AI Technologies LLC.
IT Technical Program Manager (Java/Pharma Domain)
AI Technologies LLC., Trenton, New Jersey, United States
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 are 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: AI TECHNOLOGIES LLC 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. AI TECHNOLOGIES LLC 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 AI TECHNOLOGIES LLC 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
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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 are 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: AI TECHNOLOGIES LLC 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. AI TECHNOLOGIES LLC 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 AI TECHNOLOGIES LLC 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
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