What are the responsibilities and job description for the Specialist, Bioassay position at Moderna?
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:
Execute molecular and protein analytics testing, and other methodologies as needed.
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.
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
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 4 years (or MS in a relevant scientific discipline with 2 years) Quality Control experience in a cGMP organization
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
Knowledge and hands-on experience performing and troubleshooting assays such as Sequencing, electrophoresis, PCR, Residual Protein Assays, and Cell Culture
Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
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
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
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 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.
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