DSRD Analytical and Formulations Principal Scientist

Groton, Connecticut
July 16 2021
Position Type
Full Time
Organization Type

The Analytical and Formulations Principal Scientist within Global Toxicology is part of a highly collaborative team that provides analytical and formulations expertise with direct and indirect contributions to laboratory-based activities in support of the portfolio and Drug Safety Research and Development (DSRD) goals. The Analytical and Formulations Principal Scientist provides management and oversight of Active Pharmaceutical Ingredient (API) and excipient requirements for internal and external studies, scientific review of protocols and reports, and study monitoring of external studies as needed. A close working relationship will be required with DSRD Team Leads (DSTL), other team representatives and representatives from Medicinal Chemistry, Pharmaceutical Sciences and other parts of the organization providing API and/or formulation and analytical expertise. The Analytical and Formulations Principal Scientist provides analytical and formulation guidance and expertise by contributing to the development of new procedures and methodology, metrics, troubleshooting, training, and harmonization of best processes.

  • Responsible for the global management of Test/Control Article (ie, API) and excipients; ordering, shipment coordination, tracking, obtaining, and reviewing the supporting documentation (eg, stability and handling documentation, CoA's) necessary for the conduct of internal and external DSRD studies.
  • Using technical expertise, outside sources (e.g .published literature and scientific databases), responsible for developing strategic plans for the formulations and analytical laboratories and identification of new methods and technologies.
  • Serves as subject matter expert and writes and/or contributes to the accuracy and completeness of analytical and formulation information in study protocols and reports based on study design discussions with Study Director (SD), DSTL and/or Management.
  • Responsible for analytical and formulations study planning and program startups for internal and external studies, interfacing with colleagues in Pharmaceutical Sciences, Medicinal Chemistry and Molecular Pharmaceutics as necessary.
  • Evaluates analytical and formulations capacity and workload and assigns study personnel.
  • Participates in technical transfer meetings with CROs as necessary.
  • Serves as primary contact for Global Toxicology Outsourcing for troubleshooting analytical and formulation issues and providing expertise at other internal sites and CRO's as necessary.
  • Develops and maintains analytical and formulations metrics utilized in making business decisions.
  • Serves as Principle Investigator overseeing the conduct of formulation concentration and/or particle size analysis on formulations prepared and utilized on studies conducted at CRO's.
  • Provide subject matter expertise, scientific training, oversight and/or mentoring to Analytical and Formulations personnel.
  • Applies technical and functional knowledge in order to resolve issues (eg. troubleshooting procedural/technique, equipment, regulatory, scheduling issues, communication).
  • Makes laboratory decisions using scientific judgment in order to solve complex issues.
  • Leads by example and instils a culture of continuous improvement within assigned work group as well as across Global Toxicology and DSRD.
  • Actively seeks new knowledge to identify and implement industry best practices for efficient, high quality study conduct to help ensure the team remains competitive and ahead of the industry standard.
  • Travel may be required.

  • Bachelor's degree in Chemistry, Pharmaceutical Sciences or related field with more than 12 years relevant experience
  • Master's degree in Chemistry, Pharmaceutical Sciences, or related field with more than 9 years relevant experience
  • PhD in Chemistry, Pharmaceutical Sciences, or related field with more than 4 years of relevant experience
  • Experience with Xybion Pristima
  • Knowledge of both Analytical HPLC and Formulations
  • Knowledge of Good Laboratory Practices
  • Experience in the conduct of Toxicology studies

Other Job Details:

Last Date to Apply for Job: July 23rd, 2021

Relocation support available


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