MES Program/Portfolio Manager
Lexington, Middlesex County, Massachusetts, 02173, USA
Listed on 2026-11-07
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IT/Tech
IT Project Manager, IT Consultant, Business Systems & Technology Analysis, Systems Engineer
USDM Life Sciences is an AI solutions and process automation company built for life sciences — helping pharmaceutical, biotech, and medical device organizations put AI to work across real workflows and scale it safely. With 25 years of deep domain expertise and 900+ global clients, we have the capability to build and deploy AI into regulated environments backed by the governance practice that makes every deployment defensible under FDA, GAMP 5, and emerging AI regulations.
Our proprietary TRUST-AI Framework guides clients from AI readiness through governed deployment to enterprise scale.
From strategy through implementation and adoption, we have delivered thousands of GxP projects globally — and we are leading the industry's next evolution. Through partnerships with Microsoft, Google, Oracle, Box, Docu Sign, and more, our team helps connect technology, people, and data in ways that generate real outcomes for the organizations that make, regulate, and bring life-saving products to market.
Founded in Santa Barbara in 1999, USDM has grown to a global company with offices throughout the US, Canada, and Germany.
Nature and Scope of JobPortfolio/Program manager for multiple concurrent Manufacturing Execution System (MES) projects at MA Bio Ops, tracking all relevant milestones and related Change Controls and CAPAs.
Primary Responsibilities- 3+ years’ experience with MES systems (PAS‑X preferred) as well as relevant interfaces (ERP, Automation, Lab Systems).
- Direct experience with Biologics manufacturing processes and equipment.
- Understand the ISA‑95 and ISA‑88 models.
- 5+ years’ experience in digital project and program management in a GMP environment.
- Experienced with common project management methodologies including Agile and Waterfall.
- Expected to be able to work independently, take initiative, and navigate complex matrixed environment to influence individuals and teams across the organization.
- Comfortable working with external vendors, where applicable.
- Able to lead meetings, identify projects risks, and understand cross project dependencies.
- Performs other related duties and assignments as required
- Experience with PAS‑X MES system.
- Experience with Track Wise, Veeva systems (or similar)
- Experience with Atlassian’s Confluence and JIRA software.
- Knowledge of Automation Systems in GMP manufacturing operations.
- Bachelor’s degree in Computer Science or Information Systems or related field.
- Master’s Degree preferred
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
- Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
- Operate other office productivity machinery, such as a calculator, scanner, or printer.
- Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
DisclaimerThis job description is intended to describe the general nature and the level of the work being performed…
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