Project Manager, Operations Management, Regulatory Compliance Specialist
Listed on 2026-10-05
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Business
Operations Management, Regulatory Compliance Specialist, Change Management
Location: Olde West Chester
A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to‑end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit
Brief Job Description
The Project Manager I (PM I) is responsible for supporting and managing client-facing projects within a drug contract manufacturing organization (CDMO). This role serves as a key point of coordination between clients and internal cross‑functional teams to ensure project milestones, deliverables, and timelines are achieved. The Project Manager I (PM I) manages projects of moderate complexity and supports technical transfer, development, manufacturing, and supply chain activities throughout the project lifecycle.
Working under general direction, the PM I develops project plans, tracks schedules, facilitates communication, and proactively identifies project risks. The Project Manager I (PM I) contributes to customer satisfaction by building productive client relationships and ensuring effective collaboration among technical, quality, manufacturing, and commercial teams.
- Manage assigned client projects from initiation through completion.
- Develop and maintain project timelines, action item logs, and status reports.
- Coordinate project activities across Manufacturing, Quality, Supply Chain, MS&T, Regulatory Affairs, and Product Development teams.
- Ensure project deliverables are completed according to agreed timelines and scope.
- Support technical transfer and manufacturing readiness activities.
- Serve as the day‑to‑day client contact for assigned programs.
- Facilitate routine project meetings and provide project status updates.
- Maintain regular communication with clients regarding project progress, risks, and key milestones.
- Support preparation of client presentations and project review meetings.
- Coordinate activities across multiple functional groups to ensure alignment and execution of project objectives.
- Drive accountability for assigned action items and project commitments.
- Escalate issues, resource constraints, and timeline risks as appropriate.
- Maintain project schedules and monitor milestone performance.
- Support budget tracking, purchase requests, and project forecasting activities.
- Assist with change order documentation and monitoring project scope changes.
- Identify project risks and issues and support development of mitigation plans.
- Track project changes and ensure appropriate communication to stakeholders.
- Escalate significant risks and delays in a timely manner.
- Ensure adherence to GMP, quality systems, SOPs, and regulatory requirements.
- Maintain project documentation consistent with company procedures.
Minimum Requirements
- Previous experience in project coordination, project management, manufacturing, development, or operations experience within biotechnology, pharmaceutical, CDMO, or related industries.
- Understanding of pharmaceutical manufacturing processes and GMP requirements.
- Strong organizational, communication, and stakeholder management skills.
- Experience using project management tools such as Microsoft Project, Smartsheet, or equivalent.
- Ability to manage multiple priorities in a fast‑paced environment.
Preferred Background
- 2–4 years of project coordination, project management, manufacturing, development, or operations experience within biotechnology, pharmaceutical, CDMO,…
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