Quality Control (QC) Associate Scientist
GenScript/ProBio
Summary
We are seeking a detail-oriented and proactive Associate Scientist to join our Protein Department QC group. This role is responsible for performing analytical characterization and quality control testing of recombinant proteins generated from high-throughput production workflows. The successful candidate will play a critical role in ensuring protein identity, purity, and overall quality through robust analytical methodologies.
Job description
Key Responsibilities
- Perform routine and non-routine analytical and QC testing to evaluate protein identity, purity, and quality attributes.
- Execute a range of protein characterization assays, including HPLC/UPLC (SEC, RP, IEX), Capillary Electrophoresis (CE, iCE/cIEF), SDS-PAGE, Western blot, LC-MS, and endotoxin assays.
- Prepare samples, reagents, buffers, and standards in accordance with established protocols and assay requirements.
- Perform sample preparation workflows, including use of automated liquid handling systems where applicable.
- Analyze, interpret, and document experimental data in ELN, LIMS, or equivalent systems, ensuring compliance with data integrity standards (e.g., ALCOA+ principles).
- Support method troubleshooting and optimization, ensuring assay robustness, reproducibility, and consistency across runs.
- Maintain laboratory instruments and ensure proper calibration and performance, supporting compliance with quality and safety standards.
- Collaborate with cross-functional teams (e.g., protein production, process development) to support project timelines and deliverables.
- Contribute to continuous improvement initiatives, including method refinement, workflow efficiency, and data quality enhancement.
Qualifications
- BS or MS in Biochemistry, Analytical Chemistry, Biotechnology, or a related field with 2+ years of relevant experience in protein analytical characterization or QC.
- Hands-on experience with protein analytical techniques such as HPLC/UPLC, CE, SDS-PAGE, Western blot, LC-MS, or endotoxin assays.
- Familiarity with protein characterization workflows, including purity, aggregation, and identity analysis.
- Experience with laboratory data systems (ELN, LIMS, or similar) and strong documentation practices.
- Strong attention to detail and commitment to data integrity, accuracy, and reproducibility.
- Experience in a CRO/CDMO or regulated QC environment is preferred.
Requirements
- BS or MS in Biochemistry, Analytical Chemistry, Biotechnology, or a related field
- 2+ years of relevant experience in protein analytical characterization or QC
- Hands-on experience with protein analytical techniques such as HPLC/UPLC, CE, SDS-PAGE, Western blot, LC-MS, or endotoxin assays
- Familiarity with protein characterization workflows, including purity, aggregation, and identity analysis
- Experience with laboratory data systems (ELN, LIMS, or similar) and strong documentation practices
- Strong attention to detail and commitment to data integrity, accuracy, and reproducibility
- Experience in a CRO/CDMO or regulated QC environment is preferred
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Parental Leave
- Paid Time Off
- Flexible Spending Account
- Health Savings Account
- Life & AD&D Insurance
- Short & Long-Term Disability
- Legal Assistance
- Pet Insurance
- Critical Illness Insurance
- Accident Insurance
- Hospital Indemnity Insurance
- Commuter Benefits
Company overview
GenScript ProBio is a global contract development and manufacturing organization (CDMO) specializing in advanced therapies, operating as a subsidiary of GenScript Biotech Corporation. Founded in 2020 and headquartered in Pennington, New Jersey, the company provides end-to-end CDMO services from drug discovery to commercialization, with a particular focus on cell and gene therapies, biologics, and recombinant protein drugs. ProBio's comprehensive service portfolio includes plasmid DNA manufacturing, viral vector production (AAV and lentiviral platforms), antibody discovery, mRNA vaccines, and antibody-drug conjugates. The company operates state-of-the-art GMP facilities, including a flagship 128,000 sq ft Cell and Gene Therapy Center of Excellence in Hopewell, New Jersey, which supports clinical-stage development and manufacturing. With expertise spanning CGT, antibody development, and protein therapeutics, ProBio aims to accelerate drug development timelines for biopharmaceutical innovators through proactive strategies, professional solutions, and efficient processes. The company has supported over 135 IND programs globally and employs advanced technologies to streamline therapeutic development from concept to clinic.