Engineer I/II/III, Process Development at Moderna Therapeutics in Cambridge, Massachusetts

Job Description:

The Role:
Moderna is seeking a highly skilled and motivated process development Engineer within the Technical Development organization. This role will develop, scale-up, and transfer new and improved production processes for Moderna's first-in-class messenger RNA (mRNA) based medicines to enable our clinical supply and late stage development.

Moderna is developing first-in-class mRNA-based vaccines and therapeutics. The mRNA is packaged into lipid nanoparticles for storage and delivery. The Process Development group is focused on unit operations that are standard across the industry such as normal and tangential flow filtration and chromatographic purification. We are also designing scalable operations specifically invented to form our lipid nanoparticles, to encapsulate the mRNA, and to physically stabilize the particles. The person in this role will have the opportunity to design, optimize, and transfer these unit operations for scale-up and late-stage clinical supply. In addition, the person in this role will be part of a late-stage development team focused on process robustness/characterization, understanding product quality, and refining the control strategy.

Applicants should enjoy working in a fast-paced, dynamic, and innovative environment. Collaboration through cross-functional matrix teams and excellent communication skills are required. The candidate must have strong skills in designing and executing bioprocess experiments. Results will be presented to broader groups allowing exposure across the Technical Development organization.

We seek applicants that are proactive, enthusiastic, and show a passion for process development. Applicants should have exceptional time management and communications skills with a strong attention to detail. Previous experience with chromatography, nanoparticle formulations, filtration technologies, mixing technologies, tangential flow filtration, process robustness, process characterization, and design of experiments is preferred.

Here's What You'll Do:

• Design, execute, and analyze experiments for existing and novel process modes




• Define the process, the critical parameters, and the design space




• Create high throughput and automated experimental setups




• Lead experiments to confirm robust process performance across the control space




• Characterize nanoparticle properties through collaboration with the analytical team




• Prepare process descriptions, technical reports, communicate findings internally and externally, and present in cross-functional meetings




• Collect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups. Optimize current processes to ensure robust manufacturing of mRNA therapeutics

Here's What You'll Bring to the Table:

• BS or MS in Bio/Chemical Engineering, Bio/Chemistry, or closely related field




• BS with 3-8 years, or MS with 1-5 years of relevant industry experience in bioprocess development




• Hands-on experience with chromatography, ultrafiltration, normal flow filtration, and development of innovative unit operations




• 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




• Ability to thrive in a diverse and fast paced environment




• Excellent written and verbal communication skills




• Preferred: Experience with nanoparticle formulations




• Preferred: Familiarity with nucleic acid, protein, and/or lipid chemistry, enzyme kinetics, and analytical characterization of biomolecules




• Preferred: Hands-on experience with AKTA FPLC, Tangential flow filtration (TFF), and HPLC/UPLC instrumentation, JMP statistical software

Here's What We'll Bring to the Table:

• On-site subsidized cafeteria or catered lunches


• Company-provided iPhone


• Free parking, monthly subway pass or a subsidized commuter rail pass


• Free annual corporate membership to Bluebikes


• 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


• 16 weeks of 100% paid parental leave for all new parents


• 16 weeks 100% paid family caregiver leave


• 20 weeks 100% paid medical leave


• Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)


• Adoption assistance and discounts to local childcare centers, as well as access to care.com


• 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 (includes 2 floating holidays)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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.

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