The Head, Analytical Development will be an integrated member of Process Development group whose work enables product / process / formulation development, QC testing & characterization of products; and provides key information in support of CMC regulatory submissions. This job reports to the VP, Process Development. This person will initially lead a small group of Analytical Development Specialists.
• Lead identification of mRNA analytical and development of analytical schemes for research and cGMP use, becoming expert in all facets of the science of modified mRNA’s, their uses and properties
• In conjunction with stakeholders, develop the strategy for internal versus external analytical activities, and be responsible for leading/driving the various efforts
• Lead development and qualification of analytical methods for raw material, in-process, drug substance and drug product release, characterization, and stability testing; perform qualification studies on cGMP assays (i.e., biophysical, biochemical, sequencing, bioassays, and cell based assays)
• Conduct analytical transfers to CRO(s) for preclinical and clinical phase GMP testing, and support process technology transfer to cGMP CMOs
• As needed, lead development of analytical tests for preclinical and human clinical samples
• Lead product and impurity characterization, balancing in-house and external capabilities, and interfacing with contract organizations and collaborators
• Deliver technical reports and documents in preparation for regulatory submissions
• Recruit, manage, and motivate direct reports as well as academic consultants to efficiently and effectively deliver on goals
• Build a world-class analytical team that is expert in all aspects of long RNA molecules and their properties
Why join Moderna Therapeutics:
Moderna Therapeutics is pioneering messenger RNA therapeutics™, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn active intracellularly or secreted. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate including 200 patent applications with 10,000 claims ranging from novel nucleotide chemistries to specific drug compositions. The company plans to develop and commercialize its innovative mRNA drugs—initially for rare diseases and oncology—while partnering drug candidates in other therapeutic areas in order to rapidly deliver this innovation to patients.
Based in Cambridge, Massachusetts, Moderna is privately held and was founded in 2010 by Flagship VentureLabs in association with leading scientists from Harvard University and Massachusetts Institute of Technology.
Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Visit http://modernatx.com/revolution to apply.
• Ph.D. in analytical chemistry or related discipline with 10+ years of pharmaceutical / biotechnology industry experience or MS with 15+ years relevant experience
• Strong experience in analytical sciences of large molecules and/or aptamers.
• In-depth and hands-on industry experience with developing a broad range of analytical methodologies for evaluation of biological macromolecules (proteins, DNA, RNA) with demonstrated ability to identify and apply novel technologies for the study of macromolecules
• Demonstrated success in transferring robust analytical methods and creatively delivering analytical solutions for elucidation of structure and trace impurity identification generated during manufacture of complex molecules
• Technical skills should include: DNA/RNA analysis (e.g. sequencing, PCR), various HPLC modes and their principles, mass spectrometry, electrophoretic methods (including CE), immunoassays, protein chemistry, and biophysical techniques
• Understanding of molecular biology tools for characterizing large RNA
• Successful track record working with therapeutics from development to clinical stage
• Familiarity with ICH and regulatory guidelines as applied to analytical and stability aspects
• Ability to prioritize in a fast paced environment
• Learning agility, critical thinking, and drive to bring innovation and efficiency to meet company objectives
• Team Leadership
• Results Orientation
• Adaptability to Change
• External Perspective
• Talent Development
• Effective Communication (verbal & written)