QC Scientist ; Bioassay

Position: QC Scientist I (Bioassay)
Job Title:

QC Scientist I (Bioassay)

Job Description

The QC Scientist I (Bioassay) supports Good Manufacturing Practice (GMP) manufacturing by performing analytical testing for commercial products and stability studies in a cGMP laboratory environment. You will use a range of analytical tools for large molecule analysis, including compendial methods, enzyme activity assays, and bioassays, to ensure timely and accurate testing of in-process, drug substance release, and stability samples.

This role offers structured training, exposure to advanced analytical technologies, and the opportunity to grow within a collaborative, development-focused culture.

Responsibilities

* Perform ELISA, compendial testing (pH, UV, osmolality, appearance), enzyme activity assays (including temperature and incubation parameters), and other bioassays on in-process, drug substance release, and stability samples to support GMP manufacturing and stability programs.

* Operate analytical instruments such as spectrometers, plate readers, and other minor laboratory equipment to execute assigned test methods accurately and efficiently.

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

* Compile, analyze, and interpret test data, document results according to Standard Operating Procedures, and prepare clear and accurate reports.

* Review laboratory data packets as assigned to ensure completeness, accuracy, and compliance with applicable procedures and regulations.

* Perform and author laboratory investigations, including out-of-specification (OOS) and out-of-trend (OOT) assessments, as assigned by laboratory leadership.

* Recognize and promptly report invalid results, laboratory incidents, and out-of-specification or out-of-trend results to laboratory management, and recommend appropriate corrective actions or solutions.

* Contribute to the development and optimization of new analytical concepts, techniques, and standards to improve laboratory efficiency and data quality.

* Collaborate closely with team members, quality assurance, and data reviewers to ensure alignment, resolve issues, and maintain high-quality standards.

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

* Participate in routine laboratory activities, including safety inspections, housekeeping, and ordering or managing laboratory supplies.

* Engage fully in the structured training program by successfully completing required testing qualifications on each method before progressing to additional assays.

Essential Skills

* At least 1 year of proven experience working in a GMP regulated environment, including hands-on ELISA testing.

* Demonstrated experience performing compendial testing such as pH, UV, osmolality, and appearance measurements.

* Practical experience conducting enzyme activity assays, including control of temperature, incubation, and other critical parameters.

* Proficiency in operating spectrometers and plate readers for quantitative and qualitative analyses.

* Strong qualitative pipetting skills, including accurate and consistent pipetting technique.

* Ability to conduct GMP testing using HPLC and UPLC methods, including reverse phase, SEC, concentration measurements, and CEX, in an analytical laboratory setting.

* Working knowledge of EMPOWER or similar chromatography data systems and familiarity with MS Office and laboratory computer programs.

* Bachelor's degree in pharmaceutical sciences, biology, chemistry, biotechnology, or a related scientific field.

* Strong organizational and planning skills, with the ability to manage multiple tasks in a regulated environment.

* High attention to detail and accuracy in data recording, documentation, and review.

* Flexible, positive, and collaborative approach to working in a team-based laboratory setting.

Additional

Skills & Qualifications

* Experience with SoloVPE for concentration or related measurements.

* Familiarity with qPCR techniques and workflows.

* Hands-on experience with colorimetric assays such as Picogreen and Bradford.

* Experience working with 96-well plates and multi-channel pipettes for high-throughput testing.

* Exposure to peer data review processes in a quality control environment.

* Experience conducting or contributing to investigations, including out-of-specification (OOS) and out-of-trend (OOT) assessments.

* Experience in quality control, wet chemistry, bioassays, and UV-Vis analytical techniques.

* Strong general computer literacy and comfort working with laboratory information and documentation systems.

* Demonstrated ability to adapt to changing priorities and learn new methods and technologies quickly.

Work Environment

This position is based in a pharmaceutical quality control laboratory where you will perform…