Director, Analytical Development

Role Summary

The Director, Analytical Development will lead analytical development activities for small molecule therapeutics, overseeing testing methodologies, collaborations with external CROs/CDMOs, and regulatory CMC content to support late-stage development.

Responsibilities

• Establish, direct, and monitor implementation of Tech Ops testing methodology and specifications for raw materials, intermediates, excipients, APIs, and drug products, with focus on oral dosage
• Lead analytical development activities of assigned projects and deliver results for CMC/Tech Ops 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
• Review and approve protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials
• 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 Tech Ops team members responsible for API and DP development and support
• Identify, evaluate, and manage external relationships (CROs, CMOs, RM suppliers, consultants); manage proposals, SOWs, contracts, budgets, timelines, and vendor due diligence
• Author and review CMC sections of regulatory filings (INDs, IMPDs, NDAs, briefing packages, etc.)
• Author/review SOPs, guidelines, reports, specifications, CAPAs, change controls, investigations, and deviations to ensure cGMP compliance
• Work with RA and QA on quality systems to ensure vendor compliance with cGXP
• Participate as CMC/Tech Ops subject matter expert in quality audits
• Identify opportunities to streamline in-house CMC analytical development
• Provide leadership, career management, and development to direct reports; recruit and develop top talent
• Other projects (impurity identification/characterization) as appropriate

Qualifications

• Bachelor‚Äôs degree in Analytical Chemistry or related field with 12+ years in analytical development in biopharmaceuticals; or MS/PhD with at least 10 years of relevant experience
• 8+ years in a supervisory role
• Experience in biotech/pharma with focus on small molecules in late-stage development; extensive experience in oral solid dosage forms
• Experience managing relationships with CROs and contract laboratories
• Expertise in analytical testing, method development, qualification/validation, characterization, and stability programs for small molecule API and oral DPs
• Proficient with HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, microbial techniques; proficient in at least two other areas of pharmaceutical development
• Strong track record in managing analytical activities and overcoming challenges; experience reviewing release and stability data
• Solid understanding of CGLP/CGMP, ICH/FDA/EMA guidelines for product development and manufacture including stability
• Extensive knowledge of CGMP and quality systems; ability to work in late-stage development environments
• Excellent written and verbal communication; ability to present data to peers, management, and external partners
• Ability to work independently and in a matrix team; effective at prioritization; mentoring skills; adaptability and attention to detail
• Strong organizational skills

Skills

• Analytical testing and method development
• Regulatory filing (CMC) and QA collaboration
• Vendor management and external collaboration
• CGLP/CGMP compliance and quality systems
• Regulatory knowledge (ICH, FDA, EMA)
• Leadership and people development

Education

• Bachelor‚Äôs degree in Analytical Chemistry or related field; advanced degree preferred

Additional Requirements

• Travel up to 20%
• Physical demands: standard office/workbench activities; occasional lifting up to 25 lbs; laboratory environment as applicable