Director, Analytical Development
$211,000–$257,000 year
On-siteWaltham, Massachusetts, United States
Job Summary
Develop and lead execution of analytical strategies for commercial drug substance and product, preparing RFPs and managing partner selection under cGMP requirements. Establish resource plans and operational budgets to support corporate objectives while integrating Commercial Analytical activities with CMC, Quality, Manufacturing, and Regulatory functions. Lead preparation of regulatory documents for NDAs and represent the function in interactions with regulatory authorities and external steering teams. Evaluate analytical risks and propose lifecycle strategies to senior leadership. This role requires periodic travel to manufacturing and partner sites (10-20% of time) and involves close collaboration with technical, legal, finance, and supply chain functions in a cGMP environment.
Required Qualifications
- Bachelor's Degree
- 10+ years of industry experience
- Strong experience in analytical chemistry
- Strong experience in associated regulatory requirements
- Experience working in close collaboration with technical, regulatory, quality assurance, project management, legal, finance, and supply chain functions
- Experience in leading and managing outsourced analytical activities
- Experience in associated operating budgets
- Experience in preparing and defending regulatory documents
- Excellent communication skills
- Ability to present to diverse internal and external audiences
- Periodic travel to manufacturing and other partner sites
- Periodic travel to manufacturing and other partner sites (approximately 10-20 % of time)
Desired Qualifications
- Advanced degree
- Experience in a cGMP operational environment
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