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Novartis

Senior Expert, Chemical Pharmaceutical Profiling (CPP) Project Leader

Hyderabad, India

Summary

Novartis is looking for a highly motivated, experienced, and team-oriented individual for an opportunity to lead multiple projects for assessing the developability of new chemical entities (NCE's) destined for various routes of delivery and to participate in cross-functional teams to select molecules that can be successfully developed. The ideal individual for this role should exhibit exceptional leadership skills and possess a vision for creating an innovative discovery pharmaceutics support team working closely with pharmacokinetic, chemistry, tox, and pharmacology colleagues. The role includes using conventional and high throughput technologies to provide formulation data with an emphasis on solid state profiling, while utilizing very small amounts of drug substance. A special emphasis on early assessment of physiochemical properties and excipient compatibility will be required. The individual will also guide a team who will develop formulations for pharmacology and toxicology studies and identify a formulation principle for first in human "proof of concept" studies using small amount of material and faster turnaround of time to expedite molecule faster into clinic working with CRO/CMO's and internal teams.This position requires strong technical skills in physical chemical characterization, formulation, and biopharmaceutics as well as experience in selecting salt, co-crystal and polymorph screening processes. The candidate should be an expert in preclinical drug development and influencing project leader who can influence his/her research teams to ensure the right biopharmaceutical properties are present in given NCE prior to selection for development. The individual should possess strong knowledge of IVIVCs, G+ modeling, and various other early-stage development tools. The candidate will work very closely with novel drug delivery/innovation, digital, and early phase excellence teams within research and development line functions.

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About the Role

Additional Responsibilities include:

- Design, plan and perform scientific experiments and contribute to project-related scientific/technical activities (e.g., interpret results, evaluate data, draw relevant conclusions, and write/review reports).

- Provide efficient and robust processes for the manufacturing and/or analysis of drug products.

- Participate in sub-teams and fulfill all tasks and responsibilities related to own discipline.

- Interact/collaborate with research and/or other line functions to facilitate transfer of knowledge and deliveries of drug substance (form) and/or drug product.

- Contribute to evaluation of new scientific technologies and various innovative initiatives within the team.

- Utilize complex tools/equipment, lab automation tools and specialized facilities.

- Report and present scientific/technical results internally and contribute to publications, presentations and patents.

- Accountable and responsible for selecting NCE and its developability with mitigation plan on challenges/issue working with Mat Sci, DPPL and Biopharm expert

- Accountable for not delaying any PK, PD and tox studies due to physical form or formulation principle

  • Passion for being in the lab and work on speedy request of PK, PD formulation to avoid delays in studies

Minimum Requirements

Ph.D. in pharmaceutical sciences, chemistry and/or chemical engineering with 10+ years of industrial experience. Or

M.S in pharmaceutical sciences, chemistry and/or chemical engineering with 15+ years of industrial experience

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Division
Development

Business Unit
Pharmaceuticals

Location
India

Site
Hyderabad (Office)

Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area
Data Science

Job Type
Full time

Employment Type
Regular

Shift Work
No

Client-provided location(s): Hyderabad, Telangana, India
Job ID: Novartis-REQ-10002717
Employment Type: Full Time