Project Manager

Dexian; Middlesex (NJ); Híbrido; USD 69.000 - 73.000; Tempo integral

Resumo da vaga

Dexian is seeking a Clinical Supply Project Manager in New Brunswick, NJ to plan, coordinate, and execute clinical supply projects in a GMP-regulated environment.

The role requires strong project management, SAP expertise, and cross-functional collaboration across QA, manufacturing, and supply chain to ensure timely delivery of clinical materials. This contract position offers hybrid work with 50% onsite.

Qualificações

• Bachelor's degree in Pharmacy, Engineering, Business, Life Sciences, or related discipline.
• 5–7 years of pharma/healthcare experience.
• Experience managing multiple projects and deliverables.
• Knowledge of pharmaceutical supply chain, production planning, ERP/MRP.
• Hands-on SAP experience with BOMs, production orders, and transactions.
• Strong organizational, communication, and PM skills.
• Ability to manage competing priorities in a fast-paced environment.
• Problem-solving and decision-making abilities.

Responsabilidades

• Manage multiple clinical supply projects to meet timelines.
• Develop and maintain detailed project schedules and track milestones.
• Coordinate packaging and labeling with stakeholders.
• Ensure availability of materials, drug products, packaging components, and labels.
• Create BOMs and production orders in SAP.
• Execute SAP transactions: goods receipt, goods consumption, production order management.
• Review BOM structures, production specs, and process orders for accuracy.
• Compile batch records and documentation for release.
• Collaborate with QA to release finished products for clinical use.
• Review vendor label proofs, production orders, specs, and changes.
• Ensure activity compliance with GMP/CGMP.
• Support deviation reporting, change controls, and quality investigations.
• Collaborate with cross-functional teams and vendors to resolve issues.
• Identify opportunities for process improvements.
• Draft and maintain procedural documentation; participate in training.

Conhecimentos

Project management

Prioritization

Problem solving

Communication skills

Organizational skills

Formação

Bachelor's degree in Pharmacy, Engineering, Business, Life Sciences, or related discipline

Ferramentas

SAP

Descrição da vaga

Job Title: Clinical Supply Project Manager

Location: New Brunswick, NJ
Employment Type: Contract
Duration: 12+ Months
Pay range: $50-$53/hr on W2
Work Arrangement: Hybrid - 50% onsite
Work Schedule: Monday-Friday, Normal Business Hours

Position Summary

We are seeking an experienced Clinical Supply Project Manager to support the planning, coordination, and execution of clinical supply projects within a pharmaceutical environment. This individual will manage multiple projects, coordinate clinical packaging and labeling activities, oversee production schedules, and ensure timely delivery of finished clinical supplies.

The ideal candidate will have experience in pharmaceutical operations, clinical trial supply management, SAP, and GMP-regulated environments, along with strong project management and cross-functional coordination skills.

Key Responsibilities

• Manage multiple clinical supply projects, ensuring activities and deliverables are completed within established timelines.
• Develop and maintain detailed project schedules, track milestones, and monitor production activities to ensure on-time delivery.
• Coordinate clinical trial packaging and labeling requirements with internal stakeholders.
• Ensure availability of required materials, drug products, packaging components, randomization files, and label text.
• Create and manage Bills of Materials (BOMs) and production/process orders in SAP.
• Execute SAP transactions, including goods receipt, goods consumption, and production order management.
• Review BOM structures, production specifications, and process orders for accuracy and compliance.
• Compile batch records and supporting documentation required for the release of finished clinical supplies.
• Collaborate with Quality Assurance teams to facilitate the release of finished products for clinical use.
• Review vendor-generated label proofs, production orders, specifications, and change-related documentation.
• Ensure activities comply with applicable regulatory requirements and GMP/CGMP standards.
• Support deviation reporting, change controls, and quality investigations as assigned.
• Collaborate with cross-functional teams, vendors, and stakeholders to resolve project-related challenges.
• Identify opportunities for process improvements and contribute to continuous improvement initiatives.
• Author, review, and maintain procedural documentation and participate in required compliance and safety training.

Required Qualifications

• Bachelor's degree in Pharmacy, Engineering, Business, Life Sciences, or a related discipline.
• 5-7 years of relevant experience in the pharmaceutical industry or a related healthcare environment.
• Experience managing multiple projects and coordinating critical deliverables.
• Knowledge of pharmaceutical supply chain, production planning, and ERP/MRP systems.
• Hands-on experience with SAP, including BOMs, production orders, and related transactions.
• Strong organizational, communication, and project management skills.
• Ability to manage competing priorities and meet deadlines in a fast-paced environment.
• Strong problem-solving and decision-making abilities.

Preferred Qualifications

• Experience in clinical trial supply operations.
• Background in clinical packaging and labeling.
• Knowledge of GMP/CGMP regulations and pharmaceutical quality systems.
• Experience with batch documentation, QA release processes, deviations, and change controls.
• Experience coordinating with external vendors and cross-functional pharmaceutical teams.

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority‑owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting‑edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory‑changing results that help everyone achieve their ambitions and goals.To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.