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
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.
· Good understanding of analytical methods (HPLC, Dissolution etc.)
*May require travel up to 15%