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8 Sep 2020

Full-Time Project Manager

Civica RX – Posted by Estincelli Lehi, Utah, United States

Job Description

Reporting to the Chief Manufacturing and Supply Chain Officer, the Project Manager will support implementation of autonomous manufacturing initiatives for Civica.  This includes tracking/coordinating end-to-end activities from development through regulatory submission and approval ANDA products being developed for Civica, technical transfer and qualification of captive capacity for commercial manufacture of Civica products and product launches.  This role also involves management of projects for potential acquisitions of Civica manufacturing sites and/or operations, development of Civica-owned packaging operations / distribution center(s), and related projects, as required.


Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

  • Manage multi-functional and technical project teams to implement manufacturing facility and equipment projects for sterile injectable drugs. Projects may include product development, technical transfer, process qualifications/validations, facility construction, manufacturing capacity expansion, process equipment improvements, process scale-up and technical process improvements, contract manufacturing, efficiency improvements, and miscellaneous technical and project planning support.
  • Development and tracking of detailed project plans.
  • Manage project costs and report on project financials.
  • Provide project risk management oversight.
  • Routine reporting to team members, management and others.
  • Directs project(s) and project teams ensuring all necessary activities occur as planned.
  • Coordinate scheduling of project activities to meet deliverables.
  • Utilize expertise and experience to resolve issues.
  • Identify resource issues and utilize effective communication/leadership to ensure that satisfactory resolution occurs.
  • Maintain close contact with both Civica and external partner representative(s) through meetings, site visits, teleconferences, and other forums to ensure that issues are addressed and project timeline activities are met.
  • Serves as primary contact and communication link between Civica and external project partners and companies.
  • Meet regularly with project team members to understand technical, quality and financial issues as related to the project(s).
  • Prepare and present project updates to Civica executive and advisory committees, as necessary.
  • Solicit other projects that are aligned with Civica goals & objectives.
  • Perform other duties as assigned.


Minimum Qualifications (Knowledge, Skills, and Abilities)

  • 8-20 years of experience in the pharmaceutical manufacturing and GMP facility.
  • 3+ years of project management experience in the pharmaceutical industry relating to product development and launch, business process optimization, regulatory submission and/or regulatory compliance, and/or quality assurance.
  • BS /BA in a relevant discipline, e.g. project management, engineering, R&D, operations management, or similar is required.
  • Experience in pharmaceutical operations/cGMP environment.
  • Knowledge and application of a disciplined project management process (Six Sigma and Project Management Professional certifications a plus)
  • Ability to work with a variety of technical disciplines.
  • Knowledge of and significant proficiency in project management software, such as Microsoft Project and others.
  • Solid analytical and strategic capabilities and business acumen along with demonstrated work ethic, integrity, and professional conduct.
  • Demonstrated ability to effectively communicate and negotiate a diversity of issues.
  • Strong interpersonal and communication skills, both verbally and written, at all levels within Civica and external partner organizations.
  • Ability to effectively collaborate with others to achieve team goals and expectations.
  • Effective time management and prioritization skills.
  • Outstanding organization skills and attention to detail.
  • Self-starter, mature, independent and dependable.
  • Ability to work in a fast-paced environment under pressure, able to multi-task and obtain results.
  • Ability to maintain high degree of confidentiality and use of appropriate discretion and independent judgment.

How to Apply

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: 100,000 and above.

Job expires in 28 days.

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