Senior Process Expert

Novartis

3+ years

Not Disclosed

United States

10 April 18, 2025

Job Description

Job Type: Full Time Education: B.Sc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Process Expert – Morris Plains, NJ
Job ID: REQ-10046809
Apr 09, 2025
USA

Summary
The Senior Process Expert will provide team coordination and support on process issues and investigations. This role aims to drive process excellence initiatives, improving site quality and efficiency in compliance with cGMPs, SOPs, and applicable regulations. This position is located on-site in Morris Plains, NJ. Relocation support is not available.

About the Role
Major Accountabilities:

Business Process & Improvements:
- Lead and coordinate multi-disciplinary teams (Manufacturing, MS&T, Development, etc.) for process and material/equipment improvements.
- Identify opportunities for operational, process, and quality improvements in conjunction with the Manufacturing Team and Operational Excellence Program.
- Provide oversight and support for Corrective/Preventative Actions, Quality Events, and continuous improvement projects.
- Collaborate with the regulatory department to ensure process improvements align with regulatory frameworks.
- Develop team standardization initiatives and provide job-aid materials.
- Oversee change control for process and product-related changes.
Technical Improvement Execution:
- Own and drive change controls related to process improvements that support manufacturing initiatives.
- Support execution of improvement projects by liaising with relevant parties on the shop floor to ensure accuracy.
- Manage multiple investigational topics for technical oversight and audit readiness.
- Review and ensure technical correctness of protocols and reports.
- Execute process improvements and scale-ups, ensuring technical batches generate sufficient process knowledge.
Deviations, Investigations, and CAPAs:
- Author high-criticality investigations, CAPAs, and effectiveness checks within required timelines.
- Communicate and coordinate with departments such as Technical Research & Development, Manufacturing Science & Technology, and others.
- Ensure all CAPAs are implemented through GMP systems.
- Analyze data to identify root causes of process and product failures.
Shop Floor Support:
- Provide technical and procedural support to manufacturing teams, ensuring batches are produced safely and on time in compliance with batch instructions.
- Lead decision-making for process interventions as needed and share best practices from investigations and CAPAs.
Training:
- Develop and deliver training to the Cell Processing team in response to unexpected events and technical document execution.
- Coach new investigators as part of the Investigator Certification Program and maintain compliance with training requirements.
Audit Support:
- Maintain process knowledge at inspection readiness level and provide necessary support in internal or external audits.
- Maintain understanding of investigational topics to support audits.

Pay Range
The pay range for this position is expected to be between $81,200 to $150,800/year. Final pay determinations will depend on geographical location, experience, skills, and abilities. Total compensation may also include additional elements such as sign-on bonuses, restricted stock units, and discretionary awards.

Minimum Requirements

BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy, or an equivalent scientific degree; MSc. preferred.
3 years’ experience in a GMP manufacturing role on the shop floor.
2+ years’ experience in investigation writing and root cause analysis.
Proven understanding of pharma, GMP, and regulatory aspects.
2+ years’ experience with deviation/root cause analysis and extended knowledge of CAR-T products.

Why Novartis?
At Novartis, we aim to make a difference in the lives of patients through innovative science and a collaborative team environment. Join us in helping people live longer, healthier lives by creating a brighter future together.

EEO Statement
Novartis is an Equal Opportunity Employer, committed to diversity and inclusion.

For more information on benefits and rewards, please visit: Novartis Benefits.

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Senior Process Expert

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