Engineer II/III, Drug Product Process Development
Moderna is developing first-in-class mRNA-based vaccines and therapeutics. The mRNA is packaged into lipid nanoparticles (LNP) for storage and delivery. Moderna's Drug Product Process Development group residing in the Technical Development organization, designs the processes for mRNA encapsulation into the LNP and subsequent downstream operations. These processes are optimized for robustness and transferred for scale-up and for production of clinical supply.
Moderna is seeking an Engineer II / III to join DPPD for a position based in Cambridge, MA. The person in this role will have the opportunity to design, optimize, and transfer LNP production and purification processes of the future. The incumbent will work on cross functional teams to integrate new technologies into the platform, to design stability into drug product formulations, and to characterize processes for later stage clinical readiness. This position will work closely with Analytical Development to ensure identification and control of all critical quality attributes and will work 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. The candidate must have strong skills in designing and executing experiments. Ideally the candidate will have relevant experience designing bioprocesses and implementing technologies such as: on-line analytics, process modelling, feedback control, continuous processing, and real-time release.
Here's What You'll Do:
- Design, execute, and analyze experiments to advance fundamental understanding of mRNA lipid nanoparticle synthesis and stabilization, including automating for high throughput, where applicable.
- Define and optimize the process, critical parameters, design space, and confirm robust performance of the manufacturing process; develop scale-down models where needed.
- Evaluate and scale-up existing and novel process modes.
- Characterize nanoparticle physicochemical properties through collaboration with the analytical team.
- Prepare process descriptions, technical reports, and communicate findings internally and externally as appropriate.
- Collect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups.
Here's What You'll Bring to the Table:
- BS a/o MS degree in Bio/Chemical Engineering, Bio/Chemistry, Pharmaceutical Science, or related field
- 3+ years of relevant industry experience developing biopharmaceuticals
- Hands on experience with chromatography, ultrafiltration, normal flow filtration, and development of innovative unit operations
- Experience with process scale-up / scale-down for novel biologics
- Working knowledge of statistical design of experiments (DoE) and analysis of multivariate data
- Experience with analytics and biophysical characterization of nanoparticles is a plus
- Knowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and product commercialization
- Knowledge of nucleic acid chemistry, lipid chemistry, and biology is a plus
- Ability to thrive in a diverse and fast paced environment
- Excellent written and verbal communication skills
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 appli