Parenteral Formulation Characterization, Principal Scientist

3 weeks ago

Boston, United States Vertex Pharmaceuticals Full time
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 a strong technical background and 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 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. The role 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
  • Collaborate within CMC technical team as the physiochemical and biophysical characterization SME and actively contribute to defined deliverables and milestones, and proactively engage in team discussion on risk mitigation and issue resolution.
  • In collaboration with the cross functional team 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.
  • Serve as the SME in 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.
  • In collaboration with the cross functional technical team propose, design and conduct development and stability studies in support of formulation and product image selection.
  • 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
  • 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.
  • Clear grasp of key physicochemical and biophysical characteristics that impact stability performance, quality and stability of complex peptide and oligonucleotide substances and products.
  • 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.
  • 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.
  • 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.
  • 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, Physical/Analytical Chemistry, Material Science or related field and 4-7 years’ experience in Pharmaceutical Development, Life Sciences, Engineering or Academia
  • Equivalent combination of education and experience will also be considered.
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 ApplicationAssistance@vrtx.com #J-18808-Ljbffr

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