Operations Project Manager Jobs in New Jersey

POSITION SUMMARY

The Project Manager – Integrator & Expeditor -- 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, clean-room 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 on-boarding.
• 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 inter-dependencies.
• Consolidate progress updates and ensure adherence to contractual milestones and performance indicators.

EXPEDITING & RISK MANAGEMENT

• 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 & 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 hand-offs, deliverables, and readiness checkpoints.

CLIENT & INTERNAL COMMUNICATION

• Serve as the primary point of contact for clients; manage program changes and ensure clear documentation.
• Provide executive-level updates on project performance, risks, and acceleration opportunities.
• Lead weekly project stand-ups, cross-functional syncs, and steering committee reviews.
• Host client audits and site visits, ensuring transparency and confidence in project progress.

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.

KEY BENEFITS AND IMPACT

• Strong leadership and communication skills with ability to influence across functions and organizations.
• Skilled in risk management, problem-solving, and decision-making under pressure.
• Demonstrated ability to manage multiple client programs in a CDMO environment.
• Collaborative team player with client-first mindset and ability to foster trust.
• Highly organized, proactive, and results-oriented with a bias for action.
• Accelerates facility readiness and client on-boarding.
• Prevents costly delays from supplier misalignment.
• Enables early revenue capture by compressing timelines.
• Enhances CDMO competitiveness by ensuring reliable, high-quality delivery of sterile operations

POSITION QUALIFICATIONS

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:

• Bachelor’s degree in engineering, Pharmacy, Biotechnology, or related discipline.
• Proficiency in Microsoft Office, Smartsheet and other project management software

Job Type: Temporary

Pay: $70.00 per hour

Work Location: In person