Senior Director, Analytical Development CMC
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Analytical CMC leader overseeing development and QC for Iambic Therapeutics’ AI-discovered small-molecule medicines. Guiding methods, stability, regulatory filings, CDMOs, and teams from clinical development through commercialization.
Responsibilities:
- Lead analytical development and QC functions within CMC
- Provide scientific, strategic, and operational oversight across Iambic’s small-molecule portfolio from early clinical development through late-stage development and commercialization
- Lead phase-appropriate analytical strategies for drug substance and drug product
- Oversee analytical method development, transfer, validation, specifications, impurity control, stability, reference standards, product characterization, and release testing
- Serve as primary Analytical Development/QC lead for internal cross-functional teams and external CDMOs/testing labs
- Lead DS and DP analytical strategy and scientific oversight across characterization, impurity and degradation-product control, reference standards, comparability, and stability
- Assess shelf-life/retest periods and emerging stability risks
- Oversee QC release and stability testing, OOS/OOT investigations, deviations, root-cause assessments, CAPAs, and analytical issue resolution
- Establish scientifically justified specifications and analytical acceptance criteria
- Lead dissolution and product-performance testing, including QC and discriminatory methods for oral drug products
- Lead outsourced analytical and QC network partner selection, technical oversight, governance, issue resolution, and performance management
- Partner with Drug Substance, Drug Product, Quality, Regulatory CMC, Clinical Supply, and other cross-functional teams to support timelines and manufacturing readiness
- Lead analytical CMC support for global regulatory submissions and health authority interactions
- Author and review Module 3 content, specifications and justifications, analytical methods, stability sections, and regulatory-query responses
- Recruit, lead, coach, and develop team members
- Oversee functional resource planning and budget proposals
- Foster a collaborative, high-performing environment aligned with organizational goals
Requirements:
- Ph.D. in Analytical Chemistry or a related field with 12+ years of experience in the pharmaceutical/Biotech industry, or an M.Sc. with 14+ years, or a B.Sc. with 17+ years of experience
- Extensive hands-on experience in analytical method development, transfer, troubleshooting, and validation for small molecule drug substance and drug product across early and late-stage development
- Strong experience developing phase-appropriate analytical control strategies, including specifications, impurity/degradation-product control, reference standards, stability-indicating methods, dissolution, and product characterization
- Demonstrated experience supporting early and late-stage development and regulatory filings, including IND/IMPD and preferably NDA/MAA
- Proven success leading Analytical Development and QC activities through external CDMOs, including technical oversight, issue resolution, and management of multiple programs and partners
- In-depth knowledge of cGMP laboratory operations, global regulatory expectations, and relevant ICH guidance
- Strong experience with analytical methods for enabling formulations and conventional oral solid dosage forms
- Proven leadership experience building collaborative, high-performing teams and working effectively across Drug Substance, Drug Product, Quality, Regulatory CMC, Clinical Supply, and other functions
- Excellent written and verbal communication skills, with ability to communicate technical issues, risks, and recommendations to internal stakeholders, external partners, and health authorities
- Ability to travel up to 15% domestically and internationally
- Must be currently authorized to work in the United States
- Must address analytical strategy, a technical or regulatory challenge, and outcome in a 100–250-word application response
Benefits:
- Company-paid healthcare
- Flexible spending accounts
- Voluntary life insurance
- 401(k) matching
- Uncapped vacation
- Onsite gym
- Onsite dining
- Brand-new state-of-the-art facility
- Easy access to great places to live and play
Similar Jobs
Director, Global BPO and Transformation
Director governing Fiserv’s global outsourced merchant support operations and transformation. Improving vendor performance, service transitions, and merchant outcomes across partner sites.
Director – Utilization Management
Directing Centene’s utilization management team and operations. Improving healthcare outcomes, compliance, cost effectiveness, and member and provider experience.
Director, Bank Relationship Management
Fiserv fintech director leading bank relationship managers across Midwest remote locations. Driving client retention, renewals, revenue growth, and strategic financial-institution partnerships.
Used Vehicle Director
Used Vehicle Director leading used-car sales, inventory, pricing, and trade strategy across AutoNation dealerships in Texas. Driving market-wide performance, compliance, and operational excellence.
Director, Payments
Director of Payments scaling CARET Pay, embedded payments integrated into legal practice management software. Owning go-to-market strategy, merchant activation, P&L, and processor relationships.
Clinical Project Director – EDS
Clinical Project Director leading global evidence-development programs at UBC Evidence Development Solutions. Overseeing clinical research operations, project finances, quality, clients, and cross-functional teams.
Clinical Development Director – Early Development Oncology
Clinical Development Director advancing Amgen’s oncology medicines from first-in-human studies through proof-of-concept. Designing trials, reviewing data, and guiding early development teams.
Director, Disaster Human Services
ICF disaster human services director leading federal emergency repatriation and crisis-response operations. Advising clients, coordinating partners, and strengthening readiness, deployment, and mission execution.
Director, Value Outcomes Liaison
Director guiding US payer access and value strategy for Summit Therapeutics’ investigational oncology immunotherapy. Communicating clinical and economic evidence to decision-makers and shaping formulary pathways.
Director, Value Outcomes Liaison – Central US
Director advancing payer access for Summit Therapeutics’ investigational oncology immunotherapy, ivonescimab. Engaging US decision-makers with clinical, economic, and humanistic evidence.
Associate Director – Incident, Problem, Change, Operational Resilience
Associate Director leading incident, problem, change, and operational resilience for Kyndryl’s mission-critical technology services. Driving enterprise reliability, governance, executive communications, and recovery improvements.
Associate Director – Strategic Programs
Strategic programs leader driving cross-functional growth, operational transformation, and AI adoption. Supporting executive reporting and board-level planning at cybersecurity compliance provider A-LIGN.
Director, Strategic Accounts
Director of Strategic Accounts growing LAWO’s enterprise broadcast and media technology relationships across North America. Expanding strategic accounts through complex broadcast infrastructure solutions, consultative sales, and executive engagement.
Director – Channel Accounts
Channel sales director growing reseller-driven revenue for Uniguest’s managed IPTV, digital signage, and interactive technology solutions. Leading channel managers, strategic partners, and enterprise opportunities.
Director, Corporate Engagement – Healthcare
Director expanding pharmaceutical and healthcare partnerships for Direct Relief’s global medical relief programs. Managing corporate relationships, donations, fundraising, and engagement strategy.
Director – Channel Accounts
Channel sales director leading reseller strategy, enterprise pipeline, and sales teams for Uniguest’s managed IPTV, digital signage, and kiosk solutions. Driving partner revenue across U.S. AV/IT markets.
Director of Technology
Director of Technology leading scalable SaaS architecture and global engineering at Norwegian-owned Sperton. Shaping AI-enabled products, commercial growth, fundraising, and executive technology strategy.
Associate Director, ExploR&D Consultation Agreements
Associate Director negotiating high-volume consultation agreements for Lilly ExploR&D. Translating biotech scientific scopes into precise commercial terms and executed contracts.
Associate Director, Quality Improvement
Associate Director leading Ohio Medicaid quality improvement, HEDIS, CAHPS, compliance, and population-health strategy at Humana. Managing quality teams, providers, vendors, and enterprise-wide clinical improvement programs.
Regional Director
Regional Director advancing the Rocky Mountain Elk Foundation’s elk conservation mission through Utah volunteer chapters. Leading grassroots fundraising, volunteer development, and conservation grant oversight.