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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 talented individual to join our Formulation Development group in Boston, MA. Formulation Development group is a fast paced and high energy environment.
We are looking for a candidate with a strong background in physical chemistry and good understanding of material properties. The candidate will work with other scientists dedicated to advance drug candidates from exploratory development through commercial line extension in a Quality by Design (QbD) environment using lab based and computational tools to design and select dosage forms and manufacturing process. The candidate must be a strong team player with excellent communication skills working in a complex cross-functional matrix. The candidate must be able to work independently and take initiative. The Scientist II must be able to adapt to new and multiple projects, effectively ensuring alignment with corporate goals. The candidate must be intellectually curious and show resilience in solving complex problems. This candidate will show the courage to take risks and follow through to completion. The Scientist II commands a broad perspective and a deep knowledge of related disciplines and possesses diverse project experience and a broad knowledge of relevant literature and regulatory compliance.

Key Responsibilities:
  • Develop dosage forms for clinical and commercial use
  • Develop stable and bioavailable formulations for different stages of development (e.g. solution/suspension based formulations, amorphous pharmaceutical systems into solid oral dosage forms, parenterals etc.)
  • Design and perform elaborate and technically challenging experiments in compliance with applicable GxP regulations and SOPs
  • Generate data for project progression and regulatory filings, conduct optimization and process scale up studies.
  • Interpret complicated, multidimensional data and make recommendation on new processes and development directions
  • Perform advanced, complex experimental troubleshooting and methods development
  • Timely document integrated experimental outcomes in presentations and research reports and present data to senior management
  • Contributes substantively to patent and publication preparation
  • Keep abreast with scientific literature and champion relevant emerging technology in his/her field of expertise
  • Transfer of technical knowledge to contract research sites (CRO) for onsite clinical preparations
  • Oversight of outsourcing activities such as scale-up and technology transfer to contract manufacturing sites (CMO) partners for clinical trial manufacture externally as well as support clinical trial material manufacture within Vertex
  • Multi-task to effectively manage his/her efforts on multiple activities and/or projects and coordinate with other Vertex groups (such as Analytical Development, Materials Discovery and Characterization, Supply Chain Management, Quality Assurance etc.) to ensure that Clinical Trial Materials are produced in a timely manner
  • May supervise other Pharmaceutical Sciences staff and would be responsible for quality, timeliness and accuracy of work done of others
#LI-BS1

Qualification:

Ph.D. (or equivalent degree) and 2-5 years of productive, relevant post-doctoral work experience, orM.S. (or equivalent degree) and 5+ years of productive, relevant work experience
  • Sound knowledge of pharmaceutical and engineering principles in the solid dosage form development for both clinical and commercial scales
  • Hands on experience with formulation techniques, processing equipment, and unit operations at both the laboratory and clinical manufacturing scales.
    - Strong math skills particularly as applied to material/energy balances, and intermediate applied statistical analysis
    - Strong technical writing skills
    - Excellent verbal and written communication skills
  • Successful and efficient multitasking and working on a few projects concurrently
  • Detail-oriented
Preferred Qualifications:
  • Direct experience working with CMOs is a plus
  • Understanding of QbD and experience with regulatory filings is a plus
  • Experience working with small molecule new chemical entities (NCEs) and exposure to early phase formulation development activities
  • Experience with a range of dosage forms, including liquids, solids and oral. Experience with formulation development of poorly soluble compounds would be advantageous
  • Proven experience managing the scale-up and manufacturing of solid oral dosage forms
  • Proven ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to preformulation and formulation development, using a rational, scientific approach.
  • Strong data analysis skills
  • A history of success working in environments defined by innovation and initiative
  • Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines
  • Excellent leadership, teamwork and organizational skills
  • Solid verbal and written communication skills
  • GLP, GMP, GxP experience

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