We seek a highly skilled and motivated engineer to work in a team developing clinical and final dosage forms of Moderna's mRNA-Lipid Nanoparticle formulations. Primary area of responsibilities for this position will be to develop compositions that enable a stable product through exploration of liquid and solidified (lyophilized, spray dried) dosage forms. The engineer will also work with other members of the team to understand impact of aseptic fill finish unit operations on product characteristics and thus support process development and scale-up with ownership of experimental design and execution. Applicants should have knowledge and experience in formulation development, aseptic fill finish processes, and a good background in biochemistry and biophysics as it pertains to biologics. Knowledge of lipid-based delivery systems and/or experience with late stage development activities such as driving extractabes/leachables programs is a plus. This position requires exceptional project management, leadership, collaboration, communications skills with a strong attention to detail, as well as an ability to work in a fast-paced, interdisciplinary environment. This position has significant visibility and potential for growth in a dynamic team.
Here's What You'll Do:
Perform composition development studies to help to stabilize mRNA/lipid nanoparticle formulations in liquid and solidified states.
Design and conduct experiments to support aseptic fill / finish unit operations with scale-up and technology transfer.
Develop suitable compositions and processes to ensure long-term stability of formulated bulk and final drug products.
Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes.
Identify, motivate and install new techniques and technologies to improve efficiency in conducting above tasks.
Summarize the development results with tech reports.
Provide support to drug product formulation innovation efforts
Support Analytical Development teams to develop suitable methods
Support manufacturing for process trouble-shooting and investigations.
Here's What You'll Bring to the Table:
Ph.D. with 2 to 4 years or M.S. with 5 to 8 years of related industry experience in Biochemical Engineering, Chemical Engineering, or Pharmaceutical Sciences.
Extensive experience with formulation development (liquid, solidified - lyophilized / spray dried), drug delivery, nanoparticles development,
Experience with use of analytical and biophysical techniques including HPLC, DLS, Particle sizing and counting, Z-potential, FTIR, DSC, DSF etc.
Experience with support of late-stage development activities such as aseptic process simulation and characterization, extractables/leachables, shipping etc.
Experience with statistical design of experiments (DoE) and analysis.
Good knowledge of biochemistry and biophysical aspects of biologics
Knowledge of nucleic acid chemistry and biology
Knowledge of current practices and trends in disposable sterile technologies.
Knowledge of GMP regulations and GLP compliance, Process Validation/Qualification principles, and aseptic processing principles.
Preferred: Experience with lipid nanoparticle formulations
Preferred: Process tech transfer experience to internal/external manufacturing sites
Preferred: Experience with regulatory filings
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)
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.