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Principal Investigator, Formulation Development

ID: 1590
Department: Formulation Development
Location: Cambridge Headquarters
# of Openings: 1


Functional area:  Formulation Development

Position description:  

It’s an exciting time for our business. After two decades of growth and innovation, in 2018 we announced our intent to create two focused, independent companies: Ironwood and “R&D Co.”:  This new way of doing business will enhance our agility and innovation and empower our employees to make a bigger impact on patients and on our industry than ever before.


R&D Co. will harness our pioneering work in cGMP pharmacology to advance its portfolio of differentiated sGC stimulators being evaluated for treatment of serious and orphan diseases. Following completion of the separation, the Principal Investigator, Formulation Development will be a part of R&D Co.


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



The responsibilities of the principal investigator include but are not limited to:


  • Ability to represent Formulation on CMC teams and 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, supervise the execution, 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.).  

  • 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.


Minimum Qualifications:

  • BS, MS, or PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry or related scientific field and 4+ years (9+ years for BS/MS) of industrial experience.

  • Experience in drug product formulation, manufacturing process development and scale-up.

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

  • Strong fundamental understanding of physicochemical and biopharmaceutical properties and their importance in formulation design.

  • Experience in managing drug product activities at CMOs

  • Strong communication, project management, and interpersonal skills.

  • Effective and innovative problem-solving skills

Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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