Specialist, Bioassay Jobs

The Role:

Moderna is seeking a Clinical Quality Control Bioassay Specialist based at their Norwood, MA site. The Bioassay Quality Control Specialist will support cGMP Bioassay method transfer, qualification, validation and release testing for QC raw material, plasmid, cell stocks, drug substance, and finished product testing for mRNA products produced at Moderna’s manufacturing facility. This individual will contribute to non-testing special projects and activities as needed. This position will be working a 12-h Day Shift.

Here’s What You’ll Do:

• Perform general laboratory support activities including reagent preparation, equipment maintenance, etc.
• Support revisions to SOP’s, author protocols and reports.
• Participate in authoring quality systems records such as deviations, change controls, CAPAs
• Establish and maintain a safe laboratory working environment
• Support testing for in-process samples, drug substance and drug product, including generation of testing data to support clinical studies.
• Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements.
• Provide support to audit teams for internal and vendor audits.
• Execute molecular and protein analytics testing, and other methodologies as needed.

Here’s What You’ll Bring to the Table:

• Ability to efficiently and independently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
• Proven ability to conduct investigations
• Knowledge and hands-on experience performing and troubleshooting assays such as Sequencing, electrophoresis, PCR, Residual Protein Assays, and Cell Culture
• BS in a relevant scientific discipline with a minimum of 4 years (or MS in a relevant scientific discipline with 2 years) Quality Control experience in a cGMP organization
• Strong written and oral communication skills as well as organizational skills
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
• Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
• Familiarity with electronic databases (e.g. LIMS, SAP, LMS, or equivalent software)

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Location-specific perks and extras!
• Discretionary year-end shutdown
• Vacation, sick time and holidays
• Free parking or subsidized commuter passes
• Generous paid time off, including:
• Adoption and family-planning benefits
• Free premium access to fitness, nutrition, and mindfulness classes
• Paid sabbatical after 5 years; every 3 years thereafter
• Volunteer time to participate within your community
• Exclusive preferred pricing on Peloton fitness equipment
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Dedicated care coordination support for our LGBTQ+ community
• 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
• 401k match and Financial Planning tools
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 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
• Highly competitive and inclusive medical, dental and vision coverage options

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 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected]. (EEO/AAP Employer)

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