Engineer III, Process Development at Moderna Therapeutics in Norwood, Massachusetts

Job Description:

The Role:

Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines. We are seeking a highly skilled and motivated process development engineer for our Technical Development organization. In this role, you will have the opportunity to develop and commercialize biological manufacturing processes. You will collaborate closely with cross-functional teams across CMC, Research and Development, GMP Production, Quality, and Analytical Development to develop and implement innovative processes and solutions. We are especially looking for talents with experiences in one or more of the following fields: technology transfers, process modeling and scale-up, QbD-principles, chromatography, filtration technologies, and/or tangential flow filtration.

In this role, multi-day domestic and/or international travel (up to 20%) should be expected to support process investigations, support technology transfer and provide Person-in-Plant (PiP) support for commercial batches.

Do you feel energized by working in a fast-paced and highly dynamic environment? Do you have first experience in bioprocess development? Are you passionate about cutting-edge digital biotech and next generation bioprocess development? Then join us in creating a new generation of transformative medicines for patients!

Here's What You'll Do:

• Oversee processes related to drug substance manufacturing for clinical trial products, as well as large scale manufacturing




• Serve as subject matter expert on novel and complex drug substance manufacturing processes at multiple scales




• Act as the sending unit for technology transfer for drug substance manufacturing processes, both internally and to external CMOs




• Serve as person-in-plant during GMP manufacturing activities, where applicable




• Ensure that assigned processes are cGMP compliant and are designed to meet the regulations of the U.S. FDA and other regulatory agencies as required




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




• Support investigations for deviations during GMP manufacturing and generate corresponding impact and risk assessments




• Lead operational excellence activities and proactive initiatives to improve current GMP manufacturing practices

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

• BS in Chemical Engineering, Chemistry, Biochemical Engineering, Biochemistry or closely related field, and 5-8 years relevant industry experience or an MS in a similar field with 2-5 years relevant industry experience.




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




• Working knowledge of bioprocess engineering principles, process modeling, and Design of Experiment (DoE) statistical tools.




• Knowledge of cGMP, ICH, regulatory guidelines and QbD-principles as they apply to risk management and product development




• Excellent communication, presentation, and writing skills




• Creative/innovative/problem solver




• Ability to thrive in fast paced and highly collaborative environment




• Preferred: Demonstrated background of providing technical support to GMP manufacturing processes, including support of process investigations and implementation of pro-active process modifications and corrective actions




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




• Preferred: Experience/education in pharmaceutical sciences and/or biotechnology process/product development.

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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