QC Scientist II (Bioassay)
5 days ago
Saint Louis
Job DescriptionJob Title: QC Scientist II (Bioassay) Job Description The QC Scientist II (Bioassay) supports cGMP manufacturing by performing and reviewing bioassay and compendial testing for commercial product release, in-process control, and stability studies for large molecule therapeutics. This role uses a wide range of analytical tools and techniques in a regulated laboratory environment, contributes to investigations and method execution, and collaborates closely with quality and analytical teams to ensure accurate, timely, and compliant data delivery. Responsibilities • Perform ELISA, compendial testing (including pH, UV, and osmolality), enzyme activity assays (including temperature and incubation-based assays), and other bioassay methods on in-process, drug substance release, and stability samples, ensuring results are delivered within project timelines., • Operate and maintain analytical instruments such as spectrometers, plate readers, SoloVPE, and other minor laboratory equipment according to established procedures., • Conduct GMP testing using HPLC and UPLC methods, including techniques such as reverse phase chromatography, size-exclusion chromatography (SEC), protein concentration assays, and cation-exchange chromatography (CEX)., • Compile, analyze, and interpret test data, prepare clear and accurate documentation of test procedures, and generate reports in accordance with cGMP and internal standards., • Review laboratory data packets as assigned, ensuring completeness, accuracy, and compliance with applicable procedures and regulatory expectations., • Author and perform laboratory investigations, including out-of-specification (OOS), out-of-trend (OOT), invalid tests, and laboratory incidents, and support identification of root cause and corrective actions., • Recognize and promptly report invalid results, laboratory incidents, out-of-specification results, and out-of-trend data to laboratory management, and recommend appropriate next steps or solutions., • Contribute to the development and refinement of new concepts, techniques, and analytical standards within the QC laboratory., • Collaborate closely with team members, quality assurance, and data reviewers to ensure alignment on testing priorities, data quality, and documentation requirements., • Perform all activities in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, and applicable safety guidelines., • Participate in routine laboratory activities, including safety inspections, housekeeping, and ordering or managing laboratory supplies., • Use qualitative pipetting techniques, including 96-well plate and multichannel pipetting where applicable, to support high-throughput or plate-based assays., • Support peer data review and documentation checks, as needed, to maintain high standards of data integrity and traceability.Essential Skills, • Bachelor’s degree in chemical pharmaceutical sciences, biology, chemistry, biotechnology, or a closely related scientific field., • 1–4 years of proven experience working in a GMP-regulated environment, preferably within the pharmaceutical industry., • Hands-on experience with compendial methods, including pH measurement, osmolality, and UV-based testing for large molecule analysis., • Demonstrated proficiency in ELISA and other bioassay techniques used for large molecule characterization., • Experience performing enzyme activity assays, including temperature- and incubation-dependent methods., • Practical experience operating spectrometers and plate readers in a QC or analytical laboratory setting., • Strong qualitative pipetting skills, with accurate and consistent technique suitable for regulated testing., • Working knowledge of cGMP principles and FDA or similar regulatory expectations for analytical laboratories., • Ability to compile, interpret, and document analytical data in a clear, accurate, and compliant manner., • Proficiency with MS Office applications and laboratory computer programs used for data entry, documentation, and reporting., • Strong attention to detail, with the ability to identify data anomalies and potential issues in test results., • Good organization and planning skills to manage multiple tests and priorities in a fast-paced environment., • Flexible, positive, and collaborative approach to working within a team-based laboratory setting.Additional Skills & Qualifications, • Experience with SoloVPE for protein concentration or related applications., • Experience with qPCR methods in a regulated laboratory environment., • Familiarity with colorimetric assays such as Picogreen and Bradford for quantification and characterization of biomolecules., • Experience with 96-well plate and multichannel pipetting techniques for high-throughput or plate-based assays., • Prior experience performing peer data review in a QC or analytical laboratory., • Experience authoring or supporting investigations, including out-of-specification (OOS) and out-of-trend (OOT) events., • Prior use of EMPOWER chromatography data software for HPLC or UPLC data acquisition and analysis., • Experience with wet chemistry techniques and UV-Vis analysis in a quality control environment., • Previous work in bioassay-focused QC laboratories supporting biologics or large molecule products., • Demonstrated ability to work effectively in cross-functional teams and contribute to a collaborative culture., • Ability to adapt to new methods, instruments, and procedures as the laboratory evolves., • Strong communication skills, including the ability to explain analytical approaches and results to colleagues and stakeholders.Work Environment This position is based in a pharmaceutical quality control analytical laboratory that supports large-scale GMP manufacturing. The role is part of a newly formed team of approximately seven individuals within a broader QC analytical organization of more than eighty team members. The team includes a supervisor and multiple scientists who collaborate closely on testing priorities and method execution. The laboratory environment is bench-based, with routine use of analytical instruments such as spectrometers, plate readers, HPLC/UPLC systems, and other bioanalytical equipment. New team members receive an extensive training period of approximately 3–6 months, with structured qualification on each test method before progressing to the next, ensuring confidence and competence in all assigned techniques. The culture emphasizes continual learning, professional growth, and empowerment, supported by substantial investment in research, development, and laboratory resources. Work is performed in a regulated, safety-conscious setting that follows cGMP, SOPs, and laboratory safety practices, with appropriate laboratory attire and personal protective equipment required. Job Type & Location This is a Contract to Hire position based out of Berkeley, MO. Pay and Benefits The pay range for this position is $30.00 - $38.46/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program • Hiring diverse talent, • Maintaining an inclusive environment through persistent self-reflection, • Building a culture of care, engagement, and recognition with clear outcomes Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.