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Moderna is seeking a leader in Drug Product Development to accomplish translation of mRNA formulations and drug product processes into clinical materials to support drug development. The individual in this role will lead process development of clinical formulations for delivery of mRNA based on a broad set of approaches and technologies. He/she will balance internal effort with selection and management of outsourcing to CRO and CMO parties to fulfill development program needs. Broad knowledge of nucleic acid formulations, nanoparticle-based drug delivery, sterile products manufacture and general pharmaceutical product development is required. The successful candidate must have proven ability to meet development goals on aggressive timelines while having a record of effective collaboration with quality assurance and regulatory stakeholders. Experience in integrating non-clinical formulation work, toxicology and clinical feedback into robust dosage forms and processes for regulatory submission is essential. Deep knowledge of cGMP and other relevant regulation is required. Experience with pilot facility design and operation is desirable. This position has significant visibility and potential for growth in a dynamic organization seeking to enable the breakthrough opportunity of mRNA therapeutics.
Responsibilities
- Lead development of nucleic acid formulations for delivery of mRNA in the clinic
- Organize process and formulation efforts for clinical programs
- Identify, manage and contribute to external contracts as required
- Management of scientists and engineers internally and externally
- Maintain accountability for project success and results delivery
- Interact closely with internal R&D groups on studies of safety and efficacy (clinical/PK/PD/Tox)
- Contribute to technical and strategic discussions to advance platforms and product candidates
- Communicate development progress and issue resolution
Minimum Qualifications
- Ph.D. with >10 years of industry experience in formulation and process development
- Strong foundation in materials science or chemical engineering as applied to nanotechnologies
- A track record of achievement in product development, supporting clinical programs in biotech/pharma
- Proven ability to define, manage and maintain scientific business relationships and contract research / manufacturing agreements
- Exceptional written and oral communication
Preferred Qualifications
- Experience formulating nucleic acids for in vivo delivery, understanding of polyelectrolyte systems and polymer science related to nanoparticle formulations
- Expertise in process engineering of nanoparticles containing nucleic acids
- Awareness and understanding of adjacent areas in drug delivery and biologics
- Experience defining and executing development based on QbD principles
- A record of building and motivating teams that collaborate effectively
- Ability to inspire, mentor and develop staff across organizations
Competencies
- Commitment to Excellence in Innovation and Execution
- Results Orientation, Ability to Manage Performance
- Flexibility / Adaptability to Frequent Change
- Effective Communication
- Personal and Shared Accountability
- Talent Development
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Job Location -
Cambridge, Massachusetts, United States
- Position Type
- Full-Time/Regular