QC Compendial Scientist

Position: QC Compendial Scientist I
Job Title:

QC Compendial Scientist I

Job Description

The QC Compendial Scientist I supports Good Manufacturing Practice (GMP) manufacturing by performing compendial and analytical testing for commercial product release and stability programs. You will work in a cGMP-regulated laboratory, using a variety of analytical tools for large molecule analysis to ensure high-quality data, timely delivery of results, and compliance with established procedures. This entry-level role offers extensive training, ongoing learning, and the opportunity to contribute to new concepts, techniques, and standards in a collaborative and growth-oriented environment.

Responsibilities

+ Perform compendial testing for large molecule analysis, including pH, UV, osmolality, and related methods, on in-process, drug substance (DS) release, and stability samples to support GMP manufacturing and stability programs.

+ Operate and maintain analytical instruments such as spectrometers, plate readers, SoloVPE, and other minor laboratory equipment to execute routine and specialized test methods.

+ Conduct GMP testing in an analytical laboratory using HPLC and UPLC test methods, including reverse phase, size-exclusion chromatography (SEC), concentration assays, cation-exchange chromatography (CEX), and related techniques.

+ Perform colorimetric and other biochemical assays, such as Picogreen and Bradford assays, as required to support analytical testing of large molecules.

+ Execute qualitative pipetting and, when applicable, multi-channel and 96-well plate pipetting techniques to ensure accurate and precise sample preparation.

+ Compile and analyze data generated from testing, document test procedures accurately, and prepare clear, concise reports in accordance with laboratory and quality requirements.

+ Review laboratory data packets as assigned, ensuring completeness, accuracy, and compliance with applicable procedures and regulatory expectations.

+ Author and perform laboratory investigations as assigned, including root cause analysis and documentation of findings in alignment with quality standards.

+ Recognize and promptly report invalid results, laboratory incidents, out-of-specification (OOS), and out-of-trend (OOT) results to laboratory management, and recommend appropriate corrective actions.

+ Contribute to the development and refinement of new concepts, techniques, and standards within the QC laboratory to improve efficiency, robustness, and quality of testing.

+ Collaborate closely with team members, quality assurance, and data reviewers to ensure alignment on testing priorities, data review, and resolution of issues.

+ Perform all duties in compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and safety guidelines to maintain a compliant and safe laboratory environment.

+ Participate in routine laboratory activities, including safety inspections, housekeeping, and ordering supplies to support smooth and efficient laboratory operations.

+ Engage in training on all assays during the initial months and apply learned techniques to independently perform assigned tests once qualified.

+ Volunteer and sign up for periodic specialized tests that occur approximately every six weeks, adjusting work schedules as needed to support these time-sensitive activities.

Essential Skills

+ Ability to perform compendial testing, including pH, UV, and osmolality measurements, in a GMP-regulated laboratory environment.

+ Hands-on experience or training with spectrometers and plate readers for analytical testing.

+ Proficiency in qualitative pipetting techniques with strong attention to accuracy and precision.

+ Foundational understanding of biochemistry and wet chemistry principles relevant to large molecule analysis.

+ Ability to follow cGMP requirements and Standard Operating Procedures in a laboratory setting.

+ Strong organizational and planning skills to manage multiple tests and timelines effectively.

+ High attention to detail in executing test methods, recording data, and reviewing documentation.

+ Positive, collaborative demeanor with the ability to work effectively within a small team.

+ Flexibility to adapt to…