Project Manager

Spectraforce Technologies; New Brunswick (NJ); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Spectraforce Technologies, Inc. seeks a Project Manager to lead clinical supplies projects in a hybrid New Brunswick, NJ setting. Manages packaging, labeling, scheduling, and vendor coordination to ensure on-time delivery and regulatory compliance. The role emphasizes SAP, GMP, and cross-functional collaboration.

Qualifications

• Bachelor's degree or equivalent in pharmacy, engineering, business or life sciences.
• 5-7 years of relevant pharmaceutical or healthcare experience; clinical experience preferred.

Responsibilities

• Develops detailed time and event schedules; coordinates deliverables and milestones.
• Generates packaging/BOMs and production orders in SAP; ensures order accuracy.
• Executes SAP transactions (goods receipt/consumption); manages BOM structures and process orders.
• Reviews vendor proofs and production orders; approves related documents.
• Ensures CGMP/compliance; reports deviations to management and QA.
• Works cross-functionally with project teams.
• Identifies opportunities for process improvement.
• Participates in CGMP and safety training; authors and reviews procedures.

Skills

Project management

Cross-functional collaboration

GMP experience

Communication skills

ERP/MRP knowledge

Scheduling and planning

Education

Bachelor's degree in pharmacy, engineering, business or life sciences

Tools

SAP

Job description

Position Title: Project Manager
Duration: 12 Months - High possibility of extension for the right candidate depending on performance
Work Location: New Brunswick, NJ 08901
Work Arrangement: Hybrid - 50% onsite required
Work Schedule: Monday-Friday (normal business hours)

Position Summary

Supports delivery of clinical supplies through effective management of assigned projects. Manages multiple projects.

Liaise with responsible Trial Supply on aspects of clinical supplies packaging and labelling design and study requirements. Ensures production schedules meet agreed upon on-time delivery date of finished supplies.

Key Responsibilities

- Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects. Responsible for coordinating availability of all deliverables (e.g. drug product and components, randomization file and label text).

- Generates internal packaging and labeling bill of materials and productions orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects. Responsible for the creation and/or release of Bill of Materials and process orders in SAP for assigned projects, including relevant checks on order accuracy.

- Executes all required SAP transactions such as goods receipt and goods consumption. Assures Bill of Material structures are consistent with the requirements of Independent Requirement Order (IRO) and Packaging Specification (PS). Converts planned orders (print and production) into process orders completing all required user fields and adding long text as required. Executes TECO transaction on completed process orders. Compiles supporting documentation and delivers a body of evidence (batch records) that supports the release of finished supplies for clinical use. Liaises with Quality Assurance to secure release of finished supplies.

- Reviews and approves vendor generated label proofs, orders specifications and other related documents. Reviews and approves vendor generated production orders and other related documents (i.e. change orders).

- Ensures regulatory and CGMP compliance of activities in assigned areas of responsibility, through monitoring and management of performance and reporting any deviations immediately to the appropriate management and Quality unit. May enter change controls and deviations into quality management system and conduct investigations as assigned.

- Works cross-functionally with individuals and project teams in various areas.

- Identifies opportunities for improving business processes and/or participates on project teams that are focused on continuous improvement.

- Participates in assigned training including CGMP and safety training.

- Authors and reviews procedural documents.

Qualification & Experience

- Required Bachelors degree or equivalent in pharmacy, engineering, business or life sciences .

- 5- 7 years relevant experience in the pharmaceutical industry or related healthcare environment. Highly prefer in Clinical

Competencies Required

• Demonstrates ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment.
• GMP and/or clinical trial experience highly preferred
• Strong project management skills.
• Possesses solid oral and written communication skills.
• Good decision making and organizational skills.
• Demonstrates ability to effectively communicate ideas and to influence others to achieve results.
• Knowledge of ERP/MRP systems and supply chain principles.
• Eager to learn and continuously improve.