Director of Land Surveying
True Environmental
Senior Director, Analytical Sciences
Amicus Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Princeton • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $250,000 - $280,000 per year
Job Level
Senior
About the role
- Lead the development and execution of CMC analytical strategies for large- and small-molecule programs
- Oversee analytical method development, validation, and characterization testing for clinical and commercial products
- Provide subject matter expertise for large molecules and support investigations and regulatory information requests
- Collaborate cross-functionally with Tech Ops, Quality, CMC Regulatory Affairs, and Global Regulatory Affairs to drive program execution
- Oversee outsourced analytical packages and partner with CDMOs to ensure scientific rigor and regulatory compliance
- Partner with QC to implement continuous improvement initiatives and ensure timely project progression
- Provide strategic oversight of analytical content for regulatory submissions and represent Analytical Sciences on the CMC Leadership Team
- Lead, manage, and develop a team of 3–5 direct reports
- Engage with external industry organizations and consortia to benchmark best practices
Requirements
- Advanced Degree in Analytical Chemistry or Related (Ph.D. preferred)
- M.S. with 15+ years experience in large molecules considered
- Over 10 years of hands-on experience in large molecule analytical development and validation
- Understanding of small molecule analytics (preferred)
- Experience supporting global regulatory submissions across the lifecycle for large & small molecules
- Experience working in an external development business model with strategic CDMO partners
- Subject matter expertise in large molecules, analytical method development and validation
- Experience with analytical characterization testing for clinical and commercial programs
- Proven leadership experience managing and developing teams (3–5 members)
- Strong problem-solving, writing, negotiation, and influencing skills
- Exceptional communication skills for senior stakeholder engagement
- Passion for rare disease and patient-focused mindset
- Willingness to travel ~10%
Benefits
- Health insurance
- Retirement plan (401K)
- Paid time off
- Performance-based bonuses
- Stock options
- Restricted stock units
- Other discretionary awards
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
analytical method developmentanalytical validationanalytical characterization testinglarge molecule analyticssmall molecule analyticsregulatory submissionsCDMO partnershipscontinuous improvement initiativesproject managementteam leadership
Soft skills
problem-solvingwritingnegotiationinfluencingcommunicationstakeholder engagementteam developmentstrategic oversightcollaborationpassion for patient-focused mindset
Certifications
Ph.D. in Analytical ChemistryM.S. in Analytical Chemistry or Related
