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 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 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 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 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
• Master's 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:

$137,600 - $206,400

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

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

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 E-Verify 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 ...