Senior Scientist - Analytical Development and Transfer
About The Position
The Senior Scientist - Analytical Development and Transfer is responsible for providing scientific leadership for analytical technology transfers across the CMC portfolio. This role drives analytical transfer strategy, governance, and execution to ensure successful delivery of site readiness activities, transfer milestones, and compliant analytical methods across internal laboratories, manufacturing sites, and external partners. The position contributes to the development of robust, sustainable, and inspection-ready analytical control strategies by establishing and overseeing transfer, validation, and verification activities. The individual serves as a technical authority for analytical transfers, supports regulatory and compliance objectives, and partners across functions to ensure high standards of quality, reliability, and operational excellence.
Requirements
- Fully adept in Good Manufacturing Practices (GMP) and GxP environments.
- Demonstrated success in GMP/QC-facing settings with a strong inspection readiness and data integrity (ALCOA+) mindset.
- Advanced understanding of analytical method transfer, co-validation, and verification activities.
- Experience leading end-to-end method transfers and/or co-validations across sites and CMOs (strategy, protocols, acceptance criteria, training, execution oversight, and final reports).
- Expert knowledge of risk-based validation and verification principles, including ICH guidance.
- Strong understanding of ICH expectations and the ability to execute risk-based validations
- Advanced proficiency in analytical techniques, including HPLC and related methodologies.
- Advanced writing and documentation skills for protocols, reports, and regulatory documentation.
- Advanced ability to apply innovation and continuous improvement principles.
- Strong knowledge of analytical development across the product lifecycle.
- Experience supporting regulatory submissions and inspection readiness activities.
- Excellent stakeholder management and communication skills.
Responsibilities
- Develop and execute analytical technology transfer strategies across multiple programs, ensuring successful delivery of transfer milestones, site readiness activities, and lifecycle management objectives.
- Lead or influence complex analytical transfer programs, providing scientific and strategic guidance across internal laboratories, manufacturing sites, and external analytical partners.
- Establish, govern, and continuously improve transfer documentation, including protocols, validation and verification plans, acceptance criteria, risk assessments, templates, and best practices.
- Manage key analytical vendor and contract laboratory relationships, including performance monitoring, governance reviews, escalation management, and accountable delivery of transfer commitments.
- Serve as a technical authority and escalation point for complex analytical issues, method performance challenges, investigations, deviations, and risk assessments, driving scientifically sound solutions and corrective actions.
- Partner with Analytical Development, Quality Assurance, Quality Control, Manufacturing, MSAT, Regulatory CMC, Supply Chain, and other stakeholders to align priorities, resolve issues, and deliver business objectives.
- Contribute significantly to departmental scientific strategy and operational excellence initiatives by establishing scalable ways of working, governance models, and knowledge-sharing frameworks.
- Identify improvement opportunities and lead local and global initiatives focused on analytical transfer excellence, inspection readiness, network performance, and right-first-time execution.
- Mentor and develop scientific staff through coaching, technical review, training programs, and adoption of analytical transfer standards and best practices.
- May have direct reports.
Benefits
- medical, dental, vision insurance
- a 401(k) plan and company match
- short-term and long-term disability coverage
- basic life insurance
- a tuition reimbursement program
- paid volunteer time off
- company holidays
- well-being benefits
- up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
