Senior Expert, Science & Technology (Epm Specialist)

0-2 years

Not Disclosed

Hyderabad India

10 Feb. 13, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Expert, Science & Technology (EPM Specialist)
Job ID: REQ-10037171
Location: Hyderabad, India
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Employment Type: Full-time, Regular
Company / Legal Entity: Novartis Healthcare Private Limited

Role Overview

The EPM Specialist within the Global Drug Development (GDD) team plays a critical role in ensuring the highest quality development of small molecule drug substances throughout their lifecycle to support clinical trials. This role involves managing externalized processes related to R&D, ensuring regulatory compliance, and optimizing collaboration with external partners.

Key Responsibilities

Process Improvement & Externalized Activities:
- Lead and own process improvement activities related to externalized R&D processes.
- Oversee and document workflows related to externalized business, including both GMP and non-GMP processes.
- Manage and evaluate data from external activities, including compiling relevant KPIs for regular evaluations with external partners.
Regulatory & Documentation Support:
- Support the creation and submission of CMC documents and regulatory submissions.
- Participate in the evaluation, selection, and onboarding of new external partners.
Collaboration & Partner Management:
- Actively manage interactions between internal and external partners to foster constructive and well-functioning collaboration.
- Participate in scientific and technical exchanges with both internal stakeholders and external partners.
GMP Activities & External Manufacturing Support:
- Supervise GMP activities, including handling master batch records, executed batch records, deviation handling, and change control management.
- Support the external manufacturing process to ensure the timely delivery of drug substances.
Continuous Improvement & Data Management:
- Identify and support continuous improvement initiatives related to external partners and internal processes.
- Assist in setting up databases and document flow processes within the EPM unit.
- Own, develop, and maintain the team SharePoint for knowledge management and collaboration.

What You’ll Bring to the Role

Education & Experience:

Desirable: PhD or MSc in Chemistry, Chemical Engineering, or a related field.
A minimum of 3 years of experience in the pharmaceutical industry, specifically in chemical development and/or commercial activities.
Proven experience working in a GMP environment, including activities such as manufacturing, deviation handling, change control, and documentation.
Expertise in a specific scientific or technical area is highly valued.

Skills & Competencies:

Communication & Coordination: Strong coordination and communication skills with a collaborative spirit and self-driven attitude.
Data Management & IT Tools: Excellent proficiency in data management and tools like Microsoft Office (Excel, SharePoint, MSTeams), SAP, and planning tools.
Operational Excellence: Knowledge of operational excellence principles, with Six Sigma certification being a plus.
Procurement Experience: Experience in procuring APIs, intermediates, raw materials, and services, including managing RFPs and RFIs is a plus.
Fluency in English: Proficiency in both oral and written English is required.

Desirable Attributes:

High learning agility, personal inclination for IT solutions, and a proactive attitude toward problem-solving.

Why Novartis?

Novartis is driven by the mission to help people with disease and improve their lives through innovative science. It offers a collaborative environment where diverse perspectives are celebrated, fostering personal and professional growth. The company is committed to providing a strong network of support, resources, and a range of career development opportunities.

For more details about Novartis' culture and employee benefits, visit their People & Culture Strategy and Benefits & Rewards pages.

Join the Novartis Network:
If you're interested in staying connected and exploring other opportunities at Novartis, you can sign up for their talent community here.

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Senior Expert, Science & Technology (Epm Specialist)

Job Description

Role Overview

Key Responsibilities

What You’ll Bring to the Role

Education & Experience:

Skills & Competencies:

Desirable Attributes:

Why Novartis?

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