Job title: Expert Science and Technology
Job description: 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 wrt 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
EEO Statement Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum requirements WHAT YOU LL BRING TO THE ROLE:
M.Pharm with 8 to 10 years of experience or PhD in Science with focus on pharmaceutical sciences and technology (e.g. Pharmacy, Chemistry) with 4+ 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 injectable solutions and suspensions 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.
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
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.,
Location: Hyderabad, Telangana – Andhra Pradesh
Job date: Tue, 04 Jan 2022 08:53:14 GMT
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