Senior / Executive Director of Chemistry, Manufacturing, and Controls (CMC)
Benefits:
Competitive Pay
Stock Option Eligibility
401(k) Plan
Open PTO Policy
Health Care Plan, including Medical, Dental, and Vision, fully covered for the employees
Education Requirements:
PhD in Synthetic Organic chemistry, Chemical Engineering, Analytical chemistry, Pharmaceuticals or closely related scientific discipline
MS in Synthetic Organic chemistry, Chemical Engineering, Analytical chemistry, Pharmaceuticals or closely related scientific disciplines
Experience Requirements:
At least 12 years of industrial CMC experience with a PhD OR at least 16 years of industrial CMC experience with an MS
Proven success leading Analytical Development and QC activities through external CDMOs
Extensive hands-on experience in method development, transfer, troubleshooting, and validation for small molecule drug substance (DS) and drug product (DP)
Demonstrated history of successfully authoring and defending high-quality CMC sections for regulatory filings
Other Requirements:
Deep technical competence across API synthetic pathway optimization and modern drug product formulation methods for oral solid dosages
In-depth knowledge of cGMP laboratory operations, global regulatory expectations and relevant ICH guidance
Executive presence, negotiation capabilities, and strong communication skills
Motivated team player with strong critical thinking skills
Responsibilities:
Establish and execute the global CMC strategy for the small molecule discovery and development pipeline
Oversee phase-appropriate process chemistry, route scouting, crystalline form screening/polymorph evaluation, and scale-up strategies for critical active pharmaceutical ingredients (APIs)
Lead preformulation characterization and formulation development, focusing on maximizing bioavailability for challenging architectures
Oversee DS and DP analytical strategy and scientific oversight across characterization, impurity control, reference standards, comparability, stability, and QC testing
Source, select, contract, and direct global Contract Development and Manufacturing Organizations (CDMOs)
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