Director, Analytical Development (In-House)

Role Summary

The Director, CMC Analytical will report to the Senior Director, Analytical Development and Quality Control. The Tech Operations team collaborates with a global network of CROs and CDMOs to support in-house analytical development and external testing. The role serves as the Subject Matter Expert in analytical development, providing expertise to solve complex analytical challenges supporting the discovery and development of small molecule therapeutics for rare endocrine disorders and endocrine-related tumors. This position offers the opportunity to work in a small-company environment in San Diego's biotechnology community.

Responsibilities

• Establish, direct, and monitor implementation of CMC testing methodologies and specifications for raw materials, intermediates, excipients, APIs and drug products, with 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 immediate and short-term (<2 year) strategic planning horizon.
• Work closely with external CRO/CDMO collaborators to advance method development, qualification, transfer, and validation for API and DP for advanced programs.
• 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-trend/out-of-specification reports.
• Ensure consistent implementation of analytical methods and product specifications at CDMOs/contract laboratories.
• Collaborate with other CMC team members responsible for API and DP development and support to management, as necessary.
• Identify, evaluate, and manage relationships with external parties (CROs, CMOs, RM suppliers, consultants) including writing/reviewing RFPs/SOWs, contracts, budgets, timelines, and due diligence.
• Author and review CMC sections of regulatory filings (INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers).
• Author and/or review SOPs, technical reports, specifications, CAPAs, change controls, investigations, and deviations to ensure cgMP compliance.
• Work with RA and QA on quality systems to ensure up-to-date procedures and vendor compliance with cGXP regulations.
• Participate as CMC subject matter expert in quality audits.
• Identify and promote opportunities to streamline in-house CMC analytical development activities.
• Provide leadership, career management, and development to direct reports; recruit and develop top talent; align team to business needs.
• Other projects (impurity identification and characterization, etc.) as deemed appropriate.

Qualifications

• Required: Bachelor’s or Master’s degree in analytical chemistry or related field with at least 12 years of related technical experience with increasing responsibility in biopharmaceutical development plus a minimum of 8+ years in a supervisory role
• Required: Work experience in a biotech or pharma company (with a focus on small molecules in late phase of development) and extensive experience in oral solid dosage forms
• Required: Experience in relationship management of Contract Research Organization and contract laboratories
• Required: Proven expertise in method development and phase-appropriate qualification/validation, characterization, and support of stability programs for small molecule API and oral DPs
• Required: Proficient with techniques that include but are not limited to HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, microbial
• Required: Proficient in at least two other areas of pharmaceutical development (e.g., solid state analysis, physical characterization, drug product dissolution)
• Required: Assist in training and mentoring junior laboratory technicians and new staff members
• Required: Experience in reviewing and analyzing release and stability data for trending, shelf-life and specification setting
• Required: Solid understanding of CGLP and CGMP requirements, compendia testing, ICH, FDA, and EMA guidelines with a focus on product development and manufacture, including stability requirements
• Required: Extensive knowledge of CGMP, quality systems and industry standards and thorough understanding of requirements for products in late phase of development
• Required: Excellent interpersonal and communication skills (written and oral)
• Required: Excellent ability to work both independently and in a matrix team environment, in a goal and team-oriented setting and handle competing priorities
• Required: Although not required, ability and interest in mentoring and/or managing others
• Required: Flexibility within a rapidly changing environment and high attention to detail
• Required: Well-developed organizational skills and detail oriented
• Preferred: Ph.D. in analytical chemistry or related field with at least 10 years of related technical experience

Education

• Required: Bachelor's or Master's degree in analytical chemistry or related field; 12+ years of biopharmaceutical development experience with at least 8 years in a supervisory role
• Preferred: Ph.D. in analytical chemistry or related field

Skills

• Analytical method development, qualification/validation, and stability program support for small molecule APIs and oral drug products
• CMC documentation for regulatory filings (INDs, IMPDs, NDAs, briefing packages)
• Vendor management and CRO/CMO relationships
• Cross-functional collaboration with RA/QA and other CMC team members
• Technical proficiency: HPLC, GC, KF, IC, LC-MS, UV-Vis, XRPD, microbial analyses
• Solid-state analysis, physical characterization, dissolution
• Leadership and mentoring of scientists and staff
• Strong written and verbal communication

Additional Requirements

• Onsite presence in the lab is required; relocation assistance is not available
• Travel up to 20% may be required
• Physical demands: ability to sit for long periods; some walking and lifting up to 25 lbs; laboratory environment