Sigma
Associate Quality Scientist
The Associate Quality Scientist position will be responsible for safely performing operations that support our manufacturing departments as well as performing stability/release testing (DS/DP) and other customer requests. The candidate will be expected to meet and exceed customer and regulatory body quality expectations for a current Good Manufacturing Practice (cGMP) facility, as well as understand how continuous improvements help us achieve our departmental goals by increasing efficiencies. The position is within the ADC Stability and Release team. It involves testing in accordance with GMP requirements in a laboratory environment, which is routinely audited by customers and regulatory agencies. The Associate Quality Scientist may actively participate in audits and assist in resolving any audit findings. Shift: Monday-Friday 10pm to 6:30am. Perform timely analytical and microbiological (endotoxin) testing to support cGMP in-process, release, and stability of drug substances and products. Review in-process microbiology data to ensure accuracy and compliance. Ensure adherence to GMP and GDP requirements through accurate documentation and quality practices. Conduct advanced troubleshooting using technical knowledge to resolve issues and propose logical solutions. Communicate status of operations, escalate deviations, and meet departmental goals and deadlines. Support lab operations by maintaining equipment, preparing reagents, managing inventory, and handling waste. Maintain complete, accurate records aligned with quality standards and regulatory guidelines. Physical Attributes: Additional needs may include the use of personal protective equipment such as a respirator or chemical protective clothing for extended periods of time. Occasional lifting and pushing up to 40 pounds. Who You AreMinimum Qualifications: Bachelor's Degree in Chemistry, Biochemistry, Biology or other Life Science discipline. 1+ years of lab testing experience. OR Associate's Degree in Chemistry, Biochemistry, Biology, other Life Science discipline. 3+ years of analytical testing experience in a cGMP laboratory environment. Preferred Qualifications: Antibody drug conjugate (ADC) experience Instrument experience such as UV, HPLC, GC, LCMS, UV, Solo VPE, CGE, and iCE is highly desirable. Analytical capabilities, GDP and Data integrity and ALCOA. Experience with Trackwise, Chromeleon, LIMS and SAP. Familiarity with general laboratory instrumentation and troubleshooting capabilities for when problems occur; for example, identifying instrumental errors or subtleties in technique. Able to excel in a team setting in a dynamic environment where shifting priorities are not uncommon. Knowledge of safe chemical handling methods. Strong oral and written communication skills. Ability to accurately perform procedures independently.
The Associate Quality Scientist position will be responsible for safely performing operations that support our manufacturing departments as well as performing stability/release testing (DS/DP) and other customer requests. The candidate will be expected to meet and exceed customer and regulatory body quality expectations for a current Good Manufacturing Practice (cGMP) facility, as well as understand how continuous improvements help us achieve our departmental goals by increasing efficiencies. The position is within the ADC Stability and Release team. It involves testing in accordance with GMP requirements in a laboratory environment, which is routinely audited by customers and regulatory agencies. The Associate Quality Scientist may actively participate in audits and assist in resolving any audit findings. Shift: Monday-Friday 10pm to 6:30am. Perform timely analytical and microbiological (endotoxin) testing to support cGMP in-process, release, and stability of drug substances and products. Review in-process microbiology data to ensure accuracy and compliance. Ensure adherence to GMP and GDP requirements through accurate documentation and quality practices. Conduct advanced troubleshooting using technical knowledge to resolve issues and propose logical solutions. Communicate status of operations, escalate deviations, and meet departmental goals and deadlines. Support lab operations by maintaining equipment, preparing reagents, managing inventory, and handling waste. Maintain complete, accurate records aligned with quality standards and regulatory guidelines. Physical Attributes: Additional needs may include the use of personal protective equipment such as a respirator or chemical protective clothing for extended periods of time. Occasional lifting and pushing up to 40 pounds. Who You AreMinimum Qualifications: Bachelor's Degree in Chemistry, Biochemistry, Biology or other Life Science discipline. 1+ years of lab testing experience. OR Associate's Degree in Chemistry, Biochemistry, Biology, other Life Science discipline. 3+ years of analytical testing experience in a cGMP laboratory environment. Preferred Qualifications: Antibody drug conjugate (ADC) experience Instrument experience such as UV, HPLC, GC, LCMS, UV, Solo VPE, CGE, and iCE is highly desirable. Analytical capabilities, GDP and Data integrity and ALCOA. Experience with Trackwise, Chromeleon, LIMS and SAP. Familiarity with general laboratory instrumentation and troubleshooting capabilities for when problems occur; for example, identifying instrumental errors or subtleties in technique. Able to excel in a team setting in a dynamic environment where shifting priorities are not uncommon. Knowledge of safe chemical handling methods. Strong oral and written communication skills. Ability to accurately perform procedures independently.