IT Technical Program Manager (Java/Pharma Domain)

Cloud Hybrid Technologies LLC; New Jersey; On-site; USD 96,000 - 165,000; Full time

Job summary

Cloud Hybrid Technologies LLC is seeking an IT Technical Program Manager (Java/Pharma Domain) in New Jersey to lead and oversee IT initiatives supporting cell therapy digital platforms within regulated pharmaceutical environments. You will engage with MES, LIMS, SAP, and scheduling systems to drive manufacturing and compliance.

The role requires extensive IT leadership experience (15-17+ years) with 7+ years in TPM in the US pharma sector, deep knowledge of GxP, and ability to manage vendor

Qualifications

• 15-17+ years of IT experience
• 7+ years in technical program management in US pharma
• Strong knowledge of GxP and regulatory requirements (21 CFR Part 11)
• Experience with digital manufacturing systems and validation lifecycle

Responsibilities

• Lead and oversee IT initiatives supporting cell therapy digital platforms in regulated pharma environments.
• Coordinate cross-functional teams including Digital, Engineering, QA, Regulatory, and Manufacturing.
• Develop validation strategy and oversee CSV planning across complex digital systems.

Skills

IT leadership

Program management

Pharma domain knowledge

GxP awareness

Tools

MES

LIMS

SAP

Scheduler

Control systems

System integration

Job description

IT Technical Program Manager (Java/Pharma Domain)

Location:

New Jersey,NJ

Duration:

12Months + Extension

Hourly Rate:

Depending on Experience (DOE)

Work Authorization:

Role Overview:Lead and oversee IT initiatives supporting cell therapy digital platforms that drive manufacturing, orchestration, integration, and compliance within regulated pharmaceutical environments—spanning vendor systems such as MES, LIMS, SAP, and scheduling systems.

Key Responsibilities:

• Overall 15-17+ years of IT experience and 7+year of experience in technical program management with deep experience in US pharma, Drug Manufacturing, Cell Therapy and US pharma regulations.
• Cross‑Functional Program Leadership
• Coordinate with Digital, Engineering, Quality, Regulatory, QA, and Manufacturing teams.
• Strong knowledge of GxP regulations, validation lifecycle, and digital manufacturing system landscapes.
• Experience with MES, LIMS, SAP, Scheduler, Control systems, integration architectures.
• Experience in personalized or cell therapy manufacturing environments.
• Familiarity with digital validation frameworks in CAR-T and related cell therapy platforms.
• Computer System Validation (CSV)
• Develop validation strategy and execute CSV planning across complex digital systems.
• Embed GxP (21 CFR Part 11, Annex 11) requirements early during design.
• Regulatory Readiness & Inspection Support
• Ensure platforms is inspection-ready for BLA submissions and manufacturing transitions.
• Represent Digital in regulatory audits and inspections.
• Technical and Architectural Oversight
• Engage in technical design/architecture discussions to de-risk validation.
• Ensure integration readiness across systems (e.g., mINT Engine, Scheduler, Control Tower).
• Business Engagement & Leadership
• Able to drive cross-functional alignment and clear communication across scientific, operational, IT, and QA/regulatory teams.
• Capable of managing vendors, delivering on complex project scopes, milestones, timelines.

Required Technical Expertise:

Cloud Hybrid is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. Cloud Hybrid will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will Cloud Hybrid require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract