Senior Specialist Master Batch Record (Mbr) Design

3+ years

Not Disclosed

Italy

10 Jan. 30, 2025

Job Description

Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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

Job Title: Senior Specialist Master Batch Record (MBR) Design

Location: Ivrea, Italy

Time Type: Full-time
Job Requisition ID: REQ-10038386

Role Overview:

The Senior Specialist Master Batch Record (MBR) Design plays a pivotal role in supporting Manufacturing Execution Systems (MES) at Novartis Radioligand Therapy (RLT) sites. This role is focused on the design, delivery, and update of Master Batch Record (MBR) design elements, ensuring alignment with global core processes. The individual will also be responsible for providing MES training and best practice sharing across Novartis RLT sites, with an emphasis on process standardization, harmonization, and managing future MES business requirements.

Key Responsibilities:

1. MBR Design & Process Alignment

Design and update Master Batch Records (MBRs) to ensure alignment with global core processes.
Provide business support during Site MES Deployment Projects.
Conduct site process analysis and fit-gap analysis to prepare for projects in collaboration with Global Process Business Owners.
Ensure that MBRs are designed and updated according to the latest requirements and best practices.

2. MES Governance & Best Practices

Manage and update guidelines in accordance with global MES governance rules.
Review and consolidate MES software errors, collaborating with the MES IT team to prioritize and resolve them.
Attend Change Advisory Board meetings, prioritize MES Business Change requests.

3. Training & Collaboration

Conduct regular training sessions on MES for employees and teams across all business units and manufacturing facilities.
Facilitate effective collaboration across business units and manufacturing facilities, ensuring standardization and process harmonization.

4. Relationship Management & Reporting

Build and maintain effective relationships with internal teams and senior management.
Leverage digital technology and big data to support MES optimization and decision-making processes.

Required Qualifications & Experience:

Experience:

Proven experience in MBR design, ideally within the pharmaceutical industry.
Track record of collaborating across boundaries and influencing without authority.
Experience in relationship management and multinational/global exposure.
Familiarity with Manufacturing Execution Systems (MES) is a significant advantage.

Skills:

Analytical Thinking: Ability to analyze processes and identify areas for improvement.
Communication Skills: Strong verbal and written communication skills, including the ability to influence and collaborate effectively across teams.
Requirements Analysis: Ability to gather and assess business and system requirements to ensure efficient MES implementation.

Languages:

Fluency in Italian and English (both written and spoken) is required.

Why Join Novartis?

Be a part of a global, innovative team that is dedicated to improving processes and driving success across Novartis Radioligand Therapy (RLT) sites.
Develop and grow within a company committed to efficiency, compliance, and continuous improvement.
Contribute to the advancement of Manufacturing Execution Systems at a global scale.

Diversity & Inclusion Commitment:

Novartis is committed to fostering an inclusive and diverse work environment, representative of the patients and communities we serve.

🔗 Apply now to be part of a dynamic and impactful team!

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