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Associate Director, Formulation Development

Ironwood Pharmaceuticals


Location:
Cambridge, Massachusetts 02142
Date:
11/02/2017
2017-11-022017-12-02
Job Type:
Employee
Job Status:
Full Time
Ironwood Pharmaceuticals
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Job Details

Position description:

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.  We’re focused on transforming knowledge into medicines that make a difference for patients, creating value that will inspire the continued support of our fellow shareholders, and building a team that passionately pursues excellence. We are developing first and second in class molecules with a focus to deliver the drug to the target site, making this a unique opportunity in Formulation Development.  Achieving these goals is incredibly difficult, and we’re looking for people who are up to, and inspired by, the challenge.

 

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, cross-functional team experience/leadership and contract research and manufacturing organization management will be important considerations for candidacy.

 

Responsibilities:

  • Lead CMC teams and represent Pharmaceutical Development in multidisciplinary project teams, work collaboratively to ensure project progression, and communicate Formulation/Pharmaceutical Development strategy and related challenges.

  • 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 and develop the best possible phase appropriate formulations

  • 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.).  

  • Supervise formulation scientists focused on formulation and process development.

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

Requirements

Minimum Requirements:

  • PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry or related scientific field with 10-+ 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.

  • Experience in leadership of interdisciplinary (Formulation) and multidisciplinary (CMC) teams

  • Experience in managing drug product activities at CMOs

  • Experience with technologies for solubility/bioavailability enhancement of poorly soluble candidates.

  • Good communication, project management, and interpersonal skills

  • Effective and innovative problem solving skills

 

Preferred  Qualifications

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

  • Working knowledge of methods and instrumentation used for the characterization of solution and solid state properties of materials.

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