The RoleModerna is looking for a Senior Specialist, Quality Control Bioassay for their Marlborough, MA facility. This role entails supporting cGMP-compliant Bioassay methods, including transfer, qualification, validation, and release testing of raw materials, plasmids, cell stocks, drug substances, and finished products for mRNA therapies manufactured at Moderna. Additionally, the specialist will take part in non-testing projects and tasks as required.Here's What You'll DoConduct molecular and protein analytics testing, utilizing various methodologies as necessary.Facilitate testing of in-process samples, drug substances, and products to produce data for commercial products.Aid in developing and maintaining lab operations in line with cGMP standards.Perform routine lab support tasks, such as preparing reagents and maintaining equipment.Write and revise SOPs, protocols, and reports.Assist with quality systems records such as deviations, change controls, CAPAs as required. Establish and maintain a safe laboratory working environment Provide support to audit teams for internal and vendor audits. Here's What You'll Bring to the Table:BS in a relevant scientific discipline with a minimum of 6-8 years (or MS in a relevant scientific discipline with 4 years) Quality Control experience in a cGMP organizationWorking knowledge of relevant and current FDA, EU, ICH guidelines and regulationsKnowledge and hands-on experience performing and troubleshooting assays such as Sequencing, electrophoresis, PCR, Residual Protein Assays, and Cell CultureExcellent troubleshooting skills and the ability to concisely communicate scientific issues.Proven ability to conduct investigations.Familiarity with electronic databases (e.g. LIMS, SAP, LMS, or equivalent software).Strong written and oral communication skills as well as organizational skills.Ability to efficiently and independently prioritize, manage and complete multiple projects and tasks in a fast-paced environment.Desired Attributes:?Ability to work collaboratively across departments.? Commitment to safety and quality.? Vision for continuous improvement and innovation.? 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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at ****** . (EEO/AAP Employer) -
