Associate Director of Analytical Development

Job Title: Associate Director, Analytical Development

Job Number: 36344

Location: , 

Job Description

Join a dynamic, preclinical stage, stealth biotech company advancing innovative mRNA and LNP technologies with broad potential therapeutic impact. We are looking for an Associate Director to lead the team responsible for the development of analytical methods to characterize oligonucleotide, mRNA, and lipid nanoparticle (LNP) based products. This individual will join an early-stage, multidisciplinary team of scientists and engineers and contribute to a variety of CMC activities in a highly collaborative environment. The right individual will play an enormous role helping realize the full potential of our platform technologies and programs. This is an opportunity to grow as a leader in the CMC group and to be a part of an exciting new company advancing a novel technology into the clinic.

Responsibilities

• Selecting, developing, and qualifying phase-appropriate test methods for the characterization of oligonucleotides, mRNA, and LNP products
• Interfacing with contract research organizations (CROs) and collaborators to lead method transfer and method qualification activities
• Characterize drug substance and drug product-related impurities
• Building and managing a high performing team of analytical scientists with a focus on quality results, career growth and culture
• Leveraging regulatory guidance and Quality-by-Design principles to develop robust analytical methods
• Guiding the development and lifecycle management of reference standards and control strategies
• Authoring SOPs, method and instrument qualification protocols, reports, certificates of analysis, and CMC sections of regulatory filings
• Serving as a subject matter expert and aiding in the investigation of out of specification or out of trend analytical results
• Planning, executing, documenting, and analyzing experiments, and presenting results thereof to a multidisciplinary team

Required Skills

• Bachelor’s or master’s degree (and 10+ years) or PhD (and 6+ years) experience in analytical development or quality control of mRNA/LNP, biologics, or gene therapy products
• A strong background in characterization of mRNA/LNP, biologics, or gene therapy products, including chromatographic, electrophoretic, spectroscopic, and biophysical characterization techniques
• Deep understanding of analytical methods required for development and characterization of oligonucleotide, mRNA and LNP based therapeutics
• Familiarity with state-of-the-art analytical tools and demonstrated ability to bring new tools to solve novel problems, and improve throughput, sensitivity, and/or robustness
• Experience transferring methods and managing relationships with CROs or CDMOs
• Excellent critical thinking abilities plus exceptional verbal and written communication skills
• Demonstrated ability to work independently and manage team members in a fast-paced R&D environment
• Experience in authoring and reviewing regulatory documents and preparing CMC sections

Our Ideal Candidate

• A motivated leader, with a passion for advancing novel technologies into the clinic
• A strong presenter and communicator, with the ability to work in a fast-paced and team-oriented environment
• Someone who is excited by a lean and changing organization, and by the opportunity to “wear multiple hats”
• A proven track record of taking pre-clinical programs from development to clinical proof of concept and beyond
• Someone who enjoys a transparent, outcomes-oriented, respectful, and innovative environment