Senior Scientist – Analytical Development

Senior Scientist – Analytical Development

Requirements

• Advanced degree (PhD) in immunology, cell biology, biomedical engineering, or equivalent. Technical training / certification desirable.
• 5-8 years of experience in method development of gene-modified products in analytical development and/or QC in a biotech, academic, or pharmaceutical setting.
• Expertise in analytical method development and qualification/validation is required.
• Experience in developing multicolor flow cytometry methods, cell culture including reporter gene cell line development, potency assays, cytotoxicity assays, cytokine release assays, immunoassays and/or molecular assays.
• Experience in method qualification/validation design and execution.
• Authoring SOPs/procedures for established methods.
• Ability to transfer of release methods to internal or external QC as appropriate.
• Participate in cross-functional project teams to advance products towards and through clinical trials.
• Stay current on the latest advancements in assay development and apply relevant knowledge to guide the analytical development activities.
• Knowledge and experience with viral vectors, gene editing analytics are a plus.
• Authored source documents and / or sections of regulatory submissions is a plus.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Excellent presentation skills and scientific/technical writing skills.
• Proficient in cGMP and ICH guidelines is preferred.
• Excellent teamwork, emotional intelligence, and communication skills.
• Composure during challenging times.
• Ability to work in a team environment.
• English and Mandarin are preferred.

Responsibilities

• Create and refine the method development, qualification, validation approaches for rapidly delivering phase-appropriate analytical components of projects with scientific excellence and patient-focus.
• Drive method development to meet established timeline while maintaining the highest quality and data integrity standards. Lead efforts in tech transfer of assays from R&D teams to advance assays towards GMP/QC operations and identify critical parameters within assays for qualification activities.
• Develop functional assays (e.g., cell-based), bioanalytical assays (e.g., ELISA) and/or molecular assays (e.g., ddPCR).
• Develop and optimize multi-color flow cytometry methods such as (but not limited to) phenotyping of T, B, NK and other cells of the immune system, proliferation assays, apoptosis assays, cell cycle analysis and intracellular staining assays.
• Ability to design, execute the development and qualification of release, characterization, and stability assays for testing of a clinical trial (first-in-human/new IND), and in support of product and process development.
• Establish and author SOPs/procedures for methods developed for use in QC release testing.
• Ability to work with analytical/QC staff in performing functional, bioanalytical and flow assays for product release and/or characterization.
• Author and review technical protocols, technical reports, and/or external scientific publications.
• Ability to maintain accurate and updated lab notebooks and QC records.
• Work within the team to manage equipment and records for maintenance, calibration and operation, and maintain laboratory inventories.
• Analyze data for trends and present analyzed data within and across departmental meetings.
• Subject Matter Expert (SME) in technology transfers to QC and execution in QC product-specific methods and /or to external partners and between sites. Lead method qualification activities.
• Provide analytical support as SME for manufacturing and QC root cause investigations for OOS/OOE.
• May participate in audits of 3rd party vendors as SME.
• Ability to work collaboratively within the Analytical Development team to establish the analytical control strategy of the established methods.

Preferred Qualifications

• Knowledge and experience with viral vectors, gene editing analytics are a plus.
• Authored source documents and / or sections of regulatory submissions is a plus.
• Proficient in cGMP and ICH guidelines is preferred.
• English and Mandarin are preferred.