Project Manager

**Job Description:

**

The PMO Project Manager is the project leader for multidisciplinary project teams providing direction, drive, coordination and support for the successful initiation, planning, execution, monitoring and closing of contract manufacturing initiatives.

The PMO Sr. Project Manager is a certified Project Management Professional (PMP) who is the project leader for multidisciplinary project teams providing direction, drive, coordination and support for the successful initiation, planning, execution, monitoring and closing of contract manufacturing initiatives.

• Comply with HS Project Management Guideline directives.

• Provide project leadership, coordination and support for multidisciplinary contract manufacturing teams.

• Mentor / direct Associate Project Managers.

• Ensure projects are kicked off appropriately and required technical transfer information has been delivered by the client.

• Ensure that a project schedule encompassing project scope and associated details is accurately developed and regularly maintained.

• Ensure equipment and components are identified and purchased in a timely manner.

• Ensure effective communication of project timelines, status and needs to all project team members and stakeholders typically per weekly teleconferences and associated meeting minutes.

• Communicate timeline and scope change concerns to HollisterStier Business Development and management.

• Monitor and report on component purchases, validation activities, process transfers, analytical transfers, and inspection, packaging and shipping requirements.

• Ensure daily communication of operational status and issues to affected staff and next higher level management.

• Ensure timely review and updates of manufacturing, validation and other documentation associated with the project.

• Verify manufacturing personnel are properly trained prior to project execution.

• Analyze and make recommendations regarding Project Management improvements.

• Interact with Quality Assurance and Maintenance departments to ensure production issues are dealt with promptly and with appropriate quality input.

• Ensure required activities are scheduled including equipment / component machinability runs, process walk throughs, demonstration and production runs and validation of processes and equipment.

• Ensure that Manufacturing has the required components, manufacturing documentation, and training prior to the manufacture of any batches.

• Meet and maintain requirements for GMP manufacturing and comply with GMP guidelines.

• Accompany client in plant throughout process.

**Sr. Project Manager *In addition to above*: **

• Recommend and contribute to process and system improvements.

**

Qualifications:**

• Bachelor of Arts or Science, with a Hard Sciences/Engineering Major Required. OR 10 years of related experience in lieu of degree. HS diploma still required.

• Project Management specific coursework desired.

• 2 years minimum related experience in Project Management Experience required

• 5-10 years related experience desired.

• Supervisory experience desired

• 2 years minimum experience in FDA Regulated Industry & Pharmaceuticals required.

• Experience in Microsoft Word Required

• Experience in Excel, PowerPoint & Microsoft Project desired.

• Ability to manage conflict and influencing outcomes, continue client/team interactions required.

• Experience in

  Working in Aseptic Areas desired

• Ability to sit and stand for prolonged periods required

• Cleanroom environment experience desired.

**Sr. Project Manager Qualifications: *(in addition to above)* **

• Certifications: Project Management Professional (PMP) certification through Project Management Institute

• 5 years of project management experience may temporarily substitute in lieu of certification, however certification must occur within 1 year.

• Project Management Professional required.

• Minimum of 3 years of related experience in Project Management

• 3 years minimum experience in FDA Regulated Industry & Pharmaceuticals required.

• Experience in Microsoft Word, Excel, PowerPoint & Microsoft Project Required

• Mechanical Aptitude desired.

You should be proficient in:

• Bachelor's Degree
• Project Management
• FDA Regulations
• Pharmaceuticals

ID:8SR6Ct