CMC Project Leader
Sanofi
9 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 a strategic, integrated CMC development plan aligned to global project objectives.
- Serve as core member of the Global Project Team to drive CMC actions toward project goals.
- Define the Quality Target Product Profile (QTPP).
- Act as product/process expert; provide technical/scientific expertise; lead alignment in CMC and R&D/M&S governance meetings.
- 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 and escalate CMC risks; provide mitigation plans.
- Alert stakeholders to risks impacting critical timelines.
- Deliver CMC work within budget (external/internal costs).
- Plan and communicate the CMC project budget with global teams and senior management.
Basic Qualifications:
- BS/MS in biotechnology, pharmaceutical engineering, pharmaceutical analysis, biochemistry, chemical engineering, or related + 16 years relevant industry experience, or PhD + 12 years.
- Experience in biologics development.
- CMC regulatory experience in IND filing.
- Experience leading international, cross-functional teams.
- Expertise in project management and risk assessment.
- Demonstrated leadership.
- Excellent communication skills; fluency in English.
Preferred Qualifications:
- Biologics CMC expertise across at least two areas (analytics, process dev., regulatory CMC, manufacturing, etc.).
- Background in biotechnology/protein science.
- Experience in matrix organizations.
- Understanding of current pharmaceutical environment; experience with BLA submission.
Benefits (explicitly stated):
- Wide range of health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.
- 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 a strategic, integrated CMC development plan aligned to global project objectives.
- Serve as core member of the Global Project Team to drive CMC actions toward project goals.
- Define the Quality Target Product Profile (QTPP).
- Act as product/process expert; provide technical/scientific expertise; lead alignment in CMC and R&D/M&S governance meetings.
- 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 and escalate CMC risks; provide mitigation plans.
- Alert stakeholders to risks impacting critical timelines.
- Deliver CMC work within budget (external/internal costs).
- Plan and communicate the CMC project budget with global teams and senior management.
Basic Qualifications:
- BS/MS in biotechnology, pharmaceutical engineering, pharmaceutical analysis, biochemistry, chemical engineering, or related + 16 years relevant industry experience, or PhD + 12 years.
- Experience in biologics development.
- CMC regulatory experience in IND filing.
- Experience leading international, cross-functional teams.
- Expertise in project management and risk assessment.
- Demonstrated leadership.
- Excellent communication skills; fluency in English.
Preferred Qualifications:
- Biologics CMC expertise across at least two areas (analytics, process dev., regulatory CMC, manufacturing, etc.).
- Background in biotechnology/protein science.
- Experience in matrix organizations.
- Understanding of current pharmaceutical environment; experience with BLA submission.
Benefits (explicitly stated):
- Wide range of health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.