Parenteral Formulation Characterization, Principal Scientist
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: October 16, 2024
Job Description:
Parenteral Formulation Characterization, Principal
ScientistGeneral 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 DesignatedFlex 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 InformationVertex 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
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Keywords: Vertex Pharmaceuticals, Lynn , Parenteral Formulation Characterization, Principal Scientist, Other , Boston, Massachusetts
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