Colorado Anschutz
Biomanufacturing Project Manager III
Colorado Anschutz, Aurora, Colorado, United States, 80010
Biomanufacturing Project Manager III
University of Colorado Anschutz Medical Campus Department: Gates Institute Biomanufacturing Facility Job Title: Biomanufacturing Project Manager III Position #: 00837358
Requisition #:37355 Job Summary
This University Staff (non-classified) position will coordinate and schedule client projects, control document approval, and directly lead/coordinate project managers for technical project teams. This management position will oversee the achievement of overall and key project objectives, facilitate existing client relations, develop individual project schedules, as well as department schedules, and provide communication between client, team members, management, and other stakeholders. As a member of the PMO team, the Project Manager leads efforts in tracking costs and progress against project milestones. The Project Manager will build and maintain strong, impactful processes to maintain relationships with Clients, internal team members and organizational leadership. The Project Manager must guide, influence, and collaborate using sound leadership skills. This position will report to the Research Services Program Manager
Manager of Program Management Office. Key Responsibilities
Guides team members in working together to identify and focus on essential project tasks and deliverables. Manages the Statement of Work (SOW) creation and approval process for less complex projects. Generates project plans including but not limited to milestones, hours, schedules, communications, risk analysis, etc. Works closely with management to ensure projects are appropriately resourced and championed. Prepares and leads kick-off and regular project team meetings with the clients for smaller work scopes. Works to balance competing constraints on the projects with available resources. Manages lower complex project elements, including but not limited to, scope, schedule, cost, resources, action items, and risks. Ensures the required manufacturing, quality, and regulatory documents, labels, and sampling plans are identified, resourced, created, and completed according to schedule. Ensures timely generation of client invoices, where applicable, and communication with the client and Finance. Manages identification, approval, and tracking of less complex Process Change Orders (PCO). 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. Supervises the daily operations and activities of the project such as scheduling and budget. Maintains and oversees the development process of the drug or product. Directs junior level reports. Work Location
Hybrid
this role is eligible for a hybrid schedule of 2 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! In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is delivering to patients. The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off
vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness. 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, engineering, or a directly related field from an accredited institution. Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year-for-year basis. 4 years of professional level experience in project management in a closely related regulatory industry. Preferred Qualifications: CAPM or PMP. Master's degree in a related field from an accredited college or university. Biomanufacturing, Pharmaceutical, Device manufacturing, or highly-regulated industry experience. Experience in negotiation. Experience working in an academic institution. Leadership training/certification. Eight (8) years of professional experience in project management or relevant technical experience. Experience providing mentorship and training. Competencies/Knowledge, Skills & Abilities: Leadership skills. Exceptional knowledge of project management process, skills, and tools. Strong critical thinking and problem-solving skills required. Ability to learn quickly and understand new technical concepts and processes. Exceptional multi-tasking and organizational skills, as well as the ability to make complex decisions in a fast-paced environment. Must possess a professional demeanor. Detail oriented, self-starter. Excellent interpersonal and customer service skills. Self-motivated and able to work in a team environment. Excellent knowledge of MS Office (especially Excel, PowerPoint, and Word). Knowledge of and the ability to work with the MRP System (Microsoft Dynamics/Great Plains). Knowledge of and the ability to work with web meeting tools (Zoom, Teams). Knowledge of and the ability to work with Smartsheets. Personable, friendly, and able to work well under pressure, especially when assisting customers. Excellent written and verbal communication skills as well as a keen ability to present data. Knowledge of GDP, GLP, GMP, CMC, and classified clean room practices/requirements. Basic knowledge of protein production and/or cell therapy processes. Strong financial acumen. 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. Strong negotiation skills and the ability to work effectively under pressure. How to Apply
For full consideration, please submit the following document(s): A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position Curriculum vitae / Resume Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address Questions should be directed to: Vanessa McWhirt, vanessa.mcwhirt@cuanschutz.edu Screening of Applications Begins
