Job Review

The Senior Scientist is responsible for novel formulations and delivery technologies that meet regulatory and commercial requirements. The Sr. Scientist actively participates in all the phases of development including pre-formulation, process development scale-up and commercialization. This position requires exercising independent judgment to perform the responsibilities described herein.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by the employee.

Essential Duties and Responsibilities:

·         Assume project leader responsibility and independently design and conduct R&D experiments, assays, or procedures of considerable complexity with considerable discretion as to work details requiring complicated scientific analysis, operational planning and execution from pre formulation to commercial.

·         Identify scientific gaps, issues and opportunities of current project work

·         Contribute to the success of research initiatives applying a wide variety of scientific concepts and technologies to the development of new products impacting the portfolio

·         Analyze and interpret results, systems or procedures; troubleshoots failed experiments, assays or procedures and makes changes as appropriate.

·         Ensure that laboratory notebooks are consistently updated, audited, and well maintained

·         Propose programs to achieve IP-position relevant for future R&D

·         Author/review analytical protocols, SOPs, reports and related documentation.

·         Effectively collaborate with a fully integrated team to facilitate the success of projects (i.e., Quality, Manufacturing, BD)

Interpret and effectively communicate complex scientific findings in one-on-one discussions and department and functional meetings

Job Requirements

Education: Masters Degree in relevant disciplines pertaining to drug development (or equivalent with work experience); PhD preferred

Experience: At least 7 years of industry experience in pharmaceutical research and development

Other Knowledge, Skills and Abilities:

·         Product development experience with successful track record of leading programs resulting in FDA approval 

·         High proficiency in QbD both in design and full execution (sanitized real examples are required).

·         Preference for oral/liquid solid dosage forms with small and large molecules.

·         Solid knowledge of FDA and cGMP requirements.

·         Experience in preparing reports, literature reviews, and technical issues and their resolution affecting the product development.

·         Authoring formulation development and stability sections for regulatory submissions.

·         Strong results driven personality, excellent judgment, and motivation.

·         Maintain state-of-the-art scientific knowledge with solid experience in creating and securing IP.

·         Ability to clearly communicate, both verbally and in writing, to all levels of the organization.

·         Working in a cross-functional environment interacting with departments such as regulatory, quality, manufacturing, and project management.

·         Working with external clients and/or CDMO/CROs.

·         Flexibility to acquire additional competencies and skill sets as mandated by the changing needs of the organization.  

Preferred Qualifications:

·         Good understanding of analytical methods (HPLC, Dissolution etc.)

*May require travel up to 15%

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