Engineer III, Drug Product Process Development
You will join a tightly-knit cross-functional team to apply sound process engineering approaches to the continued improvement of Moderna's mRNA nanoparticle formulation processes. Key areas of focus will be process scale-up/scale-down and technology transfer into GMP manufacturing facilities.
You will establish robust unit operations and probe process design spaces to define process control strategies that facilitate the commercial scale manufacture of mRNA drug products in several therapeutic categories. Expect frequent technical and logistical challenges that will inspire you to operate outside of your comfort zone. Expect unbridled collaboration support from your colleagues as you assimilate the process and analytical insights needed to be successful.
We seek proactive and enthusiastic team members with a track record of pivotal process development accomplishments derived from heightened attention to detail.
Previous experience with nanoparticle formulations, tangential and normal flow filtration technologies, and the scaling of mixing operations is preferred. Familiarity with Quality-by-Design principles, Good Manufacturing Practices and internal and external process technology transfer is also preferred.
Here's What You'll Do:
- Design and execute experiments to interrogate process performance.
- Work in teams and individually with little direct supervision.
- This role may include supervisory responsibility for a high-performing team.
- Design and implement processes (and potentially novel equipment) to enable scale up of mRNA drug product manufacturing.
- Evaluate and establish process design space using Quality-by-Design principles.
- Communicate with cross-functional counterparts and/or CMO's
- Enable process transfer to internal or external manufacturing organizations and suppliers.
Here's What You'll Bring to the Table:
- BS with 5+ years or MS with 2+ years of biopharma process development/engineering industry experience and a degree in Chemical Engineering, Biomedical Engineering or related field
- A solid practical background in standard bioprocess unit operations (e.g. mixing, NFF/TFF, chromatography)
- Mechanical aptitude
- Strong familiarity with Good Manufacturing Practices.
- Experience in Phase 1, 2 and 3 process development is strongly preferred.
- Outstanding communication skills (verbal and written).
- Ability to manage multiple projects in a fast-paced environment.
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
- Experience working with process technology transfers (internal and with CMOs) is preferred.
- Experience with continuous process strategies and PAT are also preferred.
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.