Job Description

Job Title: Project/Program Manager - Small Molecules API (CDMO)
Client: Leading Contract Development & Manufacturing Organization (CDMO)
Position Type: Full-time
Role Overview
We are seeking an experienced Project/Program Manager to lead and coordinate small molecule API development and manufacturing projects within a CDMO environment. The role requires strong technical understanding of API development, regulatory compliance, and proven ability to manage cross-functional teams while serving as the primary client interface.
Key Responsibilities
Lead end-to-end project management for small molecule API programs, from development through commercial manufacturing.
Serve as the primary point of contact for clients, ensuring clear communication, alignment, and satisfaction.
Develop and track project plans, timelines, budgets, and deliverables, ensuring milestones are achieved.
Coordinate cross-functional teams (R&D, Process Development, Manufacturing, QA/QC, Regulatory) to drive project execution.
Manage risk assessments, change controls, and mitigation strategies for project challenges.
Ensure compliance with USFDA, EMA, and ICH guidelines across all project activities.
Prepare and present status reports, dashboards, and executive updates for internal and client stakeholders.
Drive continuous improvement initiatives in project management processes and client engagement.
Mentor junior project managers and contribute to building a high-performance PMO culture.
Qualifications:
Bachelor's/Master's degree in Pharmaceutical Sciences, Chemical Engineering, or related field.
8-12 years of experience in project/program management within pharma/biotech, with focus on API/CDMO projects.
Strong knowledge of small molecule development, scale-up, and tech transfer.
Familiarity with regulatory frameworks (USFDA, EMA, ICH) and GMP environments.
Proven track record of client relationship management and delivering complex projects on time.
Excellent organizational, communication, and leadership skills.
PMP/Prince2 certification preferred.
Desired Attributes
Strategic thinker with ability to balance technical detail and business priorities.
Collaborative leader who thrives in a matrix environment.
Proactive problem solver with strong stakeholder management skills.

Skills Required