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Career Openings


Scientist, Formulation Development

ID: 685
Department: CMC Pharmaceutical Development
Location: HQ: Cambridge
# of Openings: 1

Description

Functional area: Formulation Development

 

Position description:

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, manufacturing process selection, development and scale up, and contract research and manufacturing organization management will be important considerations for candidacy.

 

Responsibilities:

  • Design, plan, 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 and develop the best possible phase appropriate formulations and manufacturing processes

  • Work closely with drug discovery teams to ensure timely and high-quality support for preclinical studies

  • Author technical reports and CMC sections of the regulatory dossiers (INDs, IMPDs, and NDAs etc.).  

  • Represent Formulation on CMC teams and work collaboratively to ensure project progression, and communicate Formulation Development strategy and related challenges.

  • Work effectively with CMOs by providing technical oversight to ensure that Ironwood’s clinical manufacturing needs are met.

 

Basic qualifications:

  • PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry or related scientific field with 5+ years of industrial 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.

  • Good communication, project management, and interpersonal skills

  • Effective and innovative problem solving skills

 

 

Preferred qualifications:

  • Experience in managing drug product activities at CMOs

  • Working knowledge and know-how to support preclinical studies with variety of formulation approaches and delivery routes

  • Experience with 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.

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.





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