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Product Development Scientist Jobs in New Jersey

Global Product Development and Supply Project Manager # 26-27774

US Tech Solutions, Inc.

  • New Brunswick, NJ
  • 1 day ago

    Highlights

    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. 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.

    Numbers & Facts

    LocationNew Brunswick, NJ

    Description

    Duration:12 months(High possibility of extension for the right candidate depending on performance)

    Job Description:

    Must Haves:
    • Required Bachelor's degree
    • 3+ years’ experience in a GMP environment
    • 3+years’ experience with clinical trial or packaging/labeling experience
    • 3+ years with MS Office 365
    • Strong written communication skills
    • Experience in ERP systems e.g. SAP
    Position Description:
    • 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. 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.
    • Participate in assigned training including CGMP and safety training.
    • Authors and reviews procedural documents.
    Education:
    • Required Bachelor’s 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.
    Note:
    • 50% onsite required
    • Work Schedule: Mon-Fri(normal business hours)

    About US Tech Solutions:
    US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

    US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.

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