Technical Director managing technology delivery, operations, and innovation across APAC at IDEMIA. Ensuring client infrastructure and systems are implemented and managed to the highest standards.
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
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