Scientist

About This Role

This scientist role involves performing advanced diagnostic testing and analysis, ensuring the accuracy and reliability of laboratory results, troubleshooting complex technical issues, and contributing to the continuous improvement of lab procedures and quality standards. The work makes a positive impact on a global scale, enabling customers to make the world healthier, cleaner, and safer.

Responsibilities

• Perform a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in various formulations and/or biological matrices for stability and analytical testing
• Work with multiple functional groups to meet business needs
• Plan and organize work with periodic supervision
• Set up and maintain analytical instrumentation
• Train in routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines
• Ensure QA findings are addressed appropriately
• Provide assistance and training for other team members
• Problem solve, either independently or with assistance, pertaining to extraction and/or instrumentation problems
• Communicate project status to project leader
• Perform work assignments accurately, and in a timely and safe manner
• Review, interpret, and analyze data for technical, quality, and compliance to protocols, methods, SOPs, client criteria, and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP)
• Perform self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers

Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
• Strong background and hands-on experience in large molecule bioanalysis and ligand-binding immunoassays (LBA)
• Hands-on experience with MSD/ECL-based assays and MSD instruments
• Experience in PK and ADA assay sample analysis, data processing, and data review
• Demonstrated experience working in a GLP-regulated bioanalytical laboratory, with a good understanding of applicable SOPs, data integrity, and regulatory requirements
• Ability to independently execute analytical methods and perform assay troubleshooting and investigation
• Strong data interpretation, technical writing, communication, and problem-solving skills
• Proficiency in Microsoft Excel and Word
• Ability to effectively manage multiple tasks and work both independently and collaboratively within a team

Nice to have: