Project Manager

Process Alliance; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Process Alliance in Indianapolis, IN is seeking a Project Manager to lead pharmaceutical manufacturing scale-up and production of API for a specific molecule, partnering with cross-functional teams across operations, engineering, and quality.

You will manage end-to-end project execution, timelines, risks, and dependencies, ensuring GMP and regulatory alignment and a successful transition into manufacturing.

Qualifications

• 3+ years of project management experience in a pharmaceutical, biotech, or regulated manufacturing environment.
• Pharmaceutical project experience required.
• Working knowledge of GMP regulations and operating in a regulated environment.
• Strong understanding of project management principles, tools, and methodologies.

Responsibilities

• Lead end-to-end project management activities including planning, scheduling, execution, and delivery.
• Drive cross-functional coordination across operations, engineering, quality, and supply chain teams.
• Develop and manage project timelines, milestones, and deliverables to ensure on-time execution.
• Track risks, issues, and dependencies, and drive mitigation strategies.
• Facilitate project meetings, provide status updates, and ensure alignment across stakeholders.
• Support operational readiness efforts to ensure successful transition into manufacturing.

Skills

Project management

Communication

Stakeholder management

Regulatory understanding

Education

Bachelor's degree in Engineering, Life Sciences, Business, or related field

Job description

Process Alliance is a leading engineering consultancy firm dedicated to delivering innovative solutions in engineering, automation, manufacturing services, and medical devices. With a commitment to being a better model of problem solving, we have been at the forefront of providing cutting-edge engineering services to clients across the life science industry. Our team of experts thrives on solving complex challenges and driving technological advancements to meet the evolving needs of our clients.

Overview:

We are seeking a Project Manager to support key initiatives within a pharmaceutical manufacturing environment. This role will focus on driving project execution for the scale-up and production of active pharmaceutical ingredients (API) for a specific molecule, partnering closely with cross-functional teams across operations, engineering, and quality.

Key Responsibilities:

• Lead end-to-end project management activities including planning, scheduling, execution, and delivery
• Drive cross-functional coordination across operations, engineering, quality, and supply chain teams
• Develop and manage project timelines, milestones, and deliverables to ensure on-time execution
• Track risks, issues, and dependencies, and drive mitigation strategies
• Facilitate project meetings, provide status updates, and ensure alignment across stakeholders
• Support operational readiness efforts to ensure successful transition into manufacturing
• Ensure project activities align with GMP and regulatory expectations
• Support documentation, change management, and project reporting as needed

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Business, or a related field
• 3+ years of project management experience in a pharmaceutical, biotech, or regulated manufacturing environment
• Pharmaceutical project experience required
• Working knowledge of GMP regulations and experience operating in a regulated environment
• Strong understanding of project management principles, tools, and methodologies
• Excellent communication and stakeholder management skills
• Ability to manage multiple projects in a fast-paced setting

Preferred:

• Experience supporting operational readiness, tech transfer, or manufacturing start-up activities

Qualified applicants must be authorized to work in the United States on a full-time basis. Process Alliance will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

About Our Culture:

At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.

Location:

Much of our work is focused on the Indianapolis, Indiana area, however we have employees and projects from coast to coast and internationally. Candidates from all U.S. locations are welcome to apply.

Learn more about us:

Visit our website at www.processalliance.com to explore our projects, expertise, and the impact we make in the engineering and consultancy space.

Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.