Sr. Engineer II, Drug Substance Process Development
Moderna is developing first-in-class mRNA based vaccines and therapeutics. Moderna's Drug Substance Process Development (DSPD) group residing in the Technical Development organization, is designing new, robust and cost-effective mRNA production processes for transfer into manufacturing operations.
Moderna is seeking a Sr/Pr Development Scientist/Engineer to join DSPD for a position based at their Cambridge, MA site. The person in this role will have the opportunity to design the mRNA production and purification processes of the future. The incumbent will build and execute a long-term vision to create Moderna's next generation drug substance manufacturing platform including, but not limited to continuous processing, on-line analytics, process modelling, feedback control and real-time release. This position will work closely with Analytical Development to ensure identification and control of all critical quality attributes and with Manufacturing to deliver optimal process operability and economics.
The successful candidate must be able to work in a fast paced and highly dynamic environment and contribute to highly effective matrix teams. Ideally the candidate will have relevant experience designing and mathematically modelling bioprocesses including enzymatic reactions and chromatography, and will be able to drive projects independently.
Here's What You'll Do:
- Oversee development of next generation processes for production and purification of mRNA vaccines and therapeutics.
- Design, conduct and analyze experiments to define the process, critical parameters, design space, and confirm robust performance of the manufacturing process; develop scale-down models where needed.
- Collaborate with the analytical development teams in support of process development, as well as to drive new analytical method development where required for process characterization and online methods for Process Analytical Technology (PAT).
- Design a drug substance manufacturing process that is suited to automation and feedback control.
- Prepare process descriptions, technical reports, and communicate findings internally and externally as appropriate.
- Support the Manufacturing team as required to enable efficient technology transfer to the GMP manufacturing facility.
- You may supervise junior staff in process development activities.
Here's What You'll Bring to the Table:
- Minimum qualifications are a BS in Chemical Engineering, Chemistry, Biochemical Engineering, Biochemistry or closely related field, and 8-10 years relevant industry experience.
- Preferred Qualifications are a PhD in Chemical/Biochemical Engineering with 2-5 years of relevant experience in process development for large biomolecules (RNA, DNA, proteins, mAbs, viruses), as well as:
- Hands on experience with enzymatic reaction chemistry, column chromatography, UF/DF, and development of innovative unit operations.
- Experience with process scale-up / scale-down for purification of novel biologics
- Working knowledge of statistical design of experiments (DoE) and analysis of multivariate data
- Knowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and product commercialization
- Knowledge of nucleic acid chemistry and biology is a plus
- Ability to thrive in a diverse and fast paced environment
- Experience supervising technical staff
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.