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IT Project Manager

Employer
Paragon Gene Therapy, a unit of Catalent Biologics
Location
Harmans, MD, US
Start date
May 3, 2019

View more

Discipline
Information Technology, Project/Program Management
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital

Job Details

Paragon Bioservices is a contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. We provide industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Paragon's scientists, engineers, quality experts, manufacturing operators and program managers are experts working with biologics from research and process development to GMP manufacturing for clinical trials and commercial launch.

We have an exciting opportunity for an experienced IT Project manager looking to develop their skills with a fast-growing Biotech company. This position will closely interface with Finance, Process Development, Manufacturing, Quality Assurance, Quality Control, and Project Management to ensure that all Manufacturing requirements are met and on-schedule. The role will report to the Paragon IT Program Manager in support of our capital project initiatives.

Key Responsibilities include but are not limited to:

  • Establish and maintain the Project WBS (Work Breakdown Structure) & Budget during the Project Concept Phase and maintain during the life of the projects.
  • Proven skills and experience delivering, managing and controlling large IT projects in a biotechnology environment.
  • Lead projects such as platform installations, upgrades and migrations, and data extracts for financial or audit purposes.
  • Experience of working with internal delivery teams
  • Works with end users on all functional modules to document business needs and/or requirements for upgrades and enhancements
  • Established, manage and communicate the means identify, document, escalate, and track Outstanding Project Issues.
  • Support the Program and Projects' Communications Plans
  • Establish and support the methods to identify, document, scope, approve, and track Change Requests.
  • Support the development of the Stage Review Presentations in partnership with the Program Manager.

Skills & technical expertise:

  • Proven record of strong project management and/or program management proficiency, with an emphasis on GMP systems installation and validation, IT System Development Life Cycle, and Change Control methodologies and processes.
  • Experience in deploying GMP Cloud based systems preferred.
  • Excellent knowledge of application architectures and business process improvement techniques.
  • Demonstrated success in building strong relationships across client organizations and vendors.
  • Demonstrated ability to analyze and define project problems early and identify appropriate means to address with the team
  • Ability to closely manage to a dynamic budget is essential.
  • Strong analytical, problem solving, and communication skills.
  • Intermediate/Advanced knowledge of Microsoft Office products.

Education & Experience:

  • Bachelor degree in a business or IT field required
  • 5 years experience in an IT &/or Project Management role.
  • Proven record of successful realization of ERP or QMS solutions.
  • Excellent understanding of cGMP's and System Development Life Cycle methodologies.
  • Excellent facilitation, problem solving, and communications skills.
  • Working knowledge of the regulatory requirements for pharmaceutical applications
  • Understanding of ITIL support methodologies.
  • Experience in supporting Enterprise platforms in a GXP environment.
  • Demonstrated understanding of quality and compliance

Desired:

  • Proven facilitation, meeting/workshop management, project management and change management skills.
  • A sense of ownership and enterprise leadership to delivery high quality solutions that solve business problems


Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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Company

Company info
Location
801 West Baltimore Street
Suite 302
Baltimore
Maryland
21201
US

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