Specialist, Quality Control

Here's What You'll Do

• Execute testing for analytical method validation and qualification, alongside routine testing of release, stability, and in-process samples, using cell-based potency assays, enzyme-linked immunosorbent assays (ELISA), and protein analysis.
• Execute QC molecular biology and bioassay methods, including qPCR, sequencing, and protein analysis, and support bioassay testing for raw materials, drug substance, and drug product.
• Lead method transfers and qualification activities in collaboration with Development groups, helping expand QC Bioassay laboratory capabilities and establish methods that support reliable cGMP testing.
• Lead special projects as a Bioassay subject matter expert (SME), bringing technical expertise to laboratory challenges.
• Serve as an interdepartmental liaison to Manufacturing, Quality Assurance, Development, and other relevant groups.
• Teach and train analysts on technical concepts and analytical methods, providing on-the-job training that builds understanding of laboratory procedures and assay execution.
• Write and revise standard operating procedures (SOPs), protocols, and reports, ensuring compliance with cGMP documentation requirements and applicable regulatory guidelines.
• Troubleshoot analytical methods, equipment, laboratory procedures, and assay performance, applying technical understanding to identify issues and support effective resolution.
• Review analytical data and perform assigned data analysis and trending to support understanding of assay performance and laboratory results.
• Own and manage quality records, including investigations, change controls, corrective and preventive actions (CAPAs), and ECs, ensuring that associated activities and documentation meet cGMP requirements.
• Establish and maintain a safe laboratory working environment, provide support during audits, and collaborate on continuous improvement initiatives.
• Explore opportunities to build familiarity with Generative AI tools for technical learning, knowledge sharing, and continuous improvement, subject to company approval and appropriate data protection, scientific oversight, and cGMP controls.
• Remain accountable for completing all mandatory training and assigned tasks, and perform additional duties as assigned.

Here's What You'll Need (Basic Qualifications)

• Education: BA/BS Degree
• Experience: STEM degree with minimum 5 years of experience in a cGMP laboratory, with hands-on experience in molecular biology, Cell based Assays and Protein Analysis.
• Specific Certifications or Training: None

Here's What You'll Bring to the Table (Preferred Qualifications)

• Method development/qualification experience with molecular biology, cell-based assays, or protein analysis methods.
• Trained in Aseptic techniques and general laboratory instrumentation (e.g. pH meters, balances, pipettes)
• Ability to prepare reagents, pipette small volumes, work in a Biological Safety Cabinet
• Experience with laboratory equipment calibration and maintenance.
• Ability to work effectively in a fast-paced, cross-functional matrix environment.
• Working knowledge and application of FDA, EU, ICH guidelines, and regulations.
• Experience providing technical training.
• Experience in technical writing.