Moderna is seeking a Quality Control Bioassay Sr. Specialist based at their Norwood laboratory, MA site. The individual in this role will review data generated by Bioassay associates in support of the Release of Personalized Cancer vaccine program product lots. This role may support special projects as needed. This position will be 12-h Day Shift.
Here's What You'll Do:
Here's What You'll Bring to the Table:
- Performs routine Bioassay data review and reporting of data generated by the following: electrophoresis, PCR, qPCR, Sequencing, cell-based assays, etc.
- Ensures timely and successful execution of the assigned data management tasks
- Communicate the OOS/OOT/OOE/LE/Deviation cases to quality event investigation team promptly to ensure the bioassay lab complies with investigation/deviation SOP procedures. Support the Support the investigation activities. Follow up and follow through the investigation closure to approve the final data in LIMS.
- Supports Troubleshooting of methods and equipment.
- Performs data entry and supports trending and analysis
- Participates in project meetings to provide status updates to stakeholders
- Provides communication of risk and mitigation for all data management related deliverables
- Assist in FDA and Quality audits that involve data management
- Defining data review requirements and processes to ensure delivery of highest quality of data
- Complete and maintain cGMP documentation (electronic and Hard Copy) for work performed.
- Support authoring quality systems records such as deviations, change controls, CAPAs
- Establish and maintain a safe working environment
- Minimum education required: Bachelor's degree in a relevant scientific discipline
- Minimum experience required: 5+ years (2+ years of experience with Masters) in a laboratory setting with focus in analytical chemistry
- A good understanding of the clinical research life cycle process, knowledge in pharmaceutical data management environment.
- Minimum skills required:
- Technical writing
- Proficiency with Microsoft Office Programs
- Familiarity with electronic databases (e.g. LIMS, SAP, LMS)
- Practical working knowledge of HPLC/ UPLC and related software.
- Strong written and oral communication skills as well as organizational skills
- Knowledge of industry standards and guidelines
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment
- 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.About Moderna
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 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.