Job Description

CEL - External Manufacturing Project Manager
JobDiva # 21-01553

Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a CEL - External Manufacturing Project Manager for our client in Summit, NJ.  

Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:
  • Project Manager (PM) is responsible for the direction, coordination, implementation, control and completion of projects, while remaining aligned with company strategy, commitments and goals. PM oversees initiating, planning and executing Cell Therapy Development and Operations (CTDO) projects. The PM will report to the ExM/VPT lead and will be responsible for managing viral vector manufacturing operation related activities at CMO site(s). The PM will work with the cross-functional VPT and CMO stakeholders in developing and tracking plans supporting all activities at the CMO site(s) including but not limited to batch scheduling, deliverables supporting batch release, KPI measurement and special projects/initiatives. This position will also work closely with functional leadership and representatives to ensure alignment and coordination of CTDO priorities.
  • The PM will be responsible for using CTDO Project Management best practices, tools and templates. The successful candidate will collaborate with the CTDO Project Management organization to share ideas, tools, best practices, training, lessons learned, establish core competencies, conduct peer reviews of project management deliverables, etc.
  • The successful candidate must have the ability to work in a highly matrixed and cross-functional organization, against tight deadlines, and with world-class partners, suppliers and business leaders alike. The PM must have the drive to work with both internal and external partners to define and implement effective project management plans.

Responsibilities:
  • Partner with VPT and CMO team members to successfully achieve objectives
  • Provide strong team leadership and drive to ensure projects are executed on-time and within budget
  • Facilitate the definition of project scope, goals and deliverables
  • Create project plans; scope, work, resources, scheduling, etc.
  • Maintain project objectives through project lifecycle
  • Monitor execution and quality to customer/stakeholder/sponsor standards
  • Leverage technical, quality and regulatory SMEs to provide guidance to CMO(s)
  • Ensure cross-functional alignment on priorities and deliverables
  • Report on progress of manufacturing activities, offer viable solutions and opportunities as they arise
  • Implement appropriate project change control
  • Facilitate all project team meetings including recording of meeting minutes and follow-up action items
  • Coordinate activities to drive closure on action items
  • Manage and track CMO performance
  • Provide structure and leadership across departments to ensure team meets project objectives
  • Work with internal and external stakeholders to manage project deliverables, e.g. CMOs, Supply Chain, etc.
  • Manage continuous improvement initiatives to affect timely resolution of supply issues.
  • Develop and communicate status updates to internal and CMO stakeholders

Qualifications:
  • 3+ years experience in bio tech/life sciences project management
  • Experience in cellular or gene therapy is preferred
  • PMP certification and project management experience preferred
  • Proficiency with related software tools such as: MS Project, OnePager, SmartSheets, MS PPT, MS Excel, etc.
  • Working knowledge of biopharma industry
  • Experience in conflict resolution
  • Bachelors degree in Life Sciences-related discipline
  • Advanced degree in Life Sciences-related discipline and/or an MBA strongly preferred
  • Project management qualification; PMIs Project Management Professional (PMP) or equivalent preferred

Preferred Skills:
  • Ability to work cross-functionally, with matrixed teams; maintaining strong business partner relationships
  • Strong communication skills
  • Excellent interpersonal, communication, and presentation skills
  • Excellent problem-solving skills
  • Willingness to do what needs to be done in a dynamic environment

If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

If interested, you may contact:
 
John Bayog
John.Bayog@eclaro.com
6466952925
John Bayog | LinkedIn


Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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