Project Manager, Pharma Engineer, Pharmaceutical Manufacturing

Job Title :
Project Manager – Sterile Injectable Tech Transfer

Location :
New Jersey

Employment Type

:
Contract (W2 / 1099)

Duration : 12 Months

We are seeking an experienced Project Manager to lead sterile injectable technical transfer programs within a pharmaceutical manufacturing environment. This individual will serve as the primary point of contact for customers and internal stakeholders while managing multiple tech transfer projects from initiation through commercialization.

The ideal candidate will have a proven track record leading the transfer of commercially approved sterile injectable products and possess strong expertise in aseptic manufacturing, validation, PPQ execution, and cross-functional project leadership.

• Independently manage multiple sterile injectable technical transfer projects from initiation through completion
• Serve as the primary customer-facing representative for assigned technical transfer programs
• Develop, maintain, and execute comprehensive Technical Transfer Plans
• Create and manage detailed Work Breakdown Structures (WBS), project schedules, and execution timelines
• Lead cross-functional teams including Manufacturing, MS&T, Quality, Regulatory, Validation, Engineering, Supply Chain, and Operations
• Conduct project risk assessments, gap assessments, and develop mitigation strategies
• Manage change control activities associated with technical transfer projects
• Monitor project scope, timelines, deliverables, and risks while ensuring alignment with customer expectations and business objectives
• Facilitate project meetings, stakeholder communications, and action item tracking
• Escalate and resolve project risks and issues in a timely manner
• Ensure project documentation is complete, compliant, and audit-ready
• Support transfer readiness activities, process validation, PPQ execution, and commercialization efforts

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related field
• 5+ years of experience in sterile injectable pharmaceutical manufacturing, MS&T, Technical Operations, or related functions
• 3+ years of direct experience leading sterile injectable technical transfer projects
• Experience transferring commercially approved sterile injectable products
• Experience with vials, pre-filled syringes, and/or pre-filled cartridge products
• Strong understanding of aseptic processing, sterile manufacturing operations, validation, PPQ, and change control
• Experience developing and managing Technical Transfer Plans
• Experience creating and managing WBS, project schedules, timelines, risk assessments, and execution plans
• Experience supporting process validation, PPQ execution, and commercialization activities
• Ability to independently manage multiple complex cross-functional projects
• Strong stakeholder management and communication skills
• Advanced Smartsheet experience

• Experience working within CDMO environments
• Experience managing global technical transfer programs
• Knowledge of regulatory requirements associated with sterile injectable products

Compensation is based on experience.

This is a contract position and does not include employer-provided benefits.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background checks may be conducted in accordance with applicable laws.

Work Authorization

Applicants must be authorized to work in the United States.