Project Manager Sterile Operations
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Job Location:
Morristown, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
The Project Manager - Sterile Operations will lead the design integration and execution of a new sterile
injectable CDMO business unit within an existing facility. This role will serve as the central orchestrator
across internal stakeholders and external suppliers ensuring timely delivery of equipment cleanroom
construction qualification and GMP readiness.
In addition the Project Manager will oversee client-driven drug development and technical transfer
projects (sterile liquids oral and topical dosage forms) managing programs from feasibility through
pre-commercialization. The successful candidate will combine strong sterile operations knowledge
advanced project management skills and the ability to align diverse stakeholders to accelerate
execution mitigate risk and enable early revenue generation.
KEY RESPONSIBILITIES
Integrated Project Timeline & Execution
* Develop and maintain a master integrated project schedule covering facility build equipment
delivery qualification and client onboarding.
* Establishes governance work breakdown structures and resource plans for all project phases.
* Track deliverables across URS DQ FAT/SAT IQ/OQ/PQ SOPs and training documentation.
* Identify and manage critical path activities and interdependencies.
* Consolidate progress updates and ensure adherence to contractual milestones and performance
indicators.
* Monitor and expedite critical path items including equipment delivery FAT/SAT documentation
and site readiness.
* Maintain RAG dashboards to track project health and escalate risks.
* Proactively identify blockers develop recovery plans and ensure client milestones are met.
* Ensure deliverables are recorded and tracked in business systems for billing and revenue
forecasting.
Vendor and Stakeholder Coordination
* Serve as the primary liaison between contractors suppliers and internal teams.
* Coordinate activities with major vendors including IPS (design) Mecart (construction) SKAN
(isolator)
Groninger (filler) Meco (utilities) Steris (VHP/autoclave) and internal
validation/QA/engineering teams.
* Align all parties on handoffs deliverables and readiness checkpoints.
Drug Development & Tech Transfer
* Manage client product development and tech transfer projects from feasibility through pre
commercialization.
* Work closely with Analytical Development QA and Manufacturing to ensure seamless scale-up and
commercialization.
* Balance multiple client programs ensuring timelines budgets and regulatory requirements are
met.
EXPERIENCE:
* 7 years in pharmaceutical or biopharma operations with direct exposure to sterile manufacturing
and facility builds.
* 3 years in multi-vendor project integration capital project execution or CQV coordination.
* Proven ability to lead complex cross-functional projects under aggressive timelines..
* Strong working knowledge of CGMP 21 CFR 210/211/820 Annex 1 and validation lifecycle.
* Proficiency with project management tools like MS Project Smartsheet Primavera or equivalent
Preferred:
* Experience working with sterile vendor partners: IPS Mecart SKAN Steris Meco Groninger.
* Knowledge of drug-device combination product requirements including design control and DHF
alignment.
* PMP certification Or Agile Project Manager
* Familiar with ISO 13485
EDUCATION:
* Bachelors degree in engineering Pharmacy Biotechnology or related discipline.
* Proficiency in Microsoft Office Smartsheet and other project management software
Required Experience:
IC
Key Skills
- Six Sigma
- Lean
- Management Experience
- Process Improvement
- Microsoft Outlook
- Analysis Skills
- Warehouse Management System
- Operations Management
- Kaizen
- Leadership Experience
- Supervising Experience
- Retail Management
About Company
Synerfac Staffing Employment Agencies are located across the U.S. for your convenience. Synerfac specializes in accounting, administrative, engineering, IT skilled trades, scientific, sales staffing and more.
