Project Manager - Capital Projects

KBI Biopharma•Boulder, CO

19h•$114,000 - $156,750

About The Position

The Project Manager, CAPEX is responsible for leading projects from requirements definition through deployment, identifying schedules, scopes, budget estimations, and implementation plans, including risk mitigation. They will perform the following objectives: Coordinate internal and external resources to ensure that projects adhere to scope, schedule, and budget. Analyze project status and, when necessary, revise the scope, schedule, or budget to ensure that project requirements can be met. Manage the CAPEX program for the site; to include cashflow forecasting, prioritization, commitments, tracking variances to budget, and facilitation of project governance. Establish and maintain relationships with relevant client stakeholders, providing day-to-day contact on project status and changes. Establish and maintain processes for managing scope during the project lifecycle, setting quality and performance standards, and assessing risks. Structure and manage integrated, multitrack performance databases for digital, print, social, broadcast, and experiential projects. Develop and maintain partnerships with third-party resources, including vendors and researchers. Assign and monitor resources to ensure project efficiency and maximize deliverables. Report project outcomes and/or risks to the appropriate management channels and escalate issues, as necessary, according to project work plan. Ensure alignment and coordinates with other functions such as Engineering, Validation, Maintenance, Manufacturing, MS&T, AFS, Process Development, and Quality Assurance. Supports efforts of the organization across functional boundaries. Provide technical decision-making regarding project implementation strategies as well as requirements for projects and change controls. Provide exceptional customer service to internal and external clients. Employee must have the ability to interface effectively with personnel across engineering, validation, maintenance, and other technical disciplines. Strong attention to deadlines and budgetary guidelines Proven success working with all levels of management. Strong written and verbal communication skills Excellent presentation skills Employee will actively manage a team of full-time employees and contractors. This includes the following: Ensuring adequate onboarding, support administration, and training for staff Providing managerial support for staff working in cross functional teams Providing technical guidance to ensure work is completed in a compliant and efficient manner. Ensuring adequate resource management to ensure projects are adequately staffed with trained team members and that staff can maintain work life balance. Facilitating staff development

Requirements

Minimum of Bachelor’s degree in an engineering, or biochemical engineering discipline
8+ years experience in the pharmaceutical/biotechnology field equivalent required
5+ years management experience
Minimum of 5 years project management
5 years GxP operations
Established knowledge of biopharmaceutical manufacturing, good engineering practices, and equipment design and qualification.
Strong technical writing and communication skills.
Proficiency with MS Project
Familiarity with MS Planner and Power BI
Ability to use negotiation skills drive to resolution on critical issues.
Ability to summarize issues and present to executive management.
A broad understanding of applicable codes and regulations.
Knowledge of Quality Systems and cGMP requirements for multiple regulatory jurisdictions (FDA, EU, ICH) and the ability to effectively evaluate and escalate risk is required.
Strong problem-solving capacity
Results orientation
Strong communication and presentation skills
Strong orientation for quality and customer service
High level of integrity and personal responsibility
Communication skills within all levels of an organization
Risk assessment and risk management
Project management including project delivery under aggressive timelines
Staff development and coaching

Nice To Haves

Background in Validation and Automation scope
PMP certification
LEAN / Six Sigma certification

Responsibilities

Lead projects from requirements definition through deployment, identifying schedules, scopes, budget estimations, and implementation plans, including risk mitigation.
Coordinate internal and external resources to ensure that projects adhere to scope, schedule, and budget.
Analyze project status and, when necessary, revise the scope, schedule, or budget to ensure that project requirements can be met.
Manage the CAPEX program for the site; to include cashflow forecasting, prioritization, commitments, tracking variances to budget, and facilitation of project governance.
Establish and maintain relationships with relevant client stakeholders, providing day-to-day contact on project status and changes.
Establish and maintain processes for managing scope during the project lifecycle, setting quality and performance standards, and assessing risks.
Structure and manage integrated, multitrack performance databases for digital, print, social, broadcast, and experiential projects.
Develop and maintain partnerships with third-party resources, including vendors and researchers.
Assign and monitor resources to ensure project efficiency and maximize deliverables.
Report project outcomes and/or risks to the appropriate management channels and escalate issues, as necessary, according to project work plan.
Ensure alignment and coordinates with other functions such as Engineering, Validation, Maintenance, Manufacturing, MS&T, AFS, Process Development, and Quality Assurance.
Supports efforts of the organization across functional boundaries.
Provide technical decision-making regarding project implementation strategies as well as requirements for projects and change controls.
Provide exceptional customer service to internal and external clients.
Ensure adequate onboarding, support administration, and training for staff.
Provide managerial support for staff working in cross functional teams.
Provide technical guidance to ensure work is completed in a compliant and efficient manner.
Ensure adequate resource management to ensure projects are adequately staffed with trained team members and that staff can maintain work life balance.
Facilitate staff development.