well in team environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to work independently and manage one’s time to meet deadline

Preferred:

• Thorough knowledge and understanding of microbiology, especially in bacterial endotoxin and bioburden testing and validation
• Experience with peptides
• Experience with pharmaceutical analysis

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are

looking for a new challenge and want to join a motivated team in an internationally renowned company,

you should seize this opportunity.