Associate Director, CMC, Analytical Development

• Develop analytical methodologies and perform characterization activities for new drug substance and drug product development and manufacturing
• Provide guidance and support to internal and external groups to ensure regulatory and corporate-policy compliance, including GLP and cGMP
• Provide analytical support for preclinical, clinical, registrational, validation, and commercial batches
• Design and execute phase-appropriate analytical strategies with cross-functional project teams
• Manage analytical method development, optimization, troubleshooting, qualification, and validation for starting materials, process intermediates, drug substances, and drug products
• Identify and recommend analytical methodologies for chemical development, formulation development, QC, and stability testing
• Manage CRO/CDMO analytical activities, including method development, qualification/validation, transfer, and characterization testing
• Review analytical raw data packages and ensure GLP/cGMP compliance
• Resolve technical issues and review deviations, failure investigations, OOS, and OOT investigations
• Collaborate with Quality Control and Quality Assurance for timely GMP release of drug substance and drug product lots
• Author and review technical documents covering validation, transfer, reference standards, impurity characterization, and stability
• Author and review analytical sections of CMC regulatory submissions
• Represent Analytical Development in CMC teams and interdepartmental meetings
• Maintain current knowledge of drug-development issues, Competent Authority regulations, guidance, and industry trends
• Follow company policies and ensure direct reports follow them, if applicable
• Travel domestically and internationally up to 25%
• Perform other duties as assigned

• Ph.D. or M. Sc. in analytical chemistry or a closely-related field
• 10+ years of directly-related industry experience
• Experience with analytical development of small molecules and solid oral dosage forms from preclinical through Phase 3
• Extensive analytical method development, troubleshooting, and validation experience
• In-depth experience with HPLC, GC, dissolution, compendial methods, impurity and degradation-product identification, and reference standard qualification
• Knowledge of drug development, CDMO management, manufacturing, and regulatory CMC
• Extensive knowledge of cGMP-related regulations, guidance, principles, and best practices for drug substances and drug products
• Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
• Experience preparing and updating IND, IMPD, CTA, NDA, and MAA regulatory filings
• Experience managing projects and FTEs at GMP testing CROs
• Ability to organize and prioritize tasks to meet deadlines
• Ability to multitask and adapt to changing business requirements
• Proven problem-solving skills
• Excellent oral and written communication, leadership, and interpersonal skills
• Ability to travel up to 25% domestically and internationally
• Ability to work onsite at the Boston office a minimum of two days per week

Demonstrates extensive expertise in analytical method development, validation, and troubleshooting for drug substances and products, with a strong focus on compliance with cGMP and GLP regulations. Proven ability to manage cross-functional teams and projects while ensuring timely regulatory submissions and adherence to industry standards.

• Analytical Method Development
• HPLC and GC Expertise
• Regulatory CMC Knowledge
• Project Management in GMP Environments
• Leadership and Communication Skills

• Analytical Method Development
• Validation and Qualification
• HPLC
• GC
• Dissolution Testing
• Compendial Methods
• Impurity Identification
• Degradation-Product Identification
• Reference Standard Qualification
• Regulatory Filing Preparation

• Problem-Solving Skills
• Organizational Skills
• Interpersonal Skills
• Leadership Skills
• Adaptability

• CGMP
• GLP
• Drug Development
• CDMO Management
• IND
• IMPD
• CTA
• NDA
• MAA
• Quality Control