Hikma Pharmaceuticals

Senior Project Manager – Technical Services

Hikma Pharmaceuticals

full-time

Posted on:

Location Type: Office

Location: ColumbusOhioUnited States

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About the role

  • Manages and delivers organizational and project leadership for Generic commercialization, Site Transfers, Buy-ins, Third Party, Alternate API, process changes (Quality & Product Robustness driven) and changes to Active Pharmaceutical Ingredients, Excipient, Packaging and Raw Material items.
  • Proactively identifies & manages risk which could adversely affect successful project completion.
  • Lead & facilitate multiple cross-functional team by managing and directing project team resources / experts to identify relevant issues and effectively manage progress and change.
  • Ensures integration of technical/commercial information and activities necessary to develop and support the success of the plan by utilizing project management skills/tools, including but not limited to, to successfully drive the project to meet established timelines: Project Plan Meeting Minutes/Agendas RAID log Costing assessments Meeting facilitation (Core & relevant sub-teams)
  • Assesses critical data and contributes information to identify / facilitate critical “Go / No Go” project decisions.
  • Provide proactive communication to all stakeholders, regarding issues, risks, contingency plans and potential negative impacts to the established milestones and timelines.
  • Be change leaders ensuring change management requirements are being facilitated i.e. Initial change notification assessment (SME assessment, cost evaluation, Master Change assessment) Management of Tactical and Strategic change meetings Creation of required Protocols (Change & Master Change) Creation of Qualification Technical Reports Management of CC’s in appropriate system Stage/Que/Monitor work in-progress Develop/Manage implementation plan Ensure Document review prior to final implementation
  • Assess completed projects for lessons learned to drive improvement in project performance/execution and capture data to drive/refine resource allocation/costing for future projects.
  • Mentor and develop other members of the Technical Services department.
  • Act as a subject matter expert on core technologies and/or project management topics (e.g. meeting facilitation, influence, risk management, etc.).
  • Lead knowledge sharing, individual skill development, and career development within the department, through sharing and implementation of best practices in both individual and group settings (e.g. 1:1 mentoring regarding a specific product/process challenge, and in PC meetings/staff meetings, respectively).
  • Identify and proactively create opportunities to mentor/job shadow with Junior Project Managers on specific equipment and process technologies (e.g. bringing Junior Project Managers to the shop floor during production and/or troubleshooting support), and on project problem solving (e.g. risk mitigation of various end to end supply chain trends of potential concern during peer review of a Junior Project Manager’s project, provide mentoring on recommend approaches for analysis and remediation, if needed).
  • Lead skill development of Junior Project Managers in the competency of Planning/Organizing, Critical Thinking, Problem Solving/Resolution, and Influence.

Requirements

  • B.S. degree in a scientific and/or related operations discipline plus a minimum of 9 years’ experience in pharmaceutical (multi-disciplinary experience: change management, analytical and/or drug regulatory affairs preferred) and/or project management.
  • Alternatively, a M.S. degree in a scientific and/or related operations discipline plus a minimum of 7 years’ experience in pharmaceutical (multi-disciplinary experience: change management, analytical and/or drug regulatory affairs preferred) and/or project management.
  • Minimum 9 years of industrial multi-disciplinary experience managing multiple, complex projects and/or implementing continuous improvement.
  • Expert knowledge and understanding of applicable regulations pertaining to the development and manufacturing of pharmaceuticals including cGMP, DEA, and FDA, EMEA.
  • Must possess knowledge of SOP’s, production processes and equipment and have strong understanding of pharmaceutical supply chain operations, business analysis, and pharmaceutical technology.
  • In addition, demonstrated knowledge of pharmaceutical development, scale-up and validation, and lifecycle processes.
  • Expert knowledge and understanding of project management methodology with an active PMP certification with the ability to effectively manage and partner with subordinates, peers, suppliers and contractors.
  • Demonstrated ability to deliver on results to meet determined business objectives/targets.
  • Demonstrated ability to communicate effectively (oral and written) both internally and externally at various levels locally, regionally & globally.
  • Demonstrated knowledge in continuous improvement methodologies and implementation with an active six-sigma certification preferred.
Benefits
  • Annual performance bonus, commission, and share potential
  • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
  • A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
  • 3 personal days (prorated based on hire date)
  • 11 company paid holidays
  • Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
  • Employee discount program
  • Wellbeing rewards program
  • Safety and Quality is a top organizational priority
  • Career advancement and growth opportunities
  • Tuition reimbursement
  • Paid maternity and parental leave
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
project managementchange managementrisk managementbusiness analysispharmaceutical developmentscale-upvalidationcontinuous improvementpharmaceutical technologysupply chain operations
Soft Skills
leadershipcommunicationmentoringcritical thinkingproblem solvinginfluenceorganizational skillsteam facilitationstakeholder managementdata assessment
Certifications
PMPsix-sigma