Position HR 112- Formulations Scientist
3 weeks ago
Position Summary
The formulation Scientist will be responsible for understanding small molecule chemistry, degradation pathways, characterization and stabilization techniques. The selected candidate will be supporting screening formulations for optimizing solubility and stability of drug candidates for ophthalmic and injectable drug products. Develop formulations for preclinical studies. Work with regulatory team in preparing PreIND meeting request and support IND and NDA submissions. Design and conduct pre-formulation, formulation development, process development and process optimization of parenteral and ophthalmic formulations. Design and develop robust, scalable formulations, manufacture prototype dosage forms, and conduct drug product process development and process optimization activities in-house. Conduct literature search for the assigned projects. Demonstrate scientific creativity, initiative and contribution to the team and company goals. The individual will also be responsible for designing and executing different laboratory experiments, making observations, performing data analysis and reporting results.
Requirements:Qualifications:
0-5 years of work experience in early or late stage formulation development of small molecules.
PhD or Master’s degree in Pharmaceutical sciences, chemical engineering or other related scientific disciplines.
Must be well organized, proactive and detail oriented.
Pharmaceutical development experience preferred but not required.
Demonstrated excellence in independently designing and conducting experiments and analyzing data
Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problems.
Understanding the mechanism of degradation and stabilization of molecules.
Experience in performing early phase formulation/process development of a sterile dosage forms for small molecules.
Strong verbal and written communication skills
Role and Responsibilities:
Exhibit strong scientific acumen, with ability to solve problems of medium/high complexity via independent planning, design, execution and interpretation of experiments
Support the development of robust scalable manufacturing processes and contribute to technology transfers to commercialization partners
Actively participate on development teams and interface with partner functional areas to drive project milestones as required. May represent functional area on project teams
Support the preparation and review of product development reports and related documents
Support regulatory filings for Pre-IND, IND, NDA and ANDAs
Maintain laboratory documentation in accordance to required scientific, regulatory and intellectual property requirements
Support the development and advance of sterile formulation best practices, new technology development and operational excellence
Possess strong organizational, written and verbal communication, and technical writing skills.
Demonstrate good interpersonal skills and the ability to work across multi-disciplinary teams
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
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