Senior PM - Genentech/Roche South San Fran, CA (Pipeline)

Kelly Science and Clinical FSP is currently seeking a Sr. Project Manager for a long-term engagement with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time

Senior Project Manager - Capital Investment Projects - Consultant

The Position
Responsible for complete Project Management (personnel & processes) for the site processes in the assigned area for a new facility/production line. Manages all aspects of the Project from conception through completion within scope, cost, quality & schedule requirements. Leads & manages the Project Management team so that stated project objectives & solution requirements are met in compliance with company procedures & standards.

Relationships
Reports to Project Director or Site Vice President.

Essential Functions

• Responsible for defining overall scope, establishing detailed RFP for obtaining proposals from all required consultants (engineering, construction, cost estimations (IPC costs), equipment vendors, etc.)
• Ability to create detailed business case, & present to senior management within NN & IPG for funding of project
• Effectively organize & manage multi-disciplined project team to ensure successful completion of all project deliverables - including hiring, goal setting, performance management, employee development & engagement
• Manage major milestones, schedules & monthly cost plans through the Clarity & PEM processes
• Provide periodic project status to STC including risks/mitigations, financial updates, short/long term project outlook, etc.
• Responsible for managing project change control to ensure project remains within defined scope, budget & schedule
• Extensive collaboration with other sites within NN & external stakeholders to gain best practices & equipment specifications
• Responsible for adherence to mechanisms for monitoring project progress, intervention & problem solving with other line managers or personnel
• Assist with any training required of personnel supporting the project
• Ensure all facets of the project lifecycle align with expectations set forth by the STG &/or project owner, such as installation, troubleshooting, qualification & validation of equipment
• Lead, & coach Subject Matter Experts (SMEs) to ensure a high performing collaborative team environment
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Physical Requirements
Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)

Qualifications

• Bachelor's Degree in Engineering, Economics, Business Administration, or other relevant disciplines from an accredited university (required).
  • Minimum of nine (9) years proven leadership & project management in a manufacturing facility, including :
  • Capital Investment Projects with major projects more than $20M required
  • Advanced Project Management competencies obtained through relevant PM training or experience preferred
  • Minimum of five (5) years of experience in pharmaceutical or biotechnology environment preferred
• Required experience:
  • Product/Process Transfer Projects
  • Change Management Projects
• Preferred Experience and Skills experience:
  • Knowledgeable in core work processes & GMP concepts
  • Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts
  • Demonstrates functional/business understanding as well as superior written & oral communication skills preferred
  • Extensive knowledge of project management including the ability to create work plans & detailed project schedules preferred
  • Proficient in problem solving, negotiation, conflict management & interpersonal skills preferred
  • Ability to act as project lead & lead cross functional project teams in the development & implementation of projects preferred
  • Ability to influence others on objectives & projects outcomes preferred
  • Basic understanding of contractual documents preferred
  • Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC & Electrical systems preferred
  • Thorough understanding of technical documents such as URS, SAT, FAT & Validation Protocols preferred
  • Proven project management experience with direct management of multiple projects simultaneously preferred
  • Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems preferred
  • Initiative & ability to function independently or within a team preferred
  • Good judgment in decision making as well as good leadership skills preferred