Subject matter expert for impurity characterization. Track and evaluate impurity profiles for drug substance and drug product. Characterize and identify unknown impurities and their mechanism of formation. Develop new methods for impurity tracking.
Identify and recommend analytical methodologies to support chemical development, formulation development, QC and stability testing.
Work with multi-functional project teams to design and execute phase-appropriate analytical strategies including analytical method development and qualification/validation as well as product characterization.
Lead and perform activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products produced internally and at CMOs.
Resolve technical issues, review deviation events and failure investigations at contractor sites in coordination with internal and external quality control, quality assurance, and regulatory groups, as appropriate. Provide SME technical input for OOS and OOT investigations.
Author/review technical documents outlining analytical activities including method validation, reference standard and impurity characterization, stability, etc.
Author/review analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions.
Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development
Represent analytical function in CMC teams and interdepartmental meetings
What is Required
Doctoral (Ph.D.) degree in Analytical Chemistry, Organic Chemistry or related discipline plus 8+ years of relevant industrial experience, or Masters (M.S.) +10 years or BS +15 years or more years' experience
Demonstrated expertise in the identification of impurities (process impurities, degradation products, genotoxic impurities, etc). Expertise in LC/MS and NMR analysis and interpretation. Extensive hands-on experience with mass spectrometry (QTOF, triple quadrupole) and NMR, specifically for impurity identification.
In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc), and reference standard qualification.
Experience with analytical development (both drug substance and drug products) of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3)
Extensive hands-on analytical method development, troubleshooting, investigation and validation experience
Demonstrated knowledge of drug development, CMO management, manufacturing, and regulatory CMC for development and commercial stage programs
Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
Experience preparing and updating regulatory filings (IND, NDA, MAA)
Outstanding written and verbal communication skills
Ability to effectively organize and prioritize tasks to achieve established deadlines
Ability to multi-task and adapt rapidly to changing business requirements in a dynamic corporate environment.
Proven problem-solving skills are a must
Ability to travel up to 10% domestically and internationally