Director, Analytical Development (In-House)

Role Summary

The Director, CMC Analytical will lead analytical development activities for small molecule therapeutics, acting as a subject matter expert to solve complex analytical challenges and support the company’s discovery and development efforts.

Responsibilities

• Establish, direct, and monitor implementation of CMC testing methodologies and specifications for raw materials, intermediates, excipients, APIs, and drug products, with a focus on oral dosage
• Lead analytical development activities of assigned projects and deliver business results for CMC Analytical
• Develop departmental processes to achieve department and corporate goals; focus on immediate and short-term strategic planning
• Collaborate with external CRO/CDMO partners to advance method development, qualification, transfer, and validation for API and DP
• Provide detailed review and approval for protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification
• Review and approve analytical methods, specifications, change controls, deviations, investigations, and out-of-specification reports
• Ensure consistent implementation of analytical methods and product specifications at CDMOs/contract laboratories
• Collaborate with CMC team members responsible for API and DP development and support to management
• Identify and manage relationships with external parties (CROs, CMOs, RM suppliers, consultants, etc.) including proposals, contracts, budgets, timelines, and due diligence
• Author/review CMC sections of regulatory filings and departmental SOPs, technical reports, specifications, CAPAs, change controls, investigations, and deviations
• Work with RA and QA to ensure up-to-date procedures and vendor compliance with cGXP regulations
• Participate as CMC subject matter expert in quality audits
• Identify opportunities to streamline in-house CMC analytical development activities
• Provide leadership, career management, and development to direct reports; recruit and develop top talent
• Any other projects (e.g., impurity identification and characterization) as appropriate

Qualifications

• Required: Bachelor‚Äôs or Master‚Äôs degree in analytical chemistry or related field with at least 12 years of related technical experience in biopharmaceutical development
• Required: Experience in a biotech/pharma setting focused on small molecules in late-stage development; strong experience in oral solid dosage forms
• Required: Experience managing relationships with CROs and contract laboratories
• Required: Proven expertise in method development and qualification/validation, characterization, and support of stability programs for small molecule API and oral DPs
• Required: Proficiency with HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, microbial techniques
• Required: Proficiency in at least two other areas of pharmaceutical development (e.g., solid state analysis, physical characterization, drug product dissolution)
• Required: Ability to train and mentor junior staff; experience reviewing release and stability data for trending and specification setting
• Required: Solid understanding of CGLP/CGMP, ICH, FDA, EMA guidelines; knowledge of late-stage product development requirements
• Required: Strong CGMP knowledge, quality systems, and ability to work independently and in a matrix environment
• Preferred: PhD in analytical chemistry or related field with substantial relevant experience
• Preferred: Mentoring or management experience

Skills

• Analytical problem solving and project leadership
• Strong communication skills, both written and oral
• Cross-functional collaboration and vendor management
• Attention to detail and ability to manage competing priorities

Education

• Bachelor‚Äôs or master‚Äôs degree in analytical chemistry or related field (required)
• PhD preferred (optional)

Additional Requirements

• Onsite presence in the lab required weekly
• Travel up to 20% may be required