Staff Scientist – Process Validation & Technology Transfer

Job Summary

Required Qualifications

• •B.S. in Chemistry, Biochemistry, Chemical or Biochemical Engineering, or a related field
• •8+ years of industry experience
• •M.S. with 6+ years
• •Ph.D. with 4+ years
• •Experience in process validation in a cGMP biologics or cell and gene therapy environment
• •At least 2 years in a technical leadership or program-lead capacity
• •CDMO experience
• •Demonstrated expertise in process validation and CPV program development
• •Deep understanding of biologics and viral vector (AAV, lentiviral) manufacturing processes across upstream, downstream, and drug product, including single-use technologies and aseptic fill/finish
• •Strong working knowledge of FDA, EMA, and ICH guidance and cGMP requirements, including FDA Process Validation guidance, ICH Q8–Q11, EU GMP Annex 1, and applicable cell and gene therapy guidance
• •Expertise in lifecycle process validation (Stage 1–3), CPV, and control strategy development
• •Working proficiency in statistical methods and tools used for validation and CPV — sampling plan justification, capability indices, control charting, and trending in JMP, Minitab, or equivalent
• •Executive-level written and verbal communication skills
• •Outstanding ability to analyze, interpret, and synthesize data; define problems; establish facts; draw valid conclusions; and make decisions
• •Excellent troubleshooting skills with the ability to resolve complex technical issues
• •Ability to apply Good Manufacturing Practice (GMP) principles and knowledge of pharmaceutical processes, equipment, instrumentation, and procedures
• •Presence on the manufacturing floor with strict adherence to GMP cleanroom guidelines
• •Occasional travel to other Thermo Fisher sites or client locations

Desired Qualifications

• •Work Schedule Standard (Mon-Fri)
• •Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Standing for full shift
• •Provide technical and organizational leadership for Process Validation (PV), Continued Process Verification (CPV), technology transfer, and lifecycle management
• •Own validation strategy execution, regulatory compliance, documentation readiness, and operational support for both clinical and commercial programs
• •Partner cross-functionally with Manufacturing, Quality, Engineering, Regulatory, and Supply Chain to drive compliant, efficient, and scalable process validation and documentation practices
• •Establish and maintain site SOPs, policies, and standards aligned with global procedures and regulatory requirements
• •Provide technical oversight for validation impact assessments and risk-based process decisions
• •Author, execute, and approve validation deliverables including Stage 1 process characterization and control strategy documents, PPQ protocols and reports, hold-time and mixing studies, aseptic process simulations, and shipping validation
• •Partner with Process Engineering and Manufacturing to support deviation investigations, change controls, and lifecycle management activities
• •Support regulatory submissions and responses through technical documentation review and validation justification
• •Serve as technology transfer lead for programs moving from internal process development or client sites into GMP manufacturing
• •Manage validation documentation timelines to ensure on-time delivery aligned with program milestones
• •Collaborate cross-functionally and with clients to align on validation strategy and technical direction
• •Manage multiple concurrent program lifecycles and ensure prioritization aligned with business objectives
• •Communicate technical risks, mitigation strategies, and performance metrics to senior leadership and client
• •Lead initiatives to enhance validation efficiency, reduce documentation cycle times, and improve CPV data visibility