Formulation Senior Principal Scientist

Job Description

General Summary:

Vertex is seeking a talented individual contributor to join our Formulation Development Department in Boston, MA. We are looking for a candidate with a strong technical background and industrial experience in late-stage injectable drug product development of different product images (e.g., liquid, suspension or lyophilized drug products in glass vials, prefilled syringes, etc.) for different drug modalities (e.g., small molecules, synthetic peptides and oligonucleotides), using traditional (e.g., compounding-filtration-fill-finish) and/or advanced pharmaceutical manufacturing technologies (e.g., polymeric/lipid nanoparticle fabrication, etc.). The Formulation Senior Principal Research Scientist is a high impact cross-functional position and will play a central role in advancing transformative medicines through all development stages. The successful candidate must be able to work independently and collaborate in a fast-paced, integrated, multidisciplinary team environment. This position will be responsible for designing and implementing scientific studies to enable the formulation/process development and optimization, clinical material manufacturing, drug product registration campaign, quality by design (QbD) studies, and providing technical support for commercial validation of injectable drug products from formulation development perspectives.

Key Duties and Responsibilities:

• Execute and oversee technology transfers, scale up and GMP batch manufacture at CMOs, and manage relationships with external partners.

• Responsible for late-stage development activities that include but not limited to process optimization, design and execution of registration campaign, drug product sterilization method development and qualification such as sterile filtration and moist heat terminal sterilization, in-use studies, design and execution of QbD trials.

• Build strong cross-functional collaboration as the Formulation Lead representing Formulation Development in the cross-function CMC team and actively contribute to defined deliverables and milestones for programs across all phases of development.

• Communicate critical project information to various bodies including project teams and leadership clearly and concisely

• Author or contribute to technical documents including regulatory submissions, internal guidance, and scientific papers.

• Responsible for 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 a high level of expertise via relevant scientific and technical literature and proactively apply new ideas to research projects. Train other peers as assigned in areas of expertise.

Knowledge and Skills:

• Demonstrated scientific leadership and a proven track record of late-stage injectable drug product development in pharmaceutical/biotech industry

• Extensive experience in technology transfer, clinical supply manufacturing, and registration campaign of injectable drug products through close collaboration with CROs and CMOs

• In-depth knowledge in the development and validation of sterilization process for injectable drug products, including both moist heat sterilization and sterile filtration followed by aseptic processing

• In-depth knowledge of QbD principles and experience in application of QbD tools to injectable drug product late-stage development to enable commercial manufacturing

• Strong knowledge and experience in authoring formulation relevant CMC regulatory filings (e.g., IND/IMPD/NDA, etc.) and responses to regulatory agency's queries

• Proven scientific acumen with the ability to creatively seek resolutions to complex drug formulation or manufacturing process issues

• Ability to work in a fast-paced environment, manage priorities and deliver quality results on time and in a highly ethical and professional manner

• Excellent communication and organizational skills

Education and Experience:

• PhD in Pharmaceutical Sciences, Chemical Engineering, Material Science or related field and 6-8+ years' experience in industrial Pharmaceutical Development, Life Sciences, Engineering, or

• Master's Degree in Pharmaceutical Sciences, Chemical Engineering, Material Science or related field and 9+ years' experience in industrial Pharmaceutical Development, Life Sciences, Engineering, or

• Bachelor's Degree in Pharmaceutical Sciences, Chemical Engineering, Material Science or related field and 11+ years' experience in industrial Pharmaceutical Development, Life Sciences, Engineering

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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 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 ApplicationAssistance@vrtx.com