Formulation Principal Research Scientist

Job Description

General Summary :

Vertex is seeking a talented individual to join our Formulation Development Department in Boston, MA. We are looking for a candidate with a strong technical background and experience in late-stage injectable drug product development of different product images (e.

g., glass vials, prefilled syringes, etc.) for different drug modalities such as small molecules and / or oligonucleotide, and good understanding of conventional (e.

g., aqueous liquid, lyophilized powder / cake, etc.) and advanced pharmaceutical drug delivery technologies dosage forms (e.

g., cyclodextrin inclusion complex, polymeric / lipid nanoparticles, etc.). The candidate must be a strong team player with excellent oral and written communication skills working in a complex cross-functional matrix.

The Formulation Principal Research Scientist is a high impact cross-functional position, making significant conceptual contributions across critical and diverse projects dedicated to advancing drug candidates from exploratory preclinical development through commercial phase in a Quality by Design (QbD) environment.

The successful candidate must be able to work independently and collaborate in a fast-paced, integrated, multidisciplinary team environment.

The role will be involved in projects from exploratory development through various clinical stages to regulatory filing.

This position will design and implement scientific studies to enable the process development, characterization and optimization, clinical manufacturing, and drug product registration campaign, and support commercial validation of parenteral / injectable drug products.

Key Duties and Responsibilities :

• Deliver and oversee the design, development, and optimization of drug product formulation and process through rational experimental planning and risk assessment, process characterization / modeling, thoughtful trial execution by Design of Experiments (DoE) approach and QbD principles, clear data analysis and interpretation with an emphasis on statistical analysis, and close cross-functional collaboration
• Responsible for late-stage development activities that will include development of optimal product pharmaceutical composition and robust scale-up process, selection of primary packaging system, compatibility assessment, and in-use characterization studies at different clinical phase.
• Collaborate within CMC team as the Formulation Lead and actively contribute to defined deliverables and milestones, and proactively engage in team discussion on risk mitigation and issue resolution.
• Execute and oversee technology transfers, scale up and clinical material manufacture at external parenteral drug product GMP facilities
• Draft and review presentations relevant to formulation development activities and present to various management levels
• Be responsible for quality of teams’ scientific output and maintaining a safe work environment
• Author and review technical reports, formulation preparation instructions, master batch record, regulatory filings, source documents, patents and external publications
• Lead drug product batch manufacturing related deviation investigations, change controls, and CAPAs using electronic Quality system
• Accountable for troubleshooting and resolving highly complex formulation and process challenges
• Maintain knowledge of current trends in parenteral drug product manufacturing processes, manufacturing equipment and single use systems as well as associated global regulatory expectations.

Train other peers as assigned in areas of expertise

Knowledge and Skills :

• Demonstrated scientific leadership and a strong track record in translatable injectable formulation development (e.g., sterile liquid, lyophilized drug product for injection) by industry experience and / or external scientific publications and patents
• In-depth knowledge in parenteral process development, optimization and control strategy including compounding, sterile filtration, aseptic process as well as terminal sterilization, ranging from laboratory scale (R&D) to pilot / production scale (GMP)
• Strong experience in technology transfer and working with CROs / CMOs for parenteral drug product development and GMP manufacture
• Experience in authoring regulatory filings, and demonstrated working knowledge of FDA, EMA ICH, and other regulatory (e.

g., MHRA, TGA, etc.) requirements for CMC.

• Strong background in applying and scientific and statistical approaches in DoE and data analysis / interpretation
• In-depth knowledge of QbD principles and experience in application of QbD tools to parenteral drug product development and manufacture
• Deep understanding of technical and operational aspects of late phase to commercial GMP processed parenteral drug product manufacturing
• Demonstrated ability to develop solutions to complex problems, and troubleshoot with creativity and innovation
• A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
• Proven teamwork, leadership, and collaboration skills, with a demonstrated ability to interact with and influence diverse audiences
• Excellent verbal, and written communication skills

Education and Experience :

• PhD in Pharmaceutical Sciences, Chemical Engineering, Material Science or related field and 4-7 years’ experience in Pharmaceutical Development, Life Sciences, Engineering or Academia, or
• Master's Degree in Pharmaceutical Sciences, Chemical Engineering, Material Science or related field and +7 years’ experience in Pharmaceutical Development, Life Sciences, Engineering or Academia, or
• Bachelor's Degree in Pharmaceutical Sciences, Chemical Engineering, Material Science or related field and +10 years’ experience in Pharmaceutical Development, Life Sciences, Engineering or Academia

Travel : up to 10%