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Senior Expert (Analytical R&D) - Gc

0-2 years
Not Disclosed
10 Feb. 19, 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
Company: Novartis Healthcare Private Limited


About the Role:

The Senior Expert (Analytical R&D) - GC is an essential position within the Research & Development team at Novartis. This role focuses on performing scientific experiments and pilot plant processes to prepare and deliver drug substances and drug products in collaboration with a multifunctional project team. You will contribute to the maintenance and optimization of lab instruments and infrastructure while applying expertise in gas chromatography-based quantification methods.


Key Responsibilities:

  • Scientific Experiments: Plan and conduct scientific experiments for drug substance (DS) and drug product (DP) preparation, ensuring quality, quantity, and timely delivery.

  • Data Documentation: Document raw data, interpret and report results, and propose experimental designs for future experiments.

  • Process Improvement: Optimize existing methods or contribute to the development of new ones, including reproducing published methods and improving efficiency.

  • Lab Procedures: Develop and transfer lab procedures, reports, SOPs, and instructions to the pilot plant or production, including troubleshooting and process steering controls.

  • Chemicals Management: Manage chemicals, intermediates, excipients, and solvents within your area of responsibility.

  • Team Collaboration: Work with internal teams to facilitate the timely delivery of DS and/or DP. Mentor new joiners.

  • Equipment Maintenance: Use specialized tools and equipment, perform routine maintenance, and contribute to the upkeep of infrastructure.

  • Project Participation: Actively engage in project teams, meetings, and networks, contributing to team goals and overall drug development processes.

  • Compliance: Ensure activities align with SOPs, GMP, GLP, and other relevant guidelines, and contribute strategically to networks and team objectives.


Qualifications:

  • Education: PhD in a technical subject (with 4 years of relevant experience) or MSc with 8+ years of relevant experience.

  • Experience: Proficiency in gas chromatography-based quantification methods (including GC-FID) and experience handling OOS/OOE and deviations.

  • Technical Skills: Skilled in using laboratory tools and equipment, with good knowledge of computer software (e.g., Office Suite, SAP).

  • GMP Knowledge: In-depth understanding of current Good Manufacturing Practices (cGMP) and scientific/technical writing skills.

  • Safety Awareness: Knowledge of safe handling of chemicals and potentially hazardous materials.

  • Additional Skills: Experience in de-formulation studies and microscopic evaluation of drug components is a plus.


Why Novartis?

At Novartis, our mission is to reimagine medicine and improve and extend people’s lives. We are committed to fostering a collaborative, inclusive, and innovative work environment. Join us and be part of a team that’s driving breakthroughs in medicine.

  • Diversity & Inclusion: Novartis is dedicated to building a diverse team that reflects the patients and communities we serve.

  • Benefits & Rewards: Learn more about the benefits of working at Novartis by exploring our Benefits Handbook.


How to Apply:

If you are interested in this role, apply through the Novartis Career Portal.


Additional Information

  • Accessibility: Novartis is committed to providing reasonable accommodations for individuals with disabilities during the recruitment process. For assistance, please contact diversityandincl.india@novartis.com.


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