Parenteral Formulation Characterization, Sr. Principal Scientist

Job Description

General Summary:

Vertex is seeking a talented individual to join our Analytical Development Department in Boston, MA. We are looking for a candidate with both leadership skills and a strong technical experience in physiochemical/biophysical characterization of peptides, oligonucleotides, and small molecule drug substances and associated parenteral drug products (e.g., glass vials, prefilled syringes, aqueous liquid, lyophilized powder/cake, frozen solutions etc.) and advanced pharmaceutical drug delivery technologies (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 Analytical Development Senior Principal Research Scientist will collaborate closely with associate CMC functions and act as a subject matter expert in physiochemical and biophysical characterization of drug substances and parenteral drug products. This role will lead the physical and biophysical characterization of parenteral drug products and includes both establishing standard and developing novel characterization techniques for small molecule, peptide and oligonucleotide in complex parenteral dosage forms.

The successful candidate must be able to work independently and collaborate in a fast-paced, integrated, multidisciplinary team environment and be able to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams. The role will be involved in projects from exploratory development through various clinical stages to regulatory filing.

Key Duties And Responsibilities

• Lead and serve as the SME for the physicochemical and biophysical characterization of complex small molecule, peptide and oligonucleotide drug substances in injectable formulations.
• Identify and implement physicochemical and biophysical characterization techniques and methods in support of project and business needs.
• Collaborate within CMC technical team and actively contribute to defined deliverables and milestones, and proactively engage in team discussion on risk mitigation and issue resolution.
• Identify critical product attributes and develop analytical and characterization methods to meet regulatory requirements and to support the drug substance and drug product control strategy.
• Design and conduct development and stability studies in support of formulation and product image selection in collaboration with the cross functional technical team.
• Support validation activities of relevant analytical methods as needed.
• Interface with CROs as necessary for more complex techniques not established in-house.
• Draft and review presentations and reports relevant to analytical development activities and present to various management levels.
• Maintain knowledge of current trends in physicochemical characterization of complex small molecule, peptide and oligonucleotide drug substances in injectable drug products as well as associated global regulatory expectations. Train other peers as assigned in areas of expertise.

Knowledge And Skills

• 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 that provides strong technical guidance within the field of expertise.
• Demonstrated scientific leadership and a strong track record in translatable in physicochemical and biophysical characterization of complex peptide and oligonucleotide and injectable formulations by industry experience and/or external scientific publications and patents.
• Clear grasp of key physicochemical and biophysical characteristics that impact stability performance, quality and stability of complex peptide and oligonucleotide substances and products.
• In-depth theoretical knowledge and hands-on experience with physicochemical and biophysical characterization methods and techniques including, DSC, UV/VIS, CD, Florescence, NMR, IR, Raman, particle counting and sizing and others.
• Experience in authoring reports, methods and regulatory filings, and demonstrated working knowledge of applicable and emerging FDA, EMA ICH, and other regulatory requirements.
• Strong background in applying a sound scientific approach to experiment design and data analysis/interpretation.
• Demonstrated ability to develop solutions to complex problems and troubleshoot with creativity and innovation.
• Establish and lead academic / industrial partnerships to complement internal analytical efforts.
• Proven teamwork, leadership, and collaboration skills, with a demonstrated ability to interact with and influence diverse audiences.
• Excellent verbal