Engineer III, MST Clinical Drug Substance
- Moderna, Inc.
- Norwood, MA
- Start date
- Mar 31, 2023
- Clinical, Clinical Research, Science/R&D, Pharmacology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Genetown, Best Places to Work
This role will be part of Modernas Manufacturing Science and Technology team responsible for operational support through complex deviation investigations and CAPA writing with the use of data analysis for producing high quality mRNA-based medicines for commercial production and evaluation in human clinical trials. This individual will be support process data entry, data mining/analysis and routine department level metrics update. This individual will work collaboratively with cross functional stakeholders such as Technical Development, Manufacturing, Regulatory, and Quality, to facilitate effective deviation investigations and successful implementation of corrective actions.
Heres What Youll Do:
Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and deviations
Lead cross functional teams to drive complex investigation close outs, determine root causes and implement appropriate corrective and preventive actions (CAPA)
Conduct document revisions and/or document management including Technology Transfer document and manufacturing procedures
Generate technical memos and reports in support of investigations for understanding impact to product
Maintain quality event database for MST deliverables and lead meetings to facilitate timely closures
Support process data entry into data analytics software (Statistica or similar) and analysis for routine reporting of process performance
Work with MST data team for continuous improvement of the data collection/entry structure to drive more automated/rapid analytics
Follow-up on requests, issues, and projects and report statuses to manager/ working teams
May perform metric trending
Heres What Youll Bring to the Table:
Bachelor's Degree with 5-8 years of experience in biopharmaceutical operations or a Masters
Degree with 2-5 years biopharmaceutical industry experience; Degree in Biochemical, Chemical or Biochemistry preferred.
Demonstrated knowledge of cGMPs and experience in providing technical support in a cGMP manufacturing environment. Knowledge of bioprocessing including purification of protein and/or nucleic acids preferred.
Demonstrated knowledge of quality systems and technical tools to drive investigations, root cause analysis and CAPAs.
Knowledge of statistical software such as Statistica, Spotfire, JMP preferred.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
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.#LI-PL1
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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