Immediately and continues until August 6,
University of Colorado Anschutz Medical Campus Department: Gates Institute Biomanufacturing Facility Job Title: Biomanufacturing Project Manager III Position #: 00837358
Requisition #:37355 Job Summary
This University Staff (non-classified) position will coordinate and schedule client projects, control document approval, and directly lead/coordinate project managers for technical project teams. This management position will oversee the achievement of overall and key project objectives, facilitate existing client relations, develop individual project schedules, as well as department schedules, and provide communication between client, team members, management, and other stakeholders. As a member of the PMO team, the Project Manager leads efforts in tracking costs and progress against project milestones. The Project Manager will build and maintain strong, impactful processes to maintain relationships with Clients, internal team members and organizational leadership. The Project Manager must guide, influence, and collaborate using sound leadership skills. This position will report to the Research Services Program Manager
Manager of Program Management Office. Key Responsibilities
Guides team members in working together to identify and focus on essential project tasks and deliverables. Manages the Statement of Work (SOW) creation and approval process for less complex projects. Generates project plans including but not limited to milestones, hours, schedules, communications, risk analysis, etc. Works closely with management to ensure projects are appropriately resourced and championed. Prepares and leads kick-off and regular project team meetings with the clients for smaller work scopes. Works to balance competing constraints on the projects with available resources. Manages lower complex project elements, including but not limited to, scope, schedule, cost, resources, action items, and risks. Ensures the required manufacturing, quality, and regulatory documents, labels, and sampling plans are identified, resourced, created, and completed according to schedule. Ensures timely generation of client invoices, where applicable, and communication with the client and Finance. Manages identification, approval, and tracking of less complex Process Change Orders (PCO). 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. Supervises the daily operations and activities of the project such as scheduling and budget. Maintains and oversees the development process of the drug or product. Directs junior level reports. Work Location
Hybrid
this role is eligible for a hybrid schedule of 2 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! In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is delivering to patients. The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off
vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness. 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, engineering, or a directly related field from an accredited institution. Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year-for-year basis. 4 years of professional level experience in project management in a closely related regulatory industry. Preferred Qualifications: CAPM or PMP. Master's degree in a related field from an accredited college or university. Biomanufacturing, Pharmaceutical, Device manufacturing, or highly-regulated industry experience. Experience in negotiation. Experience working in an academic institution. Leadership training/certification. Eight (8) years of professional experience in project management or relevant technical experience. Experience providing mentorship and training. Competencies/Knowledge, Skills & Abilities: Leadership skills. Exceptional knowledge of project management process, skills, and tools. Strong critical thinking and problem-solving skills required. Ability to learn quickly and understand new technical concepts and processes. Exceptional multi-tasking and organizational skills, as well as the ability to make complex decisions in a fast-paced environment. Must possess a professional demeanor. Detail oriented, self-starter. Excellent interpersonal and customer service skills. Self-motivated and able to work in a team environment. Excellent knowledge of MS Office (especially Excel, PowerPoint, and Word). Knowledge of and the ability to work with the MRP System (Microsoft Dynamics/Great Plains). Knowledge of and the ability to work with web meeting tools (Zoom, Teams). Knowledge of and the ability to work with Smartsheets. Personable, friendly, and able to work well under pressure, especially when assisting customers. Excellent written and verbal communication skills as well as a keen ability to present data. Knowledge of GDP, GLP, GMP, CMC, and classified clean room practices/requirements. Basic knowledge of protein production and/or cell therapy processes. Strong financial acumen. 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. Strong negotiation skills and the ability to work effectively under pressure. How to Apply
For full consideration, please submit the following document(s): A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position Curriculum vitae / Resume Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address Questions should be directed to: Vanessa McWhirt, vanessa.mcwhirt@cuanschutz.edu Screening of Applications Begins
Immediately and continues until August 6,