Sr. Director, DNA Process Development
Moderna is seeking the Sr. Director for DNA Process Development to accomplish development of robust, scalable, and commercializable DNA plasmid and other critical raw material (e.g. enzymes) 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.
Here's What You'll Do:
- Manage all activities for process development of DNA plasmid and enzymes
- Build and lead a high performing team consisting of scientists and engineers
- Interface with internal and external (CMO) non-GMP and GMP manufacturing activities.Help identify, manage and contribute to external contracts as required.
- Be the single point of contact for all biologic critical raw material processes
- Maintain accountability for project success and results delivery
- Establish strong bridges with internal groups of process development, 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
Here's What You'll Bring to the Table:
- 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
Here's What We'll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP.
- Flexible Spending Accounts for medical expenses and dependent care expenses.
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.