Role Description

Summary

The Scientist/Senior formulation Scientist will be responsible to support product development activities for NCE (new chemical entity) and LCM (life cycle management) projects in the small molecules space. The area of formulation research includes oral solids parenteral and topical dosage forms designed for animal administration.

The person hired for this position will work with global development teams in close collaboration with various functions such as analytical chemistry regulatory quality clinical manufacturing etc. Candidate will be responsible for supporting multiple projects and interfacing with various stakeholders across the organization as well as coordinate the product development activities with CROs and CDMOs. The candidate will also be responsible for authoring various documents such as product development reports CMC technical sections for regulatory submission manufacturing instructions protocols reports SOPs etc.

Responsibilities

• Support research and development of pharmaceutical drug products including oral solids parenteral and topical dosage forms.
• Perform earlystage formulation development to screen small molecule APIs.
• Execute preformulation and formulation development studies for pharmaceutical drug candidates.
• Support primary package development/screening studies.
• Perform drug product and raw material characterization and analysis independently.
• Investigate and define critical process parameters (CPPs) critical material attributes (CMAs) and critical quality attributes (CQAs).
• Identify and execute opportunities for process efficiency improvements to support sustainability.
• Conduct scaleup troubleshooting and derisking activities to support technology transfer from R&D to the global pilot and commercial manufacturing sites.
• Lead formulation sub teams and liaise with full development teams.
• Author formulation memos study protocols development reports and regulatory documents for filing and commercial launch.
• Coordinate with internal and external partners (CROs & CMOs) throughout the development process.
• Domestic and international business travel up to 10 of time.

Other desirable attributes

• Expertise in compaction simulation studies for oral solid dosage forms focusing on material characterization compressibility assessment and process optimization.
• Understanding of Quality by Design and Design of Experiments approaches and techniques.
• Familiarity with GMP VICH Pharmacopoeial Technical and Regulatory requirements in relation to animal health product development and manufacturing.
• Familiarity with manufacturing process development scaleup technology transfer to pilot/commercial scale.
• Sound understanding of biopharmaceutics IVIVC and biorelevant dissolution methods.
• Understands safety and considers it as an integral part of planning and performance of work.
• Sound understanding of GMP and knowledge of ICH Pharmacopeial requirements Technical and Regulatory requirements in relation to pharmaceutical product development and manufacturing.
• Experience with writing CMC technical sections and supporting postcommercial formulation vendor process and specification changes.
• Knowledge of Computational Fluid Dynamics (CFD) and its application in development and optimization of manufacturing processes for pharmaceutical products especially solid oral formulations.
• Recognizes the importance of relationships within the work group. Builds a sense of partnership with others in the work group to achieve results. Builds and maintains a strong network with people from other departments to enhance collaboration on assignments.

Qualifications

• Ph.D. in Pharmaceutical Sciences (Pharmaceutical Technology / Pharmaceutics) with 0 to 5 years of experience OR MS in Pharmaceutical Sciences (Pharmaceutical Technology / Pharmaceutics) with 10 years of formulation research experience in Pharmaceutical R&D.
• Firsthand experience in developing wide variety of challenging formulations with novel drug delivery approaches for taste masking solubility and bioavailability enhancement multiparticulate systems and extendedrelease dosage forms is desirable.

Full time

Regular

Colleague

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