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Scientist Formulation Development
at Vertex
Boston, MA

Scientist Formulation Development
at Vertex
Boston, MA

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Description

Job Description:

Vertex is seeking a highly motivated and talented scientist to join our dynamic and high energy Formulation Development group in Boston, MA. As a member of our dedicated team you will be responsible for advancing parenteral formulations for small molecules from exploratory development through commercial line extension in a Quality by Design (QbD) environment. You will explore alternative approaches, develop strategies supporting regulatory submissions, and ensure optimization of processes.

Your Skills and Experience:

  • Hands-on experience developing various parenteral formulations and manufacturing processes, which include but not limited to IV solutions or suspensions for small molecules with poor aqueous solubility
  • Experience with technology transfer for a drug product manufacturing process to a 3rd party CMO, which might encompass development and scale up activities with subsequent GMP manufacture
  • Consistent track record of applying fundamental scientific and engineering principles to formulation design, development, and process understanding
  • Drive development activities working in a cross-functional environment
  • Application of statistical analyses

Key Responsibilities:

  • Explore different approaches to formulate a small molecule (e.g. cosolvent, in situ salt formation, nanoformulation) to enhance solubility and promote physicochemical stability of drug product. In addition, for the drug product fill-finish, activities might include understanding impacts of buffer type/ concentration, pH, and container closure on stability of the drug product.
  • Build a strategy for formulation and process development starting from preclinical through all clinical stages in support of corresponding regulatory submissions.
  • Deliver and oversee the optimization of formulation and process understanding through rational experimental design, thoughtful execution and clear data interpretation, with a heavily emphasis on statistical analysis.
  • Collaborate within CMC teams and actively contribute to deliverables and engage in team discussion on issue resolution. Serve as CMC project lead as needed.
  • Execute and oversee technical transfers, scale up and clinical manufacture at external drug-product GMP facilities.
  • Draft and review presentations related to formulation development activities and present to various management levels.
  • Author and review technical reports, regulatory filings, source documents, patents and external publications.
  • Accountable for troubleshooting and resolving high complexity formulation challenges.
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Qualification:

  • Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering or related discipline with at least 5 years of meaningful industry experience or MS with over 8 years of experience
  • Hands-on and industrial experience in development of parenteral formulations (focus on IV formulations) for small molecules with poor aqueous solubility.
  • Experience in drug product process technology transfer, scale up and working with contract research and/or manufacturing organization (CRO or CMO) with proven record of troubleshooting and analytical skills
  • Strong background in applying statistical approaches in the design and analysis of experiments and experience with Quality by Design (QbD)
  • Experience with early and late stage drug product development and regulatory filings (IND/CTA, NDA/MAA)
  • Strong verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities.

Preferred Qualifications:

  • Expertise with development of IV formulations for small molecules with poor aqueous solubility
  • Formulation development for preclinical and clinical studies with technology transfer and support regulatory submissions.


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