Moderna is seeking a Sr Research Associate with expertise in technical writing for a position based at their Norwood, MA site.
The individual in this role will be responsible for authoring and driving change controls, authoring, and revising analytical method standard operating procedures, authoring technical reports / method qualification protocols and reports, method validation protocols and reports, CMC documents, and ensuring document standardization and compliance to relevant SOPs.
The successful candidate must have BS with at least 8 years of industry experience, or MS with at least 5 years of industry experience (Chemistry, Biochemistry, Molecular Biology, or related science), writing and/or performing analytical, molecular, biochemical, biophysical and/or cellular assays. Experience with Authoring method SOPs for QC laboratory, drafting CMC submission dossier sections/ regulatory content, technical reports, and leading change controls in quality management systems preferred.
Heres What Youll Do:
Monitor updates to compendial chapters and updating QC SOPs accordingly.
Drafting new SOPs, qualification and validation protocols and reports.
Authoring Quality Event (Change controls CAPAs, deviations) for method-related changes.
Periodic reviews of current Test Methods and SOPs
CMC Filing support
Heres What Youll Bring to the Table:
BS/MS (Chemistry, Biochemistry, Molecular Biology, or related science)
Previous technical writing experience
Experience with Veeva or similar quality documentation system.
Experience with analytical methods and cGMP lab workflows.
Ability to work independently and effectively in a highly dynamic environment
Excellent communication, presentation, and writing skills
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 winter shut down
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.