Head, Drug Substance Process Development
Moderna is seeking the Head for mRNA Process Development to accomplish development of robust, scalable, and commercializable drug substance processes, enable manufacture of clinical materials to support drug development, design of larger scale facilities, and advance the science of mRNA medicines. 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 biologics/nucleic acid process development is required. Experience in the development of multiple clinical products with multiple phases of development, including leading to commercialization is essential. 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 CMC activities with toxicology and clinical development for regulatory submission is essential. Deep knowledge of cGMP and other relevant regulations is required. Experience with manufacturing facility design and operation is highly desired. This position has significant visibility and potential for growth in a dynamic organization seeking to enable the breakthrough opportunity of mRNA therapeutics.
- Manage all activities for process development of mRNA drug substance
- Build and lead a high performing team consisting of scientists and engineers
- Interface with internal and external (CMO) non-GMP and GMP manufacturing activities. Identify, manage and contribute to external contracts as required.
- Be the single point of contact for all Drug Substance process for all partners and therapeutic areas in the Moderna ecosystem
- Maintain accountability for project success and results delivery
- Establish strong bridges with internal groups of formulation development, analytical development, and GMP operations. Interact with other R&D groups (clinical/PK/PD/Tox) to advance the science of RNA vaccines and therapies
- Contribute to technical and strategic discussions to advance platforms and product candidates
- Communicate development progress and issue resolution
- Ph.D. with at least 15 years of industry experience in with at least 10 years biologics (or nucleic acids) purification process development.
- Strong foundation in biochemical engineering or related discipline. Academic training or subsequent work experience in the area of biophysics/biochemistry, biomolecular interactions, colloidal science, and related areas.
- A track record of achievement in product development, supporting clinical/commercial programs in biotech/pharma. Filing of INDs and BLAs.
- Proven ability to define, manage and maintain scientific business relationships and contract research / manufacturing agreements
- People management and organization development
- Exceptional written and oral communication
- Experience with nucleic acid or polysaccharide process development
- Experience defining and executing development based on QbD principles
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.