Demo

Validation Project Manager

SOKOL GxP Services
Summit, NJ Full Time
POSTED ON 2/12/2025
AVAILABLE BEFORE 5/2/2025

The Project Manager will develop project plans, develop, and manage timelines, and identify, and respond to critical path barriers. The role will require significant collaboration across internal and external functions to ensure on-time release of the final product. An Ideal candidate will have demonstrated ability to balance multiple competing priorities, and manage projects. The role is required to work in a cross-functional and dynamic setting where project assumptions and scenarios may change and therefore requires an individual who can quickly adapt to the changes and manage communications at different levels in the organization.

The work scope will include operations excellence, continuous improvement projects, and capacity expansion projects in support of commercial products. This role will work with project management and subject matter experts across multiple sites including Manufacturing, Operational Excellence, Supply Chain, MS&T, Quality Assurance, Quality Control, Process Development, CMC, TT lead, TCT lead, Global Engineering, Facilities Engineering, PMO, IT, EHS, Finance, Regulatory, and Clinical and Commercial Operations.

DUTIES AND RESPONSIBILITIES :

  • Manage multiple, low to medium complexity process improvement and / or technical projects and timelines.
  • Effectively manage team meetings, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow-up on action items.
  • Serve as a member of sub-teams, tracking timelines elements to ensure that functional deliverables are completed on time and according to relevant quality standards
  • Develop critical path analyses with the team to understand risks and opportunities within project timelines and help develop contingency plans
  • Responsible for the preparation of routine status reports and communicate project progress to stakeholders
  • Lead operational projects including weekly QC LIMS huddles, QC CTDO LIMS planning and management, and monitoring tools
  • Ensure that team recommendations related to project direction and timelines which need endorsement by governance teams are planned for review at appropriate milestones
  • Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
  • Develop and implement KPI and reporting capabilities
  • Collaborate with IT Business Partners in support of modeling, scheduling simulation implementations, and automated scheduling tools

EDUCATION :

  • Bachelor’s degree required in Science or Engineering
  • 5 years of relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.
  • PMP certification is strongly preferred.
  • Experience in biopharmaceutical clinical, supply chain, manufacturing, and commercialization.
  • QUALIFICATIONS :

  • Ability to work independently
  • Ability to matrix manage cross-functional teams
  • Must be competent in Project Management tools and methodologies
  • Excellent organizational and time management skills
  • Experience with regulated GMP environment for manufacturing (Biologics or Cell Therapy experience is a plus).
  • Strong analytical, problem-solving, and critical thinking skills
  • High attention to detail skills
  • High organization skills with the ability to multi-task several objectives in parallel
  • People and project management skills
  • Advanced proficiency in MS Office applications
  • Proficient written and verbal communication skills
  • Ability to develop and provide training on various functions
  • WORKING CONDITIONS :

  • This role may involve working in an office, laboratory, or manufacturing area.
  • Must be able to work in gowning attire within a controlled environment for extended periods.
  • Must demonstrate the ability to work safely with hazardous, radioactive, and biological materials and waste, ensuring safety both when working independently and with others.
  • Must be able to lift up to 15 pounds as needed.
  • What We Offer :

    Join SOKOL GxP Services! We partner with top pharmaceutical and biotech companies to deliver exceptional GxP and compliance services. At SOKOL, we’re dedicated to fostering diversity, supporting local talent, and building strong community connections to connect the best-qualified candidates with our clients. Be part of a dynamic team where you can shape the future of life sciences and advance your career in a collaborative, innovative environment. Our culture promotes growth and inclusivity, with a commitment to professional development and competitive benefits, including :

  • Health benefits
  • Holiday pay
  • Volunteer hours
  • Relocation assistance
  • 401K
  • program
  • Professional development opportunities
  • Employee referral program
  • Relocation support will be determined on a case-by-case basis.
  • Our 401K program is set to launch in the 2025 fiscal year.
  • How to Apply :

    https : / / www.sokolservices.com / open-positions

    All applicants will receive an acknowledgment that their application has been received within 2-3 weeks from the date of receipt.

    By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.

    Equal Opportunity Employer Statement :

    SOKOL GxP Services is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

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