Project Manager - CDMO ( Drug Product)

Job Title: Project Manager - CDMO (Drug Product/Formulations)

Reports To: Head PM

Job Purpose : To lead the end-to-end execution of Drug Product (DP) development and manufacturing projects. The PM ensures that formulation development, analytical characterization, and clinical/commercial batch manufacturing are delivered on time, within budget, and in strict compliance with global regulatory standards (FDA, EMA, etc.).

Key Responsibilities

1. Project Initiation & Strategy

• Proposal Management: Partner with Marketing and BD to evaluate RFPs/RFIs specifically for dosage form development (Oral Solids, Injectables, Topicals, etc.). Define the technical scope based on the molecule's complexity.
• Charter & Scope: Conduct kick-off meetings to define Target Product Profile (TPP) and Quality Target Product Profile (QTPP). Develop a Project Charter capturing development phases (Pre-formulation to Pivotal/Registration batches).

2. Detailed Project Planning

• Resource & Financial Planning: Create a Detailed WBS covering Formulation Development (F&D), Analytical Method Development (AMD), Stability Studies, and Scale-up. Manage financial plans for Excipients, APIs, and Primary/Secondary Packaging materials.
• Risk & Quality Planning: Identify risks related to Scale-up, Bioequivalence (BE) failures, and Stability. Ensure Quality by Design (QbD) principles are integrated into the planning phase.
• Operational Planning: Coordinate facility mapping for Pilot Plants and GMP Manufacturing suites. Manage procurement of specific excipients and specialized packaging components with SCM.

3. Project Execution, Monitoring & Control

• Timeline & Cost Tracking: Rigorous monitoring of the Gantt chart, focusing on critical path items like Stability data time-points and Clinical Trial Material (CTM) readiness.
• Execution Management: Oversee Lab-scale trials, Exhibit batches, and Process Validation. Conduct Daily LDM (Lean Daily Management) and Gemba walks in the Formulation suites to ensure First Time Right manufacturing.
• Change Management: Manage deviations and change controls related to manufacturing processes or analytical methods, ensuring timely CAPA implementation to avoid project delays.
• Communication: Serve as the bridge between the customer and the Cross-Functional Team (CFT). Lead weekly PET meetings and bi-weekly Project Review Meetings (PRM).

4. Project Closure & Archival

• Deliverables: Ensure completion of the Development Report, Technology Transfer Dossier (TTD), and successful dispatch of clinical/commercial samples.
• Financial Reconciliation: Analyze variances in material yields and labor hours. Evaluate the profitability of the formulation cycle.
• Lessons Learned: Document insights on formulation challenges (e.g., flowability, degradation) to improve future DP project frameworks.

5. Customer & Audit Management

• Key Account Support: Assist KAMs in identifying follow-on opportunities, such as life-cycle management or line extensions for existing DP clients.
• Audits: Coordinate customer and regulatory audits (GMP/PHE). Ensure all observations regarding Batch Records (BMR/BPR) and analytical data integrity are closed promptly.

Minimum Requirements

• Education: Post Graduate in Pharmacy (M.Pharm) / Chemical Engineering / MBA.
• Experience: * Minimum 10 years of experience.
• Direct experience in Project Management within a CDMO DP (Drug Product / Formulations) environment is mandatory.
• Proven track record of managing projects from Pre-formulation through to Commercial Launch.
• Technical Knowledge:
• In-depth understanding of CDMO DP Business (Oral solids, sterile, liquids, etc.).
• Strong grasp of PM tools (MS Project, Jira, or similar) and PMBOK/Prince2 concepts.
• Knowledge of Regulatory filings (ANDA/NDA/Dossier) and Stability testing protocols.
• Behavioral Competencies:
• Matrix Leadership: Ability to drive results across F&D, Analytical, QA, and Manufacturing teams.
• Strategic Influence: Strong communication skills to manage high-pressure customer expectations and internal resource constraints.
• Problem Solving: A First Time Right mindset with the ability to pivot when stability or scale-up challenges arise.