Key Responsibilities：
1. Strategic Technical Leadership
· Process Design & Scale-up: Lead the design and execution of scale-up strategies for diverse dosage forms (e.g., solid orals, sterile injectables, nasal spray or topicals) using Quality by Design (QbD) principles.
· Tech Transfer Ownership: Serve as the primary technical point of contact for clients, ensuring the seamless transfer of "Sending Unit" (Client) processes to the "Receiving Unit" (CDMO).
· Troubleshooting: Act as the ultimate Subject Matter Expert (SME) for complex formulation challenges, deviations, and "out of specification" (OOS) investigations during the transfer phase.
2. Operational Excellence
· Facility Fit & Gap Analysis: Conduct technical assessments of incoming client processes against existing site equipment and capabilities; identify and procure necessary capital equipment.
· Documentation Oversight: Review and approve Tech Transfer Protocols, Master Batch Records (MBRs), Process Validation protocols, and Technical Transfer Reports.
· Regulatory Support: Author and review technical sections of regulatory filings (e.g., IND, NDA, BLA, ANDA) and represent the technical team during PAI (Pre-Approval Inspections).
3. Client & Project Management
· Stakeholder Liaison: Work closely with Business Development to evaluate new RFPs (Requests for Proposals) and provide technical man-hour and resource estimates.
· Timeline Management: Ensure tech transfer milestones (Engineering batches, Clinical supply, PPQ) are met to support client clinical or launch timelines.---
Qualifications & Skills
Education
· Required: Ph.D. or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related field.
Experience
· Industry: 10+ years in pharmaceutical development/manufacturing, with at least 5 years specifically in a CDMO environment.
· Leadership: 5+ years of experience managing high-performing technical teams.
· Technical: Proven track record of successful tech transfers and at least 2–3 successful commercial product launches.
Technical Proficiencies
· Deep understanding of cGMP, ICH guidelines (Q8, Q9, Q10, Q11), and global regulatory requirements (FDA, EMA, NMPA).
· Expertise in statistical tools for process monitoring (e.g., JMP, Minitab).
· Experience with Risk Assessment tools (FMEA) to identify and mitigate process risks.
To apply:
Candidates are encouraged to apply this position via email to Phghr@pharmagend.com with the following information in the resume.
• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background
We regret that only shortlisted candidates will be contacted.
