Project Manager- Delta V – Pharmaceutical Industry

USDM Life Sciences Overview

USDM Life Sciences provides a variety of IT and compliance solutions to help life sciences companies streamline laboratory, clinical and manufacturing operations while staying in compliance with FDA regulations. USDM disrupts convention and delivers compliance with proficiency, simplicity, and efficiency to achieve better results for our customers that are in the business of saving lives. It’s a place where you can make an impact in the world as a champion for life sciences innovation and also get the experience and mentoring to grow your career.

Founded in Santa Barbara, California in 1999 by two UCSB graduates, USDM has grown to a global company with offices throughout the US, Toronto, Canada and Frankfurt, Germany.

This position has overall responsibility for leading complex small capital projects or programs to successful completion. Responsible for effective project management of all major project phases: initiation, design, procurement, construction, commissioning, qualification and closeout. Assures that the capital investment is able to achieve functional, strategic, compliance and financial goals. Requires excellent internal and external collaboration and influencing skills and the ability to lead diverse, cross- functional teams in the successful delivery of projects. Typical project/program size ranges from $500k – $10M. Work is self-directed.

Job Responsibilities: W2 required. No Corp to Corp
 Responsible for leading small capital and expense projects for Project Delivery (PD).
Accountable for achieving project goals related to cost, schedule and scope.
 Ensures that capital delivery methodologies, project management processes/principles and
project management tools are consistently utilized to achieve project goals. Complies with Roche
Quality policies and U.S. Pharma Code of Conduct.
 Responsibilities include day-to-day project coordination, project management of project design
and execution according to cost, schedule, quality, safety and customer satisfaction objectives,
while ensuring compliance with local laws, technical rules and regulations.
 Ensures project planning and execution adheres to Engineering Manual Lite (EM Lite)
requirements, project management processes and principles. Ensures that project management tools are consistently utilized to achieve project goals and objectives and to deliver successful projects.
 Ability to collaborate with end-user and create clear user requirement specifications.
 Lead in the development of the project engineering plan and help coordinate review by relevant
functions.
 Run regular project team meetings, issue meeting agendas and minutes; maintain action item,
change and lessons learned logs.
 Develop project schedule and monitor progress against baseline timeline, communicate schedule
variances and critical path.
 Makes project related scope, cost and schedule decisions in consultation as appropriate with
project stakeholders and PD staff.
 Perform risk assessments. Escalate risks to PD and stakeholders, create mitigation plans.
 Effectively communicates with and influences all levels of the organization. Exercises excellent
judgment in determining appropriate project communications to internal and external stakeholders. Provides regular project status updates and presentations for senior management and the broader organization.
 Partners proactively with key customers and stakeholders (Manufacturing, MTS, Automation, Engineering, Facilities, Quality and Validation) to develop and execute capital projects that support business objectives.
 Partners proactively with other groups/functions (Finance, Procurement, Informatics, SHE, Planning, Legal, etc.) to meet project objectives, adhere to business processes impacting project planning/execution, and to implement business process changes.
 Provides strong project team leadership and champions project team collaboration. Influences and negotiates with project team members and project stakeholders to gain alignment and win concessions without damaging relationships.
 Ensure proper project documentation deliverables are identified and completed per project scope.
 Create and maintain organized project file systems for each project.
 Provide routine and ad hoc project status and performance information regarding assigned
projects, including monthly project reports
 Ensure project cost control and inform others on funding requirements. Review commitments
and expenditure for goods and services, including contractor, subcontractor, supplier, and consultant selection, as well as approval and control of any commitments charged to the project, including contracts, purchase orders, invoices, fees, travelling costs and expenses
 Keep key project customers, partners and other stakeholders aware of critical issues as these arise and seek assistance as necessary
 Develop project design flow based on specifics of project type, i.e. process, utility, automation
 Ensure appropriate consulting and provision of the necessary approvals of technical experts,
such as engineering, quality, environmental, health and safety, technology, etc.
 Support knowledge exchange within PD. Participate in lessons learned workshops during and
after handover of projects and integrate relevant input from previous projects
 Drives and promotes a culture of project management excellence in the organization. Supports
continuous improvement of project delivery practices.
 Ensures the integration of environmental health, safety, and security into the business
processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.
 Perform work in compliance with current Good Manufacturing Practice (cGMP) requirements and Roche corporate standards.
 Ensures assigned training requirements are current.

Job Requirements:
Education and Experience
 B.S. in Engineering (Chemical, Mechanical, Electrical preferred), Science or equivalent is
required.
 Minimum of 8 years experience successfully managing projects in the biotech/pharmaceutical
industry.
 Certification in project management (i.e. PMP certification) is highly desirable.
 Experience with capital projects, project controls, and project scheduling.
 Experience from a background of manufacturing, design or construction.
 Strong working knowledge of Microsoft based programs.

Disclaimer: This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

USDM Life Sciences is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran, disabled, or any other protected status.

Job Type: Contract

Experience:

• Delta V: 8 years (Required)
• Strong working knowledge of Microsoft based programs.: 1 year (Required)
• capital projects, project controls, and project scheduling.: 8 years (Required)
• managing projects in the biotech/pharmaceutical industry.: 8 years (Required)

Education:

• Bachelor’s (Required)

License:

• Project Management Professional (PMP) (Preferred)

Work authorization:

• United States (Required)