Director, Analytical Development (In-House)

Role Summary

The Director, CMC Analytical will report to the Senior Director, Analytical Development and Quality Control. The analytical organization supports in-house analytical development and external CDMO activities, serving as a subject matter expert to solve complex analytical challenges for small molecule therapeutics in rare endocrine disorders and endocrine-related tumors. This role is in a small company environment in San Diego’s biotechnology community.

Responsibilities

• Establish, direct, and monitor CMC testing methodologies and specifications for raw materials, intermediates, excipients, APIs, and drug products with a focus on oral dosage
• Lead analytical development activities for assigned projects and deliver results for CMC Analytical
• Develop departmental processes to achieve department and corporate goals; focus on short-term strategic planning (<2 years)
• 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 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
• Identify, evaluate, and manage external relationships with CROs, CMOs, RM suppliers, consultants; manage RFPs, SOWs, contracts, budgets, timelines, and due diligence
• Author and review CMC sections of regulatory filings and departmental SOPs, guidelines, and related documents
• Work with RA and QA to ensure quality system compliance with cGXP regulations
• Participate as CMC SME in quality audits
• Identify opportunities to streamline in-house CMC analytical development activities
• Provide leadership and development to direct reports; recruit and align talent to business needs
• Other projects (e.g., impurity identification) as appropriate

Qualifications

• Required: Bachelor’s or master’s degree in analytical chemistry or related field with at least 12 years of relevant experience in biopharmaceutical development
• Experience in biotech/pharma with focus on small molecules in late-stage development and extensive experience in oral solid dosage forms
• Experience managing relationships with Contract Research Organizations and contract laboratories
• Proven expertise in method development, qualification/validation, characterization, and stability program support for small molecule APIs and oral DPs
• Proficient with HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, microbial analyses; proficient in at least two other areas of pharmaceutical development
• Experience training and mentoring junior staff; ability to analyze release and stability data for trending and specification setting
• Strong understanding of CGLP/CGMP, ICH, FDA, EMA guidelines; knowledge of late-phase product development requirements
• Strong CGMP knowledge, quality systems, and ability to work independently and in a matrix team; strong communication skills
• Desirable: mentoring/managing others
• Strong organizational skills and attention to detail

Skills

• Analytical chemistry
• Regulatory writing for CMC sections
• Vendor management and project management
• Data analysis and trend interpretation
• Cross-functional collaboration

Education

• Bachelor’s or Master’s degree in analytical chemistry or related field

Travel and Physical Requirements

• Travel up to 20% may be required
• Role requires weekly onsite presence in the lab; some lifting up to 25 lbs; standard laboratory environment