Senior Scientist, Analytical Science – Technology

This is a fully remote position, open to applicants in Kentucky, +13 more states.

📋 Description

• Oversee all method transfers and validations at external CDMOs.

• Draft and evaluate protocols, analyze raw data, and produce reports.

• Assist in QC deliverables for cellular drug substance and drug product development during late-stage clinical development.

• Review outsourced GMP activities.

• Act as the Lead Subject Matter Expert (SME) for method validations, assay control establishment, and method bridging/USP equivalency testing.

• Create and sustain tools to track assay validity.

• Regularly evaluate assay validity and conduct investigations as necessary.

• Foster collaborative relationships with external CMOs, contract laboratories, and internal Analytical Development, CMC, and Quality Assurance teams.

• Independently identify and resolve technical issues.

• Prepare technical proposals and execute solutions.

• Escalate challenges to management as needed.

• Oversee test methods, SOPs, and QC analytical data to ensure compliance with cGMPs, pharmacopeial, and regulatory standards.

• Provide technical assistance for deviations and laboratory investigations.

• Assess proposed analytical change requests.

• Maintain adaptability as per phase requirements.

• Perform additional duties as assigned.

⛳️ Requirements

• Minimum of 5 years in Quality Control or a related field with a Master’s Degree, or a PhD with 2 years of relevant QC experience.

• At least 8 years of experience in Quality Control or a related area with a Bachelor’s Degree.

• Familiarity with method validations and USP method verification during late-stage clinical development.

• Strong understanding of cGMP regulations, pharmacopeial guidelines, and relevant EMA, FDA, and ICH standards as they pertain to QC testing for cell therapy and method validations.

• Experience in reviewing analytical test results and resolving technical issues related to various cell-based QC assays.

• Practical experience and comprehensive knowledge of Flow Cytometry.

• Skilled in data charting and trend analysis during studies.

• Proficient in using statistical analysis software; JMP is highly preferred.

• Ability to identify risks associated with method qualifications and validations, with a successful history of overcoming challenges.

• Proven expertise in managing the analytical method lifecycle, including test method approval, method verification, method validation, and method transfer.

• Established ability to interface with CDMOs.

• Capacity to quickly adjust to changing environments and situations while ensuring compliance with cGMP and regulatory standards.

• Strong collaborative skills across various organizational levels.

• Capability to manage assigned project deliverables effectively.

• Excellent written and verbal communication skills, with the ability to clearly and persuasively summarize scientific data.

• Quality-focused mindset with the ability to address compliance gaps.

• Advanced proficiency in MS Office applications.

• Ability to work both independently and collaboratively with team members.

• Willingness to travel up to 15%.

🏝️ Benefits

• Comprehensive health insurance for employees and their families.

• 401(k) matching program.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Generous Paid Time Off (PTO).

• Paid parking facilities.

• Subsidized commuter passes.

• Catered lunches in the office.

• Team-building events.

• Opportunities to engage in community projects.

• Competitive compensation packages.