CMC Project Leader
Sanofi
5 hours ago
Remote friendly (Framingham, MA)
United States
$206,250 - $297,916.66 USD yearly
Operations
Main Responsibilities:
- Lead a cross-functional CMC team (CMC R&D/IA; Mammalian DS platform, drug product/formulation, bioanalytics, device development, quality, regulatory CMC, CMC dossiers, project management, demand & supply).
- Oversee CMC and sub-teams of ~100–200 employees.
- Create an integrated CMC development plan aligned to global objectives.
- Represent CMC in the Global Project Team; contribute to project strategy and CMC actions.
- Define the Quality Target Product Profile (QTPP).
- Serve as overall product/process expert; drive technical/scientific alignment in CMC and R&D/M&S governance.
- Ensure quality of CMC contributions to clinical and PPQ work packages (DS/DP/Analytics) and regulatory submissions/consultations.
- Drive technical excellence; initiate/oversee CoGs evaluations; align strategy with commercial expectations.
- Evaluate CMC risks, escalate to senior management, and provide mitigation plans.
- Communicate risks that could impact critical program timelines.
- Implement CMC deliverables within budget (external/internal costs).
- Lead CMC project budget planning and alignment with global project team and senior management.
Basic Qualifications:
- BS/MS in biotechnology, pharmaceutical engineering/analysis, biochemistry, chemical engineering, or related; 16+ years relevant industry (or PhD with 12+ years).
- Experience in biologics development.
- CMC regulatory experience in IND filing.
- Experience leading international, cross-functional teams.
- Project management and risk assessment expertise.
- Demonstrated leadership; excellent communication skills; fluent English.
Preferred Qualifications:
- Biologics CMC expertise across at least two areas (analytics, process dev, regulatory CMC, manufacturing, etc.).
- Background in biotechnology/protein science.
- Matrix organization experience.
- Knowledge of pharma environment (economic/regulatory); BLA submission experience.
- Strong leadership, stakeholder management/networking, and coordination.
Benefits:
- At least 14 weeks’ gender-neutral parental leave; health and wellbeing benefits (high-quality healthcare, prevention and wellness programs).
- Lead a cross-functional CMC team (CMC R&D/IA; Mammalian DS platform, drug product/formulation, bioanalytics, device development, quality, regulatory CMC, CMC dossiers, project management, demand & supply).
- Oversee CMC and sub-teams of ~100–200 employees.
- Create an integrated CMC development plan aligned to global objectives.
- Represent CMC in the Global Project Team; contribute to project strategy and CMC actions.
- Define the Quality Target Product Profile (QTPP).
- Serve as overall product/process expert; drive technical/scientific alignment in CMC and R&D/M&S governance.
- Ensure quality of CMC contributions to clinical and PPQ work packages (DS/DP/Analytics) and regulatory submissions/consultations.
- Drive technical excellence; initiate/oversee CoGs evaluations; align strategy with commercial expectations.
- Evaluate CMC risks, escalate to senior management, and provide mitigation plans.
- Communicate risks that could impact critical program timelines.
- Implement CMC deliverables within budget (external/internal costs).
- Lead CMC project budget planning and alignment with global project team and senior management.
Basic Qualifications:
- BS/MS in biotechnology, pharmaceutical engineering/analysis, biochemistry, chemical engineering, or related; 16+ years relevant industry (or PhD with 12+ years).
- Experience in biologics development.
- CMC regulatory experience in IND filing.
- Experience leading international, cross-functional teams.
- Project management and risk assessment expertise.
- Demonstrated leadership; excellent communication skills; fluent English.
Preferred Qualifications:
- Biologics CMC expertise across at least two areas (analytics, process dev, regulatory CMC, manufacturing, etc.).
- Background in biotechnology/protein science.
- Matrix organization experience.
- Knowledge of pharma environment (economic/regulatory); BLA submission experience.
- Strong leadership, stakeholder management/networking, and coordination.
Benefits:
- At least 14 weeks’ gender-neutral parental leave; health and wellbeing benefits (high-quality healthcare, prevention and wellness programs).