QC Scientist II (Bioassay)
hace 2 días
Saint Louis
Job DescriptionJob Title: QC Scientist II (Bioassay) Job Description The QC Scientist II (Bioassay) supports GMP manufacturing by performing analytical testing for commercial product release, in-process control, and stability studies for large molecule biopharmaceuticals. You will apply a broad range of bioassay and compendial methods in a cGMP-regulated analytical laboratory, contribute to investigations and data review, and collaborate closely with cross-functional teams to ensure high-quality, reliable results. This position offers the opportunity to grow into a full-time role, develop advanced technical expertise, and contribute to meaningful work in a science-driven environment. Responsibilities • Perform ELISA and a wide range of compendial tests, including pH, UV, and osmolality measurements, as well as other routine and specialized analytical procedures on in-process, drug substance release, and stability samples to support project timelines., • Execute enzyme activity assays under defined temperature and incubation conditions, ensuring accurate preparation, execution, and documentation of all experiments., • Operate and maintain analytical instrumentation such as spectrometers, plate readers, SoloVPE, and other minor laboratory equipment in accordance with laboratory procedures., • Conduct colorimetric assays, including methods such as Picogreen and Bradford, and other color-based analytical techniques as required for large molecule analysis., • Perform GMP testing using HPLC and UPLC methods, including but not limited to reverse phase, size-exclusion chromatography (SEC), concentration assays, cation-exchange chromatography (CEX), and related techniques., • Compile, analyze, and interpret test data, and prepare clear and accurate documentation and reports in compliance with cGMP and internal quality standards., • Review laboratory data packets as assigned, ensuring data integrity, completeness, and compliance with applicable procedures and regulatory expectations., • Author and perform laboratory investigations as assigned, including out-of-specification (OOS), out-of-trend (OOT), invalid tests, and laboratory incidents, and contribute to root cause analysis and corrective actions., • Recognize and promptly report invalid results, laboratory incidents, out-of-specification results, and out-of-trend data to laboratory leadership, and recommend appropriate follow-up or corrective actions., • Collaborate with team members, quality assurance, and data reviewers to ensure alignment on testing priorities, resolution of issues, and continuous improvement of laboratory processes., • Contribute to the development and refinement of new concepts, techniques, and standards within the QC analytical laboratory to enhance efficiency, robustness, and scientific rigor., • Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, and applicable safety guidelines and regulations., • Participate in routine laboratory activities such as safety inspections, housekeeping, and ordering or managing laboratory supplies to maintain a safe and efficient work environment., • Apply strong organizational and planning skills to manage multiple testing assignments, meet deadlines, and support changing project needs in a fast-paced setting., • Demonstrate flexibility, attention to detail, and a positive, collaborative approach while working within a newly formed team in a larger QC organization.Essential Skills, • Bachelor’s degree in chemical pharmaceutical sciences, biology, chemistry, biotechnology, or a closely related scientific field., • Between 1 and 4 years of proven industry experience in a GMP-regulated environment, preferably in the pharmaceutical or biopharmaceutical sector., • Hands-on experience performing compendial testing, including pH measurement, UV spectroscopy, and osmolality testing for large molecule or related products., • Proficiency with enzyme activity assays, including setup under specified temperature and incubation conditions and accurate interpretation of results., • Practical experience operating spectrometers and plate readers for quantitative and qualitative analytical measurements., • Strong qualitative pipetting skills and good laboratory technique, including careful sample handling and preparation., • Experience conducting GMP testing in an analytical laboratory using HPLC and UPLC methods such as reverse phase, SEC, concentration assays, and CEX., • Demonstrated experience working under cGMP, including adherence to SOPs, documentation practices, and FDA or similar regulatory expectations., • Ability to compile data, document test procedures, and prepare clear, accurate, and compliant reports., • Capacity to recognize and escalate invalid results, laboratory incidents, OOS, and OOT data, and to participate in investigations., • Good organization and planning skills, with the ability to manage multiple tasks and shifting priorities., • High attention to detail and commitment to data integrity and quality., • Positive, collaborative demeanor and the ability to work effectively as part of a laboratory team., • Basic proficiency with MS Office and laboratory computer programs used for data analysis and documentation.Additional Skills & Qualifications, • Experience at the QC Scientist I or II level, with 1–3 years of industry experience for QC Scientist I roles and 2–4 years for QC Scientist II roles., • Familiarity with SoloVPE for concentration or related optical measurements., • Experience with qPCR for quantitative nucleic acid analysis., • Hands-on experience with colorimetric assays such as Picogreen and Bradford for concentration and quantitation of biomolecules., • Experience with well-plate and multi-channel pipetting techniques for high-throughput or plate-based assays., • Prior involvement in peer data review and verification of analytical results., • Experience conducting or supporting laboratory investigations, including OOS and OOT investigations, and documenting findings., • Prior use of EMPOWER chromatography software for data acquisition, processing, and reporting is preferred., • Background in quality control, wet chemistry, bioassay, and UV-Vis analytical techniques., • Knowledge of additional laboratory and data systems beyond EMPOWER, where applicable, to support efficient data management., • Demonstrated flexibility in adapting to new methods, instruments, and procedures in a dynamic laboratory environment., • Strong interpersonal skills and the ability to receive and act on feedback constructively., • Interest in ongoing professional development and the ability to articulate longer-term career goals in analytical sciences or quality control.Work Environment You will work in a pharmaceutical QC analytical laboratory within a larger team of more than 80 professionals, joining a newly formed group of approximately seven colleagues, including a supervisor and six team members. The role is bench-based and involves routine use of analytical instruments such as HPLC, UPLC, spectrometers, plate readers, and other laboratory equipment in a cGMP environment. New team members receive an intensive 3–6 month training period, with hands-on instruction and qualification on each test method before progressing to the next, ensuring you are fully prepared and confident in each technique. The culture emphasizes continual growth, learning, and empowerment, with access to substantial scientific resources and opportunities to make meaningful contributions. The environment is collaborative, detail-oriented, and safety-focused, with expectations for adherence to SOPs, good documentation practices, and laboratory safety procedures. Work is conducted in a typical laboratory setting that requires appropriate laboratory attire and personal protective equipment, and offers the potential to transition into a full-time role based on performance and business needs. 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.
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