Moderna is seeking a Senior Research Associate based at their Norwood, MA site. The individual in this role will focus on support Analytical Technical Transfer activities including method lifecycle projects (Acquisition, Qualification, Validation, Optimization and Troubleshooting). The individual will coordinate across teams to meet business objectives.
Heres What Youll Do:
Participate in Analytical Method Acquisitions and Method Qualification / Validation projects for HPLC/UHPLC/ GC/ Plate-based / DLS /MS/ (etc.) methods.
Author method qualification / validation protocols and reports.
Author Equipment and Method SOPs.
Execute method qualification / validation studies and perform statistical data analysis.
Manage method troubleshooting, remediation, change and optimization efforts in conjunction with Analytical Development and Quality Control.
Perform data entry, analysis, and review using electronic and paper systems.
Train Quality Control analysts to perform testing.
Provide technical support of contact laboratories.
Review of executed assay packages, in both paper and electronic formats. Includes review of chromatography data and other analytical outputs.
Other responsibilities as needed.
Heres What Youll Bring to the Table:
Minimum education required: Bachelors degree in a relevant scientific discipline
Minimum experience required: BS 5+ years / MS 3+ years, in a GMP laboratory setting focused on analytical chemistry.
Experience with early and late phase method qualifications / validation studies.
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
Strong technical writing skills.
Strong technical background in HPLC/ UHPLC / GC / Plate-Based / DLS/ MS (etc.) Instrumentation/ Software, and method acquisition / qualification / validation.
Proficiency with Microsoft Office Programs
Strong written and oral communication skills as well as organizational skills
Demonstrated ability to work effectively under established guidelines and instructions
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced 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 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.