(Sr) Associate Scientist, Analytical Development

Responsibilities include, but are not limited to:

• Perform laboratory experiments independently following established protocols to support inter-departmental teams, analytical method development, qualification, transfer, and product characterization.
• Independently culture, maintain, expand, and cryopreserve cell lines in accordance with established protocols and quality standards. Maintain cell banks and accurately document passage history and inventory records.
• Perform cell-based cytotoxicity, molecular biology, and immunoassays to support product release, characterization, development, stability, and forced degradation studies, including DNA/RNA extraction, qPCR quantification, ELISA, and Gel electrophoresis (SDS-PAGE, Western blotting).
• Collaborate effectively with cross-functional teams to meet project timelines.
• Identify, investigate, and resolve technical challenges, experimental deviations, and assay performance issues as needed. Communicate findings to appropriate scientific team members.
• Serve as a subject domain lead for assigned techniques to identify atypical trends and providing technical guidance, as applicable
• Operate, maintain, and troubleshoot routine laboratory instruments used for molecular biology, bioassay, and analytical testing.
• Maintain accurate, timely, and compliant records in electronic laboratory notebooks in accordance with good documentation practices and data-integrity requirements.
• Prepare and review technical documentation, including data packets, standard operating procedures, test methods, and method development reports.
• Participate in data review and scientific discussions related to analytical development and product characterization studies and present experimental results and scientific findings to internal and external stakeholders, as appropriate.

• Bachelor’s degree in Molecular Biology, Cell Biology, Biochemistry, Biotechnology, Chemistry, Chemical Engineering, or a related scientific discipline.
• 2-4 years of relevant laboratory experience demonstrating hands-on experience with molecular biology techniques, including DNA/RNA extraction, nucleic acid quantification, PCR or qPCR, and agarose gel electrophoresis.
• Experience in aseptic techniques is required with proven experience in regular cell maintenance techniques. And performance of cell-based cytotoxicity assays.
• Motivation to learn and grow and ability for problem solving is highly desirable.
• Demonstrated ability to independently execute, document, analyze, and troubleshoot electrophoresis and qPCR experiments.

• Experience with one or more additional analytical techniques, such as SDS-PAGE, Western blotting, capillary electrophoresis, ELISA, UV/Vis spectroscopy, or HPLC/UPLC is preferred.
• Understanding of analytical method development, qualification, validation, and technology transfer principles.
• Experience working in a regulated laboratory environment and applying good documentation and data-integrity practices.
• Experience supporting the analytical development or characterization of biologics, including drug substance and drug product.
• Familiarity with scientific data analysis, graphing software, and basic statistical concepts.
• Some travelling maybe required to assist with assay establishment, troubleshooting at CDMOs

• Ability to follow detailed protocols, prepare reagents and samples accurately, and independently troubleshoot routine experimental and instrument-related issues.
• Strong attention to detail, scientific curiosity, and problem-solving ability.
• Ability to manage multiple assignments, prioritize laboratory activities, and meet established timelines.
• Effective written and verbal communication skills.
• Ability to work independently while collaborating effectively within cross-functional teams.

Salary Range: $70,000/yr - $115,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

Health insurance with FULL premium coverage

401K with company match

Competitive paid time off (PTO)

Company-paid short & long-term disability insurance and life insurance