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Scientist/Senior Scientist, Formulation
Job Description
DESCRIPTION
Summary of position
This is an opportunity to join a growing, dynamic team of formulation scientists and to play a critical role in driving the next generation of innovative products at Ironwood. The qualified candidate will be responsible for drug product development from lead optimization during drug discovery to late stage clinical development, manufacture of clinical supplies, and development of efficient and scalable manufacturing processes. Experience and/or knowledge of preclinical formulation support, characterization of solution and solid state properties of materials, formulation development, process selection and scale up, and contract research and manufacturing organization management will be important considerations for candidacy.
The individual in this role will be expected to:
Plan, design, carry out, and interpret laboratory experiments to properly characterize novel drug candidates (small molecules and/or peptides).
Apply formulation and manufacturing principles, theories and techniques to product development
Work closely with drug discovery teams to ensure timely and high quality support for preclinical studies
When needed, lead Formulation Research efforts in identification and evaluation of internal and external delivery technologies (such as oral bioavailability enhancement, targeted or controlled drug delivery) to enable development of Ironwood discovery candidates.
Author technical reports and CMC sections of the regulatory dossiers (INDs, IMPDs, NDAs etc.).
Represent the Formulation function in multidisciplinary project teams, work collaboratively to ensure project progression, and communicate formulation strategy and related challenges.
Work effectively with CMOs by providing technical oversight to ensure that Ironwood’s clinical manufacturing needs are met.
Requirements
PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry or related scientific field. A minimum of 3 years of industry experience.
Experience in drug product formulation, manufacturing process development and scale-up.
Strong fundamental understanding of physicochemical and biopharmaceutical properties and their importance in formulation design.
Working knowledge and know-how to support preclinical studies with variety of formulation approaches and delivery routes
Experience/know-how of technologies for solubility/bioavailability enhancement of poorly soluble candidates.
Working knowledge of methods and instrumentation used for the characterization of solution and solid state properties of materials.
Good communication, project management, and interpersonal skills
Effective and innovative problem solving
Company
Ironwood Pharmaceuticals, Inc.
Job Code
State or Province
Massachusetts
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