Associate Director, Small Molecule Analytical Sciences

Role Summary

Associate Director, Small Molecule Analytical Sciences. This position provides managerial oversight and technical outputs for the Small Molecule Analytical Sciences function within Arcus’s Pharmaceutical Development & Manufacturing organization. Onsite role including technical report writing, CDMO management and laboratory responsibilities for assigned projects in support of small molecule drug substance and drug product development and manufacturing.

Responsibilities

• Authoring technical development reports and drafting/authoring regulatory CMC/analytical sections for IND, IMPD (and equivalent global filings), NDA, and responses to agency questions
• Method development, impurity characterization, experimental design, and analytical testing
• Management of CDMO/CRO activities (i.e., release, stability, method validation/transfer)
• Manage/Conduct in-house testing to support internal drug substance and drug product development
• Review and approval of internal and CDMO analytical data and deliverables
• Infrastructure development, such as authoring SOPs, guidelines, and contributing to enhancement of in-house laboratory capability
• Collaborate with cross-functional CMC teams (including QA and Regulatory) to achieve project goals
• Potential to serve as analytical lead on CMC teams, and must be able to make technical decisions, guide strategy and escalate risk appropriately

Qualifications

• Degree and experience:
  • PhD with 7+ years of relevant industry work experience;
  • or MS with 9+ years of relevant industry work experience;
  • or BS with 11+ years of relevant industry work experience
• Proven track record supporting small molecule drug substance and drug product development from early to late phase, with strong preference given to those with direct experience preparing for and contributing to NDA filing
• Demonstrated hands-on experience writing CMC analytical sections of regulatory submissions and handling agency queries, with strong preference for those that have authored global filings
• Strong understanding of regulatory requirements (pertinent to innovator drugs), ICH and regional health authority guidelines (FDA, EMA, MHRA, PMDA, etc.), and experience in executing phase-appropriate practices, particularly those relevant to late phase development
• Expertise in chromatography (primarily HPLC), impurity analysis (and control strategy), mass spectrometry, dissolution method development
• Extensive practical experience in small molecule analytical testing techniques (e.g., HPLC, GC, MS, Karl Fischer, dissolution)
• Experience in setting specifications, performing product characterization and comparability studies, conducting formal stability studies, method development/validation, and lifecycle management
• Substantial experience in managing CDMOs/CROs for analytical work (method transfer, validation, stability studies)
• Understanding of and experience in GMPs pertinent to analytical testing, including change controls, CAPAs, deviations, investigation reporting
• Excellent communicator and technical writer with evidence of writing high-quality regulatory documents and relevant supporting technical reports
• Strong technical decision maker, with excellent awareness of timelines, and able to work under tight deadlines in a fast-paced environment
• Hands-on, detail-oriented, committed to ownership and follow-through

Skills

• Analytical method development and validation
• Regulatory writing and CMC documentation
• CDMO/CDMO management and vendor oversight
• Regulatory knowledge (FDA, EMA, MHRA, PMDA, ICH guidelines)
• Chromatography (HPLC), mass spectrometry, dissolution testing
• Quality systems and GMPs, CAPAs, deviations, change controls
• Technical leadership and decision making

Education

• PhD/MS/BS in a relevant scientific discipline (e.g., Chemistry, Analytical Chemistry, Pharmaceutical Sciences) as applicable per experience requirements

Additional Requirements

• PHYSICAL REQUIREMENTS: Frequent standing/walking, lifting up to 40‚Äì50 pounds; occasional sitting/kneeling; ability to perform desk-based tasks; vision correctible
• WORKING CONDITIONS: May require work near blood borne pathogens, hazardous materials; use of PPE; potential extended or unusual hours