Director, CMC Analytical
RemoteUnited States
Job Summary
Spearhead analytical development, quality control, and regulatory support activities for active pharmaceutical ingredients and drug products across clinical and late-stage programs. Provide technical leadership for method development, specification establishment, and stability programs while overseeing API and DP release testing. Author and review regulatory filings including INDs, IMPDs, and NDAs to support global clinical studies and commercial launch readiness. Manage change controls, deviations, and investigation reports while driving adoption of quality-by-design approaches. Collaborate with CMC, clinical, regulatory, and commercial teams to prioritize analytical activities and ensure inspection readiness. This remote role requires in-person attendance in the New England area during commercial launch phases.
Required Qualifications
- PhD in analytical chemistry or a related field
- At least 12 years of analytical team leadership in the biotechnology or pharmaceutical industry
- Experience managing and building strong relationships with contract manufacturing organizations
- Experience in early and late-stage programs, commercialization, commercial product support, launch transition, post-approval commitments, and life cycle management
- Extensive technical expertise in analytical method development and validation for API and DP, characterization, and stability of solid oral dose
- Proficiency in reviewing and analyzing release and stability data for trending, shelf-life, and specification establishment
- Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability
- Proficiency in writing RFPs, protocols, reports, and regulatory documents
- Exceptional interpersonal, negotiation, problem-solving, communication, and analytical skills
- Must be well-organized
- Must be proactive
- Must be detail-oriented
- Demonstrates voracious intellectual curiosity
- Demonstrates innovation
- Demonstrates creative problem-solving
- Has an entrepreneurial spirit
- Has a keen sense of urgency
- Can thrive in an agile environment
- Ability to thrive in a fast-paced, high-growth, matrixed startup biotechnology environment
- Ability to balance strategic thinking with operational excellence and hands-on execution across both clinical and commercial asset needs
- Project management skills including the ability to manage multiple projects
- Ability to assess interpersonal relationships across multiple disciplines in product development
- Ability to identify gaps that may impact critical milestones
- Ability to assess, adjust, and maintain timelines as required by project needs
- Ability to evaluate project resources
- Strong verbal and written communication skills
- Ability to build relationships internally and externally
- Willingness to travel to various meetings or client sites, domestically or internationally when necessary
- In-person attendance in the New England area based on business needs and work requirements rather than a set office schedule
- Increased frequency during commercial launch planning and launch-related activities
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