Principal Research Scientist, Formulations

Job Description

Formulation 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 Vertexs 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 invivo bioperformance using modeling tools. Additionally the candidate will lead the design development and implementation of various nonoral 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 biorelevant media) screens of small molecules of drug candidates
• Develop stable and bioavailable formulations for different stages of development (e.g. solution/suspensionbased formulations amorphous pharmaceutical systems into solid oral dosage forms parenteral etc.)
• Lead the design development and implementation of various nonoral formulations such as IV and Subcutaneous formulations
• Conduct preliminary solid form and salt screen for preclinical candidates. Handson 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 time

Required 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 nonoral IV and SQ for nonclinical study
• Handson experience in analytical techniques such as HPLC methods PXRD TGA DSC and particle size analyzer to enable evaluation of earlystage 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 multidisciplinary team under defined timelines
• GLP GMP and GxP experience Strong data analysis skills
• Excellent leadership teamwork and organizational skills

Education and Experience:

• PhD in pharmaceutical sciences chemistry chemical engineering materials sciences or related field and 4 to7 years experience in life sciences engineering or academia
• Masters Degree in pharmaceutical sciences chemistry chemical engineering materials sciences or related field and at least 7 years experience in life sciences engineering or academia

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an EVerify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at