About the role

Aplyr's Quick Take

This role is for a Senior Process Chemist who will oversee early-phase drug manufacturing projects, ensuring compliance with regulatory standards while collaborating with external partners. It's an individual contributor position focused on managing the chemical development process and troubleshooting issues in GMP environments.

Good fit

Ideal candidates have a PhD or Master's in synthetic organic chemistry with 8-12 years of experience in pharmaceutical chemical development and GMP manufacturing. Strong collaboration skills and a hands-on approach are essential.

Worth noting

The position involves significant interaction with external partners and requires a deep understanding of GMP processes. The role is based in Hyderabad and may involve navigating complex regulatory environments.

Job Description Summary

We are looking for a highly motivated Process Chemist to manage early phase projects from GLP tox batches up to first-in-human API deliveries. In this role you will closely collaborate with CDMO’s in India but also work together with colleagues from other Novartis internal functions and sites.

You will be part of the chemical and analytical development team at our site in Genome Valley and report to the local team leader. As part of the Global Drug Development (GDD) team, this role is essential in ensuring the development of highest quality small molecule drug substances throughout the life cycle of each project, required to support clinical trials

Job Description

Key Responsibilities

Working as a Process Chemist in the External Partner Management (EPM) unit of Chemical and Analytical development (CHAD) group located in Hyderabad, India
Guiding external partners to plan, prepare, complete and document chemical manufacturing within CDMO facilities meeting regulatory and health authorities' expectations
Supervising GMP manufacturing activities such as master batch record handling, deviation handling and change control management
Support external manufacture to ensure timely delivery of drug substance and reviewing technical and GPM-relevant documents
Providing scientific guidance to external manufacturing teams, supporting daily business, troubleshooting etc.
Supporting CMC document writing and regulatory submissions
Actively managing interactions between internal and external partners to ensure a constructive and well-functioning collaboration
Participation in technical Drug Substance project team discussion (internal and external) and contribute to overall strategies and goals of chemical development projects
Supporting the set-up of data bases and document flow process within the EPM unit
Contribution to scientific exchange groups within Novartis and externally and evaluation, selection and onboarding process of new external partners

Minimum Requirements

PhD/ Masters (M.Sc.) in synthetic organic chemistry with 8-12 years of hands-on scale up experience in the pharmaceutical industry in chemical development and GMP manufacturing (development/commercial)
Proven hands-on experience in working in a GMP manufacturing environment and plants
Excellent knowledge of manufacturing plants & facilities and related documentations (like tech transfer documents, BMR, deviation management, CAPA, etc)
Successfully demonstrated expertise in scale up of drug substance from lab to plant
Proficient English (oral and written).
Strong coordination and communication skills, collaborative spirit, self-driven attitude, high level of learning agility are key attitudes

Skills Desired

Clinical Data Management, Data Architecture, Data Governance, Data Integration, Data Management, Data Profiling, Data Quality, Data Science, Data Strategy, Master Data, Waterfall Model

Aplyr's read

Novartis is a Swiss-based global healthcare leader, known for its focus on innovative medicines and commitment to addressing patient needs through diverse roles.
Synthesized from recent postings & public sources

What's promising

•Novartis invests heavily in research and development, driving innovation in pharmaceuticals.
•The company offers a wide range of global career opportunities across various fields.
•Strong focus on cutting-edge therapies, including gene therapy and AI-driven solutions.

What to watch

•Regulatory challenges can impact the speed of drug approval and market entry.
•High competition in the pharmaceutical industry requires constant innovation to maintain market position.
•Complex organizational structure may slow decision-making processes.

Why Novartis

•Novartis has a robust pipeline of innovative medicines, setting it apart in the healthcare sector.
•The company emphasizes a diverse and inclusive workplace culture across its global operations.
•Novartis is a leader in digital transformation within pharmaceuticals, integrating AI and data science.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Novartis

Novartis

novartis.com

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Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. It focuses on innovative medicines, generics, and eye care.