Project Manager II

Job Summary:

This position is a full-time (non-classified), project management-level position at the Gates Institute located on the Anschutz Medical Campus and serves on the Program Management Office (PMO) team. This position will guide and drive technical and manufacturing project teams in achieving specific project objectives, facilitate client relations, develop project plans, and ensure clear communication between the client, team members, management, and other interested parties.

As a member of the PMO team, the Project Manager will lead efforts in tracking costs and progress against project milestones, and is responsible for building and maintaining strong, impactful relationships with internal and/or external clients, and working cross-functionally and collaboratively with technical, operations, quality, and business groups to effectively integrate processes, knowledge, tools, and personnel. This role must guide, influence, and collaborate using sound leadership skills.

This position involves responsibility for procuring all federal approvals of drug submissions pertaining to chemistry and manufacturing. This role is responsible for assuring that activities related to the entrance of a new drug or medical device into the market are compliant with the Food and Drugs Act and Regulations. This position bridges the gap between the business aspects of project management and the scientific aspects of moving a product from research to market, all while complying with regulations and laws related to biomanufacturing.

Key Responsibilities:

• Provides guidance and mentorship to project team members and ensures that the project team is working efficiently according to project objectives, goals, specifications, deliverables, and timelines.

• Manages the Statement of Work (SOW) creation and approval process for assigned projects.

• Generates project plans including but not limited to milestones, hours, schedules, communications, risk analysis.

• Prepares and leads kick-off and regular project team meetings internally and with clients.

• Ensures the required manufacturing, quality, and regulatory documents, labels, and sampling plans are identified, resourced, created, and completed according to schedule.

• Leads project teams in prioritization of tasks, and technical and logistical problem-solving issues affecting schedule, cost, and quality.

Initiates and maintains client information in the ERP system and RFP and SOW tools.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.

Why Join Us:

The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly dedicated people, operating on a top tier research campus - the University of Colorado - Anschutz Medical Campus.

The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. We are only limited by our resources and need you to make our journey a success!

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options

• Dental: Multiple plan options

• Additional Insurance: Disability, Life, Vision

• Retirement 401(a) Plan: Employer contributes 10% of your gross pay

• Paid Time Off: Accruals over the year

• Vacation Days: 22/year (maximum accrual 352 hours)

• Sick Days: 15/year (unlimited maximum accrual)

• Holiday Days: 10/year

• Tuition Benefit: Employees have access to this benefit on all CU campuses

• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

• A bachelor's degree in physical or natural sciences, project management, engineering or a directly related field from an accredited institution.

  • A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year for year basis.

• 4 years of professional level experience in project management of biomanufacturing, pharmaceutical manufacturing, or equivalent.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• CAPM or PMP

• Master's degree in a related field from an accredited college or university.

• Experience in Biomanufacturing, Pharmaceutical, or Device manufacturing, or other highly regulated industry.

• Experience working in an academic institution.

Knowledge, Skills and Abilities:

• Exceptional knowledge of project management process, skills, and tools.

• Strong critical thinking and problem-solving skills required.

• Exceptional multi-tasking and organizational skills, as well as the ability to make complex decisions in a fast-paced environment.

• Knowledge of and the ability to work with the MRP System (Microsoft Dynamics/Great Plains).

• Knowledge of GDP, GLP, GMP, CMC, and classified clean room practices/requirements.

• Basic knowledge of protein production and/or cell therapy processes

• A strong understanding in drug development processes.

• Knowledge of Food and Drugs Act and Regulations and other important rules and laws related to drugs, with the ability to explain these regulations to team members.

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to the listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Vanessa McWhirt at vanessa.mcwhirt@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until October 24, 2025

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $65,894 - $83,817.

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.