Engineer III, MST - PCV Drug Substance Tech Transfer
- Moderna, Inc.
- Norwood, MA
- Start date
- Mar 31, 2023
- Information Technology, Applications/Technical Support, Science/R&D, Pharmacology
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Genetown, Best Places to Work
This new role will be part of Modernas Manufacturing Science and Technology team responsible for technical transfer and new process implementation to ensure the robust End-to-End production of our new mRNA Personalized Cancer Vaccine (PCV). The individual will be responsible for GMP implementation of small scale bioprocessing (drug substance). The individual will work collaboratively with cross functional stakeholders such as Technical Development, Manufacturing, Regulatory, and Quality, to ensure all technical aspects of production are successfully implemented.
Heres What Youll Do:
Provide oversight and direction for technical support of small scale drug substance cGMP manufacturing including troubleshooting, process improvements and change controls.
Oversee technology transfer activities and implementation to ensure timely and successful tech transfer to enable right first time cGMP manufacturing.
Support process training for GMP operations and development of process understanding and expertise.
Lead cross functional projects teams tasked with platform improvement or building new manufacturing capabilities.
Communicate with site leadership to drive alignment of critical decisions, strategy, and risk mitigations.
Build strong relationships and work closely with technology development, CMC portfolio office, supply chain, reg CMC, analytical development, process engineering, quality, and manufacturing.
Author sections of regulatory filings and assist in change control management.
Heres What Youll Bring to the Table:
Biochemical engineer, chemical engineer, or biological/chemistry science degree with > 8 years of experience in the pharmaceutical or biotechnology industry. Advanced degree preferred (MS, Ph.D.)
Demonstrated knowledge of cGMPs and experience providing technical support in a cGMP manufacturing environment.
Demonstrated expertise bioprocessing including fermentation and purification of protein and/or nucleic acids. Expertise in at least one of the following areas: chromatography, membrane separations, fermentation, enzymatic reactions, and formulation.
Technical agility. The capability to manage diverse technical areas.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Preferred: Experience in biologics process development and scale up / scale down.
Preferred: Experience with single use bioprocessing technologies.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafter
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. 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 and approval 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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven 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 persons 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.
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company 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 and cardiovascular diseases, independently and with strategic collaborators.
mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”
Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
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