We are looking for an experienced and motivated Senior Scientist to join us as a member our Development team. In this role you be responsible for effective planning, execution and coordination of assay and reagent development efforts to ensure the successful delivery of products with the highest quality, safety, and effectiveness.

Candidates for this position must enjoy working for a fast-paced, cutting-edge company and demonstrate exemplary team capabilities and a passion for contributing to our life-saving mission.

Responsibilities:

• Responsible for assay and reagent development within a design-controlled organization during development, verification, validation, and commercial launch
• Responsible for drafting and managing execution of verification and validation studies
• Independently design and execute novel immune-PCR based experiments for improved assay function, robustness, and QC method development
• Lead and execute design of experiments (DOE) for assay optimization and guard-banding
• Lead and execute the automation of bench procedures on liquid handling platforms
• Accountable for data and root cause analysis during product development lifecycle
• Establish development project plans to meet milestones based on company goals
• Author design-controlled documentation during product development
• Work as a key member within a cross functional team to identify improved methods, workflows, and reagent manufacturing processes
• Maintain accurate records of experiments in line with quality requirements
• Collaborate and communicate within a matrixed cross functional environment including status updates to broader team
• Present data at external scientific meetings, proactively publish and patent

 

Requirements:

• BSc/MS life science degree + 8 years’ industry experience or PhD + 3 years’ industry experience
• Minimum 3+ years of laboratory experience in assay or product development in a biotech or pharma setting is required
• Experience with late-stage assay development including verification and validation studies for an FDA approved product is required
• Proficiency with standard bioanalytical and molecular biology techniques including ELISA, qPCR, absorbance spectroscopy, pH and conductivity
• Previous experience with protein bioconjugation techniques and familiarity with bioconjugate purification methods is strongly preferred
• The ability to follow established controlled documentation with strict attention to detail
• Proficiency in collecting and accurately documenting experimental procedures and results is essential. Familiarity with electronic lab notebook (ELN) or laboratory information management systems (LIMS) is strongly preferred
• The ability to work effectively and efficiently with other team members in a fast-paced and dynamic environment is essential
• Experience with DOE software such as JMP or Minitab is strongly preferred
• Proficiency in software applications like PRISM, Microsoft Word, Excel, and PowerPoint is required

Posted On: Tuesday, January 7, 2025