Job Description Summary
To lead and manage all assigned project/network activities within PHAD and apply scientific/technical expertise to address complex R&D issues for the preparation and timely delivery of drug products (DP), processes and procedures.
Job Description
Millions! Novartis made a decision to pursue early discovery research internally to allow us to quickly translate the most impactful discoveries into therapeutics for millions of patients.
The job purpose is to lead and manage all assigned project/network activities and apply scientific/technical expertise to address complex R&D issues for the preparation and timely delivery of drug products (DP), processes and procedures; participate in teams and contribute to overall Technical Research and Development strategies and goals.
To develop our growing pipeline of products we are looking for experienced professionals in the area of pharmaceutical development. In this challenging position, you will play a key role in the development of parenteral dosage form.
The position is based in the Genome Valley, Hyderabad, within the Technical Research and Development Organization (TRD) of Global Drug Development (GDD).
YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:
• Plan and support development of early and late phase NCE development for parenteral dosage forms (including poorly soluble compounds).
• Plan and support entire drug product development process starting with first pre-formulation studies up to the manufacturing process transfer to production and the provision of the required documentation to allow worldwide registration.
• Support development of robust formulations and processes through optimization, scale-up and validation work applying QbD principles incl. risk assessments and DoEs.
• Strong scientific background w.r.t biopharmaceutics and its application in DP development.
• Provide documentation of raw data, evaluation and contribute to interpretation of results. Provide input for the selection of next experiments.
• Communicate and address problems, perform safety and literature searches under guidance from more experienced team members.
• Meet quality, quantity and timelines in all assigned projects.
• Perform and document scientific experiments.
• Representation of Pharmaceutical Development as formulation project leader in global CMC teams, functional representative in cross-functional teams.
• Evaluation and implementation of new methods and technologies, scientific contributions, supervision of research projects and initiation of new research activities.
WHAT YOU’LL BRING TO THE ROLE:
- M. Pharm with 7 to 10 years of experience or PhD in Science with focus on pharmaceutical sciences and technology (e.g. Pharmacy, Chemistry) with 5+ years of experience.
- Experience in the development, scale-up and technology transfer of Parenteral Drug Product manufacturing processes is required.
- Background in aseptic process development of parenteral product is required
- Thorough understanding of aseptic fill-finish unit operations (i.e. filling, filtration, mixing, lyophilization etc.) and equipment for scale-down model development and process characterization is required.
- Experience with regulatory filings (IND/IMPD etc.) is required.
- Demonstrated competency and experience in drug product development within the pharmaceutical industry is required.
- Successful work experience in a matrix organization is preferred.
- Good oral, written (good experience in writing of scientific reports and filing documentation) and presentation skills are essential.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusion workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.
Skills Desired
Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model
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What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
