Position / Job Title
Technical Project Manager Site Transfers (ANDA / NDA Products)
Department
External Manufacturing/ CMO Head
Reporting To
CMO Head
Location
Pithampur/ Thane
Years of Experience
5+ Years
Dosage Form
Solid Oral / Nasal / Liquid
Job Responsibilities / Deliverables
- Technology Absorption & Knowledge Transfer
Lead technical due diligence and absorption of product and process knowledge from donor sites.
Review and understand complete product and process history, including but not limited to:
Batch Manufacturing Records (BMRs)
Annual Product Quality Reviews (APQRs / PQRs)
Process Validation (PV) reports
Cleaning Validation and Hold Time studies
Analytical Method Validation / Transfer reports
Stability data and trends
Change history, deviations, CAPAs, OOS/OOT history
Identify critical process parameters (CPPs), critical quality attributes (CQAs) and key risk areas during transfer.
- Site Transfer Planning & Execution
Develop and manage detailed technical transfer plans, timelines, and deliverables.
Coordinate with donor and receiving sites to ensure accurate and complete technology transfer packages.
Ensure alignment of equipment, utilities, process controls, and analytical capabilities at receiving sites.
Drive scale-up strategy, including risk assessment for equipment and batch size changes.
- Exhibit, Scale-Up & Validation Batches
Provide On-site Technical Leadership During
Scale-up batches
Exhibit batches
Process validation (PPQ) batches
Support execution, real-time troubleshooting, deviation assessment, and corrective actions.
Ensure batch execution aligns with approved regulatory filings and transfer protocols.
- Technical Interface with CMOs & Internal Teams
Act As The Primary Technical Liaison Between Rubicon And
CMO technical, manufacturing, QA, QC and engineering teams
Internal Rubicon functions MS&T, QA, Regulatory Affairs, Engineering
Lead technical discussions, meetings, and decision-making related to process, quality, and compliance.
- Regulatory & Compliance Alignment
Ensure All Transfer Activities Comply With
Approved ANDA / NDA filings
USFDA, EMA And Other Applicable Regulatory Requirements
Rubicon Quality Management System (QMS)
Support regulatory submissions, responses to agency queries, and inspection readiness related to site transfers.
Participate in regulatory inspections or audits at receiving sites, as required.
- Cross-Functional Coordination (Logistics & Readiness)
Coordinate With Supply Chain / Project Coordinators For
Availability and delivery of raw materials, packing materials and reference standards
License, permit and regulatory readiness at receiving sites
While supporting logistics coordination, retain prime ownership of all technical decisions and outcomes.
- Risk Management & Continuous Improvement
Proactively identify technical and compliance risks during site transfers and implement mitigation plans.
Capture and document lessons learned to improve future transfers.
Support standardization of site transfer frameworks, templates, and best practices across Rubicon.
Key Interfaces
CMOs (India & USA) Technical, Manufacturing, QA, QC
Internal: MS&T, Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, Engineering
External: Regulatory bodies (as needed), vendors, consultants
Qualifications & Pre-Requisites
Bachelor's or Master's degree in Pharmacy, Chemical Engineering, Pharmaceutical Sciences, or related discipline
815 years of experience in pharmaceutical manufacturing, MS&T, technology transfer, or technical operations
Proven experience in site transfers of approved ANDA / NDA products
Hands-on exposure to scale-up, exhibit batches, and process validation
Experience working with CMOs, preferably across geographies
Additional Notes
Strong understanding of solid oral / liquid dosage forms
Deep knowledge of USFDA regulatory expectations for post-approval changes and site transfers
Excellent documentation review and technical writing skills
Strong project management and stakeholder coordination skills
Ability to travel extensively and work hands-on at manufacturing sites
High level of ownership, decision-making, and problem-solving capability
