We are seeking a highly skilled and motivated Engineer I in Drug Product Development, to work in a team developing Moderna’s sterile drug product processes and products that enable clinical and future commercial supply. The primary role for this position will be to support product concept development including formulation composition development, process development, method/validation development and scale-up work, with eventual ownership of experimental design and execution. The incumbent will support the development of compositions, aseptic fill/finish unit operations through the development and use of scale-down models, process characterization studies etc. The applicant will collaborate closely with Process development and Analytical development groups on innovative product and process development efforts. Applicants should have relevant pharmaceutical sciences related experience with various aspects of drug product development. The applicant should have exceptional ability to plan, execute and report, to communicate and collaborate, and requires strong attention to detail while working in a fast-paced, interdisciplinary environment.
Here’s What You’ll Do:
Support Moderna’s product development efforts with pharmaceutical sciences related studies such as formulation, composition, compatibility, CCI, E&L etc.
Conduct studies to support scale-up of drug product manufacturing (e.g. freeze/thaw, mixing, filling, filtration, lyophilization, transport etc).
Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes.
Provide support to drug product formulation innovation efforts.
Plan, organize and execute experiments (using DoE where possible) – prepare study protocols and summarize the development results with presentations and study reports.
Communicate and collaborate with various groups such as Process development and Analytical to execute experiments and compile data.
Support manufacturing with studies for process trouble-shooting and investigations.
Perform a range of routine and non-routine characterization techniques, including opacity testing, microscopy, particle sizing etc.
Develop processes suitable to ensure long-term stability of vialed drug product.
Maintain an up-to-date ELN with good documentation practices
Closely collaborate with multiple groups to generate innovative solutions to challenging formulation and process problems.
Here’s What You’ll Bring to the Table:
Education Qualifications – Bachelor’s Degree in on one of the following fields: Chemical Engineering, Biochemical or Biomedical Engineering, Pharmaceutical Sciences, or any related or sub‑disciplines of the above.
Relevant Experience: 0 – 2 years post Bachelor’s Degree.
Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment
Knowledge of statistical design of experiments (DoE) and analysis
Knowledge of nucleic acid chemistry and biology is a plus
Preferred: Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry
Preferred: Experience with nanoparticle formulation technology
Preferred: Knowledge of GMP compliance.
Candidate will be curious in exploring new paths for drug development, bold in proposing creative experimental designs and ideas. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes
Here’s What We’ll Bring to the Table:
On-site subsidized cafeteria or catered lunches
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)
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.