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Job Description

As Vertex continues to expand its modalities in our commitment to serving patients, we are offering an exciting opportunity to join our Analytical Development team. We are actively seeking an expert in oligonucleotides, peptides, and conjugated therapeutics to play a pivotal role in our organization based in Boston. This newly created position will be responsible for all aspects of analytical development related to both drug substance and drug product components of the specified molecules. The successful candidate will contribute significantly to advancing a pipeline of products from the earliest stages of clinical development to marketing approval.

Key Responsibilities:

• Establish phase-appropriate analytical control strategies for drug product and drug substance, including specifications and retest/expiry assignment, across all stages of clinical development.
• Lead method development/validation, release, and stability testing of drug substance and drug product for oligonucleotide, peptide, and conjugated therapeutic projects.
• Collaborate with all CMC functions and CMC leadership to develop strategies and deliver on key objectives.
• Assume accountability for all Analytical Development CMC deliverables, including support of process and formulation activities.
• Manage timelines and work performed externally at CROs/CDMOs, ensuring adherence to global regulations and SOPs.
• Author Analytical Development CMC sections of regulatory filings and respond to information requests as appropriate.
• Define resources (internally and externally) needed to ensure the success of the projects.
• Mentor and train team members, ensuring compliance with regulations and SOPs.

Knowledge & Skills:

• Leadership experience in a matrixed analytical environment.
• CMC experience in pre-clinical and clinical development of oligonucleotides, peptides, and conjugated therapeutics.
• Prior Experience representing Analytical Development on cross-functional CMC project teams.
• Advanced technical knowledge and hands-on experience with analytical techniques used in oligonucleotide and peptide therapeutics, such as LC-MS, IP-RP-LC, IEX, sequencing, and peptide mapping.
• Exceptional organizational, communication, leadership, and project management skills.
• Knowledge and experience with cGMPs and regulatory guidelines

Education and Experience:

• Ph.D. with 7+ years, Master's degree with 10+ years, or BS degree with 12+ years of relevant experience within the pharmaceutical industry with an expertise in the development of oligonucleotides and peptides.

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