Senior Project Manager

Job ID: 7778 Job Title: Senior Project Manager Location: Bethlehem, PA

Job Title: Senior Project Manager or Director, CMC & Client Partnerships

(Title will depend on qualifications)

Job Summary

The Senior Project Manager or Director, CMC & Client Partnerships, serves as the primary liaison between our external clients and internal CDMO technical teams (Formulation, Analytical, Process Development, Manufacturing, and Quality Assurance). This role is responsible for driving the successful execution of pharmaceutical development projects from development to commercial manufacturing, ensuring adherence to CMC regulatory standards, project timelines, and budgetary constraints.

Key Responsibilities

• External Client Stewardship: Act as the primary point of contact for clients, translating complex technical challenges into clear, actionable updates. Manage client expectations, facilitate regular updates, and maintain high satisfaction throughout the project lifecycle.
• CMC Project Leadership: Lead cross-functional project teams to deliver CMC development and manufacturing programs.
• Timeline & Milestone Management: Develop, maintain, and track detailed project timelines, critical paths, and deliverables to ensure on-time project completion.
• Project Oversight & Risk Management: Proactively identify risks (e.g., process issues, supply shortages) and implement mitigation strategies.
• Internal Coordination: Coordinate internal departments (QA, QC, R&D, Supply Chain) to align with client goals and project scope.
• Financial Accountability: Track project financials, manage change orders, and work with business development to ensure budget alignment.

Qualifications

• Education: B.S. or M.S. in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related scientific field.
• Experience:
• Minimum 5–8 years of experience in the pharmaceutical or CDMO industry.
• Proven experience in CMC development, tech transfer, or GMP manufacturing.
• Direct experience in client-facing project management.
• Knowledge:
• Understanding of FDA regulations.
• Familiarity with Drug Product formulation and process development.
• Skills:
• Excellent oral and written communication skills for high-stakes client meetings.
• Proficiency in project management tools (e.g., MS Project, SmartSheet).
• Strong problem-solving abilities and ability to work under tight deadlines.

Preferred Qualifications

• Bilingual, English and Chinese (not required).
• PMP (Project Management Professional) Certification.
• Experience with injectables, ophthalmics, drug implants, and medical devices.