Project Manager

System One Clinical & Science; Indianapolis (IN); On-site; USD 96,000 - 105,000; Full time

Job summary

System One Clinical & Science is seeking a Project Manager in Indianapolis, IN for an 18-month onsite contract. You will lead strategic and operational project efforts across API external manufacturing, coordinating quality, supply chain, engineering, regulatory, and finance with a focus on reliable commercial supply.

The role requires a bachelor’s in a technical field and at least 5 years in pharmaceutical/biopharmaceutical operations, with PMP or MS/MBA preferred.

Qualifications

• Bachelor's degree in engineering, a scientific field, or a related technical discipline and minimum of 5 years in pharmaceutical/biopharmaceutical operations.
• Advanced degree or professional certification (MS, MBA, Master’s in Project Management, PMP, or a commissioning/qualification/validation credential) preferred.

Responsibilities

• Facilitate and support CMO oversight and project delivery.
• Create and manage an integrated project plan articulating strategy for the CMO relationship and milestones.
• Coordinate cross-functional obligations between company and the CMO (quality oversight, supply coordination, deviation/CAPA, change-control, contracts, governance).
• Create and execute project plans; drive milestone delivery across the lifecycle.
• Develop team communication plans; inform stakeholders and leadership of decisions, risks and results.
• Monitor and prioritize project and supply risks; propose mitigations and contingencies.

Education

Bachelor's degree in engineering, a scientific field, or a related technical discipline

Advanced degree or professional certification (MS, MBA, Master’s in Project Management, PMP)

Tools

MS Project

Primavera P6

Smartsheet

Job description

Job Title: Project Manager
Location: Indianapolis, IN
Work Model: Onsite
Hours: M-F 8am-5pm
Compensation: $70.00 - $75.90/hr
Type: 18-month contract

OverviewClient is seeking a Project Manager to provide strategic and operational project leadership across API external manufacturing, supporting the management of commercial supply and related initiatives at a contract manufacturing organization (CMO). This role integrates activities across quality, supply chain, engineering, regulatory, and finance, translating program strategy into disciplined execution to ensure reliable commercial supply of key therapeutics.

• Responsible for facilitating and supporting CMO oversight and project delivery, including the following:
• Manage scope and support creation of an integrated project plan that articulates the strategy for the CMO relationship and its key initiatives, and provides the foundation for operational objectives and milestones.
• Coordinate cross-functional obligations between company and the CMO, including quality oversight, supply coordination, deviation/CAPA and change-control interfaces, and contract and governance commitments.
• Create and execute project plans and drive delivery of project milestones across the initiative lifecycle.
• Develop and implement team communication plans and drive communication of key decisions, risks, and results to stakeholders and leadership.
• Monitor and prioritize project and supply risks, suggest ways to avoid or mitigate risks, and initiate contingency plans as needed.
• Bring forward areas for continual process improvement to strengthen schedule discipline, reduce cost, and improve reliability of commercial supply and project delivery.
• Drive development of an integrated project budget and support financial governance, ensuring alignment with functional representatives, finance, and leadership.
• Proficient in self-management and organizational skills; able to manage workload, set personal and team priorities, and adjust as needed in a dynamic, multi-workstream environment.
• Strong interpersonal and team-building skills; able to develop effective teamwork between company and CMO team members with diverse styles and across organizational boundaries.
  

Job Title: Project Manager
Location: Indianapolis, IN
Work Model: Onsite
Hours: M-F 8am-5pm
Compensation: $70.00 - $75.90/hr
Type: 18-month contract

OverviewClient is seeking a Project Manager to provide strategic and operational project leadership across API external manufacturing, supporting the management of commercial supply and related initiatives at a contract manufacturing organization (CMO). This role integrates activities across quality, supply chain, engineering, regulatory, and finance, translating program strategy into disciplined execution to ensure reliable commercial supply of key therapeutics.

• Responsible for facilitating and supporting CMO oversight and project delivery, including the following:
• Manage scope and support creation of an integrated project plan that articulates the strategy for the CMO relationship and its key initiatives, and provides the foundation for operational objectives and milestones.
• Coordinate cross-functional obligations between company and the CMO, including quality oversight, supply coordination, deviation/CAPA and change-control interfaces, and contract and governance commitments.
• Create and execute project plans and drive delivery of project milestones across the initiative lifecycle.
• Develop and implement team communication plans and drive communication of key decisions, risks, and results to stakeholders and leadership.
• Monitor and prioritize project and supply risks, suggest ways to avoid or mitigate risks, and initiate contingency plans as needed.
• Bring forward areas for continual process improvement to strengthen schedule discipline, reduce cost, and improve reliability of commercial supply and project delivery.
• Drive development of an integrated project budget and support financial governance, ensuring alignment with functional representatives, finance, and leadership.
• Proficient in self-management and organizational skills; able to manage workload, set personal and team priorities, and adjust as needed in a dynamic, multi-workstream environment.
• Strong interpersonal and team-building skills; able to develop effective teamwork between company and CMO team members with diverse styles and across organizational boundaries.
  

Requirements

• Bachelor's degree in engineering, a scientific field, or a related technical discipline, and a minimum of 5 years of relevant experience in pharmaceutical/biopharmaceutical operations.
• Advanced degree or professional certification (e.g., MS, MBA, Master's in Project Management, PMP, or a commissioning/qualification/validation credential) preferred.
• Experience overseeing project lifecycle of commercial or external manufacturing at a contract manufacturer (CMO/CDMO), including quality oversight, supply coordination, deviation/CAPA and change-control interfaces, and contract governance.
• Demonstrated experience applying project management tools and processes - scheduling, risk management, phase-gate/stage-gate governance - across cross-functional teams spanning quality, supply chain, engineering, regulatory, and finance in a GMP environment.
• Proficiency with Microsoft Word, Excel, PowerPoint, and project scheduling tools (e.g., MS Project, Primavera P6, Smartsheet), and capable of maintaining appropriate project documentation.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.