Bioassay Specialist

BioSpace is partnering with an early-stage biopharmaceutical company whose focus is on the discovery and development of novel immunomedicines for the treatment of cancer and other immune-related diseases. Those with strong backgrounds in cell-based Nab, potency, and functional assays are encouraged to apply.

Duties

• Leverage strong understanding and knowledge of mechanism of action (MOA) for cell-based potency assay development and optimization:
• Poses expertise in developing functional cell-based assays for use in evaluating the relative potency of drug substance and drug product and/or the neutralizing capability of confirmed binding anti-drug antibodies in serum
• Independently design, develop, optimize, qualify and/or validate and transfer novel cell-based bioassays and immunoassays for relative potency and neutralizing anti-drug antibody endpoints
• Draft and review SOPs, technical reports, and regulatory documents
• Represent the Cell-based Bioanalytical Sciences function as a team representative at team meetings
• Experience working in a regulated industry setting as a GXP contributing scientist
• Extensive hands-on experience with the design, development, optimization, qualification and validation of novel bioassays and immunoassays across multiple platforms and technologies (e.g, ELISA, MSD, flow cytometry and cell based - proliferation, phosphorylation, reporter and cytotoxicity assays)
• Perform Cell line development and characterization, cell culture and cell banking.
• Extensive experience passaging, transfection, clonal selection, mass production, and cryo banking
• Knowledge of GxP as relevant to laboratory practices in sample handling and analysis of GLP, GCP, and/or GMP samples and specimens
• Knowledge of industry guidance’s for the development, qualification/ validation of functional cell-based assays, GMP Potency methods, and/or neutralizing antibody assays
• High competence in common software and data analysis packages (e.g., SoftMax Pro, GraphPad Prism, JMP, Microsoft Office tools)
• Lead internal discussions regarding bioanalytical assays, author technical reports, author INDs sections, author SOPs, present scientific data at meetings, build and maintain a culture of responsibility and accountability
• Contribute to increasing assay development throughput through systems, processes, equipment, automation, management, etc.
• 80% Hands on laboratory work.
• Provide general operational support.

Required Education, Experience, & Qualifications

• PhD with 2+ years' experience, Master’s Degree with 4+ years' experience, or Bachelor’s Degree with 8+ years' experience in related scientific discipline
• Pharmaceutical (large molecule), biotechnology, or CRO experience is required
• Cell-based potency, NAb, and functional assay development and validation
• GMP and GLP/GcLP experience is preferred
• Proficient in developing, troubleshooting, and validating (according to regulatory requirements)
• Experience working in a GLP/GcLP environment is highly desirable.
• Proven problem-solving ability
• Ability to operate and maintain laboratory equipment with independence.
• Excellent written and verbal communication skills and ability to draft technical reports.
• Outstanding project management and organizational skills and ability to multitask and perform in a fast-paced entrepreneurial and growing environment
• Solid interpersonal skills and ability to work in matrix team environment
• Demonstrated understanding of the biotech/pharma industry and therapeutic product development
• Passionate about scientific innovation, self-starter, goal-driven, and strive to continuously build knowledge and skills for personal, professional and organizational growth