Senior Scientist

About the Role:
The Senior Scientist Process Analytics Drug Substance is a key technical leadership role focused on analytical development process analytical technology and control strategy design within a clinical-stage biopharmaceutical environment. This position supports drug substance and drug product development driving analytical method lifecycle management process understanding and regulatory readiness. Common search terms for this role include Senior Scientist Process Analytics Analytical Development Scientist Drug Substance Scientist PAT Scientist and CMC Analytical Lead.

Responsibilities:

• Lead analytical and process analytical technology strategy translating process development needs into phase-appropriate analytical methods and control strategies
• Own the full lifecycle of drug substance analytical methods including development validation qualification and technology transfer to manufacturing partners
• Provide technical leadership for tech transfer activities to CDMOs including analytical comparability and method transfer documentation
• Develop and implement Quality by Design based control strategies including identification of critical process parameters and critical quality attributes
• Design and execute purification process development and optimization studies for drug substance manufacturing
• Perform statistical data analysis including design of experiments multivariate analysis and statistical process control to support process validation and continued process verification
• Generate analytical trend reports and support process performance qualification readiness
• Support manufacturing campaigns investigations and product quality events with data-driven insights
• Collaborate cross-functionally with drug product quality regulatory and external partners to ensure alignment on analytical strategies
• Author and review regulatory documentation including CMC sections and support health authority submissions and interactions
• Serve as a subject matter expert in analytical development and mentor junior scientists

Qualifications:

• PhD with 5 or more years MS with 8 or more years or BS with 10 or more years of experience in analytical development process analytics or biopharmaceutical development
• Strong expertise in analytical method development validation and lifecycle management in a cGMP environment
• Deep knowledge of Quality by Design principles including CPPs CQAs and control strategy development
• Experience with statistical tools such as design of experiments data trending and multivariate analysis
• Proven experience supporting technology transfer analytical comparability and manufacturing scale-up
• Strong understanding of regulatory expectations for CMC documentation and analytical methods
• Excellent problem-solving communication and cross-functional collaboration skills

Desired Qualifications:

• Experience with therapeutic peptides peptide API development or purification processes
• Hands-on experience with process analytical technology tools spectroscopy and real-time monitoring systems
• Experience authoring CMC sections and supporting regulatory submissions and health authority interactions
• Familiarity with ICH guidelines including Q1 Q2 Q8 through Q12 Q11 and current good manufacturing practices
• Experience supporting drug product stability programs and lifecycle management activities