Senior Scientist, Analytical Development
AI Summary
Leads analytical method development and optimization for biologics and vaccine programs, designs and executes complex assays, troubleshoots instrumentation and assay issues, mentors junior scientists, and ensures documentation and compliance readiness.
About this role
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Summary:
Vaxcyte has an exciting opportunity for an energetic and talented individual to join our Analytical Development team. The Senior Scientist, Analytical Development, is responsible for leading analytical method development activities for biologics/vaccine development programs. This role designs and drives method development, performs and oversees routine and non-routine analytical assays using modern analytical techniques, and leads method optimization, troubleshooting, and continuous improvement initiatives with minimal supervision, including mentoring and technical guidance to junior team members. The position requires demonstrated hands-on laboratory experience, deep technical expertise, and strong problem-solving skills, with the ability to independently plan and execute work, interpret complex data, and drive investigations to root cause and resolution. This role also authors, reviews, and maintains high-quality technical documentation, including method protocols, method development reports, qualification documentation, SOPs, and clear technical summaries that communicate experimental findings and conclusions to internal and external stakeholders.
Essential Functions:
Method Development & Troubleshooting
- Provide technical leadership and strategic direction for method development, optimization and qualification/validation readiness.
- Define development strategies and experimental roadmaps, identify critical method attributes, set robustness/qualification approaches, and drive alignment with program and regulatory expectations.
- Lead complex troubleshooting and investigations across assays and instrumentation; establish root-cause and preventive controls, and mentor others in problem-solving.
- Lead authorship and review of methods, SOPs, protocols, and technical reports; set documentation standards and ensure consistency and readiness for audits/inspections.
Team Collaboration
- Serve as a cross-functional technical leader, aligning analytical strategy with program objectives and driving execution against key milestones and deliverables.
- Proactively identify, communicate, and manage technical risks and resourcing constraints, influence decision-making with clear options, tradeoffs, and recommendations.
- Champion a culture of scientific excellence, compliance, and continuous improvement; establish best practices and drive adoption across the team.
- Lead capability building through mentoring, training programs, and coaching; develop team members’ technical depth, problem-solving, and communication skills.
Laboratory Operations & Instrumentation
- Promote efficient, compliant laboratory operations, including organization, cleanliness, and material control, aligned with applicable quality expectations.
- Provide oversight and prioritization for instrument maintenance, qualification, and service activities; serve as a technical point of contact for Lab operation team and vendor interactions and complex instrument issues.
- Ensure continuity of lab readiness by overseeing inventory strategy for reagents, standards, and consumables; support budgeting/forecasting and drive improvements to procurement and inventory processes.
Analytical Testing & Data Generation
- Lead routine and non-routine analytical testing using modern analytical methods (e.g., HPLC/UPLC, SEC, CE, UV-Vis, ELISA, electrophoresis, plate-based assays, and other biochemical or biophysical techniques).
- Maintain accurate and timely documentation in laboratory notebooks or electronic systems.
- Perform data processing and interpretation; draw conclusions, and clearly communicate outcomes, risks and recommendations to program and cross-functional stakeholders.
Safety & Compliance
- Follow all Environmental Health & Safety (EHS) policies and laboratory safety practices.
- Handle chemicals and biological materials safely and in compliance with regulatory requirements.
- Ensure proper waste disposal and adherence to hazardous material handling procedures.
- Support audit and inspection readiness activities where applicable.
Requirements:
PhD, MS or Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline. PhD with 5+ years; MS with 8+ years; BS with 10+ years of relevant industry experience in analytical development, QC, or related field. Other combinations of education and/or experience may be considered.
- Extensive hands-on experience across a broad analytical technique, such as UV-Vis, HPLC, CE, SDS-PAGE, icIEF, Liquid chromatography, Mass Spectrometry, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, and PCR.
- Experience leading method development or optimization activities preferred.
- Deep expertise in analytical chemistry/biochemistry with broad understanding across platforms.
- Recognized technical leader in troubleshooting complex, cross-cutting assay/instrument/system issues; drives investigations to root cause and establishes preventive controls.
- Advanced capability in data analysis and interpretation, including method performance characterization, statistical evaluation, and automation/standardization of data workflows where appropriate.
- Exemplary quality mindset and documentation rigor; authors/sets standards for methods, protocols, reports, and ensures audit/inspection readiness.
- Demonstrated ability to lead multiple priorities and influence program direction; effectively resource-plans, remove blockers, and mentor others to deliver results.
- Excellent communication skills: effectively communicate risk, options, and recommendations to stakeholders and leadership, and align cross-functional teams on path forward.
- Ability to work in a laboratory environment for extended periods.
- Ability to lift up to 25 lbs.
- Use of personal protective equipment (PPE) required.
- Contribute to a positive, inclusive, and safety-focused laboratory culture
Equal Opportunity
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
Recruitment Fraud Notice
Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.
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