Senior Expert (Analytical R&D) - Gc.

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 (Analytical R&D) - GC
Job ID: REQ-10030397
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

As a Senior Expert (Analytical R&D) specializing in Gas Chromatography (GC), your role is to plan and perform scientific experiments and processes that contribute to the preparation and timely delivery of drug substances (DS) and drug products (DP). You will be working within a multifunctional project team, ensuring that experiments meet quality, quantity, and timelines while collaborating closely with other team members.

Key Responsibilities

Scientific Experimentation & Documentation:
- Plan and execute scientific experiments under minimal guidance from experienced team members.
- Document raw data and evaluate the results. Propose designs for future experiments and contribute to method optimization and development.
- Generate lab procedures, reports, and SOPs (Standard Operating Procedures).
Collaboration & Mentorship:
- Collaborate with team members to facilitate the delivery of drug substances and drug products.
- Act as a mentor for new team members.
- Actively participate in project teams, meetings, and networks, contributing to team goals.
Technical Expertise & Lab Equipment:
- Use specialized equipment and facilities for experiments (e.g., containment or sterile labs).
- Evaluate and maintain lab equipment, perform routine maintenance and calibration, and contribute to maintaining lab infrastructure.
Process Improvement & Safety:
- Ensure all activities comply with safety protocols, including safe handling of chemicals and equipment.
- Actively participate in process improvement activities and ensure compliance with cGMP, GLP, and other relevant guidelines.
Regulatory & Scientific Compliance:
- Ensure activities align with overall drug development processes and adhere to Novartis' policies, SOPs, GMP, GLP, and other relevant regulations.
- Provide strategic and scientific contributions to projects, meeting annual objectives.

What You’ll Bring to the Role

Educational Requirements:

PhD in a relevant technical subject with 4 years of relevant experience, or Master of Science (MSc) with 8+ years of relevant experience.

Skills & Experience:

Expertise in gas chromatography-based quantification methods using various detectors, including GC-FID.
Proficient in handling OOS/OOE (Out of Specification/Out of Expectation) and deviations involving analytical techniques.
Strong experience in de-formulation studies of drug products, including microscopic evaluation of drug components.
Familiarity with Good Manufacturing Practices (cGMP) and advanced scientific/technical writing skills.
Proficiency with laboratory tools and software, and good documentation skills.

Additional Attributes:

Fluent in English (oral and written).
Strong awareness of chemical safety and handling potentially hazardous materials.
Broad theoretical and scientific knowledge in relevant areas (e.g., manufacturing, analytical, pharmaceutical).

Why Novartis?

Novartis is committed to improving lives through innovative science. By joining their team, you'll be part of a community that values collaboration, support, and inspiration. Working at Novartis provides an opportunity to be part of breakthroughs that change the lives of patients globally.

For more information about Novartis' mission and values, visit their People & Culture Strategy and Benefits & Rewards pages.

Join the Novartis Network:
If this role doesn't align with your experience or career goals, but you want to stay connected with Novartis for future opportunities, sign up for their talent community here.

This Senior Expert role will allow you to leverage your expertise in analytical techniques to contribute to the development of drug substances and products, while working in a collaborative and cutting-edge research environment.

ity here.

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Senior Expert (Analytical R&D) - Gc.

Job Description

Role Overview

Key Responsibilities

What You’ll Bring to the Role

Educational Requirements:

Skills & Experience:

Additional Attributes:

Why Novartis?

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