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Principal Research Scientist, Formulations - San Diego California
Company: Vertex Pharmaceuticals Inc (US)
Location: San Diego, California
Posted On: 05/07/2025
Principal Research Scientist, Formulations page is loadedPrincipal Research Scientist, FormulationsApply locations San Diego, CA time type Full time posted on Posted 3 Days Ago job requisition id REQ-25296Job DescriptionFormulation Development at Vertex seeks a dedicated scientist to join a San Diego based team whose goal is to discover, develop, and commercialize therapies for patients with serious diseases. As a member of Formulation Development team, this role will support to develop preformulations of small molecule chemical entities to support PK, pharmacology, and toxicology studies at our San Diego site. The preformulation function is part of the global Formulation Development organization, a critical R&D function enabling the manufacturing of dosage forms along the complete development timeline from molecule selection to commercial.The primary responsibility for this position is to enable candidate selection within Vertex's promising pipeline of small molecules. The candidate will be responsible for exploring the form and formulation space for supporting a variety of preclinical studies to advance molecules to the clinic. The candidate is expected to help lay the foundations for future clinical development by successfully executing developability assessments and robust experimental physicochemical characterization of molecules and prediction of in-vivo bioperformance using modeling tools. Additionally, the candidate will lead the design, development, and implementation of various non-oral formulations such as IV and Subcutaneous formulations and their workflows within the formulation development team.The candidate will collaborate extensively with colleagues in discovery biology, chemistry, DMPK, and CMC functions. The ideal candidate has mastered the fundamentals of chemistry and physics and has direct experience in a research laboratory The candidate must comfortably take the initiative, be curious, and show resilience in solving complex problems.Key Responsibilities: - Deliver and oversee the optimization of formulation and process understanding through rationale experimental planning, thoughtful execution and clear data interpretation, with a heavily emphasis on statistical analysis
- Collaborate within CMC teams as the Preformulation lead and actively contribute to deliverables and engage in team discussion on issue resolution.
- Draft and review presentations relevant to formulation development activities and present to various management levels
- Conduct preliminary physicochemical properties (e.g., solubility, and stability in bio-relevant media) screens of small molecules of drug candidates
- Develop stable and bioavailable formulations for different stages of development (e.g. solution/suspension-based formulations, amorphous pharmaceutical systems into solid oral dosage forms, parenteral, etc.)
- Lead the design, development and implementation of various non-oral formulations such as IV and Subcutaneous formulations
- Conduct preliminary solid form and salt screen for preclinical candidates. Hands-on knowledge in form and salt selection methods
- Designs and performs technically challenging experiments in compliance with applicable regulations and SOPs
- Interprets complicated, multidimensional data and makes recommendations on new processes and development directions
- Performs relatively advanced experimental troubleshooting and methods development
- Accountable for troubleshooting and resolving highly complexity nonclinical formulation challenges
- Successful and efficient multitasking and working as part of a multidisciplinary team that works within defined timelines
- May supervise other Formulation Development staff and may be responsible for quality, timeliness and accuracy of work done of others
- Author and review technical reports, toxicity protocols, source documents, patents and external publications
- Source relevant scientific literature within field and surveys broadly beyond own discipline/field
- Contributes to patent and publication preparation
- Comply with all relevant ethical, safety, and training procedure.
- Excellent verbal and written communication skills
- Maintain accurate and complete laboratory notebook capturing protocols, results, and observations in real timeRequired Knowledge and Skills:
- Demonstrated ability to apply advanced principles of pharmaceutics, physical and organic chemistry, thermodynamics, and materials science, to preformulation and formulation development, using a rational, scientific approach.
- Strong background in applying statistical approaches in the design and analysis of experiments and translates to predictive modeling
- Experience working with small molecule new chemical entities (NCEs) and exposure to preformulation and early phase formulation development activities
- Experience with formulation development of poorly soluble compounds
- Experience with a range of dosage forms, including solution and suspension for oral dosing and non-oral IV and SQ for non-clinical study
- Hands-on experience in analytical techniques such as HPLC methods, PXRD, TGA, DSC, and particle size analyzer to enable evaluation of early-stage discovery compounds
- Hands on experience with formulation techniques, and processing equipment, both the laboratory and external CROs
- Familiarity with solid and liquid handling systems (e.g., ChemSpeed, and Hamiliton, etc.).
- Broad perspective and a deep knowledge of related disciplines and possesses diverse project experience and a broad knowledge of relevant literature and regulatory compliance
- Demonstrated ability to develop solutions to complex problems with creativity and innovation.
- Experience in leading technical teams
- Proven teamwork, leadership and collaboration skills, with a demonstrated ability to interact with and influence diverse audiences
- Strong technical writing, verbal and written communication skills
- Successful and efficient multitasking and working on a few projects concurrently
- Direct experience working with CMOs is a plus
- Understanding of QbD and experience with regulatory filings is a plus
- 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
- GLP, GMP and GxP experience --- Strong data analysis skills
- Excellent leadership, teamwork and organizational skillsEducation and Experience:
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