Moderna Therapeutics Inc.
Analyst II, Quality Control
Moderna Therapeutics Inc., Norwood, Massachusetts, us, 02062
The RoleIn this role, you will support cGMP QC testing for raw materials, drug substances, and finished products at the company's manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, supporting method transfers, qualification activities, and ensuring compliance with cGMP standards. This is an on-site position.The shift is Sunday to Wednesday 1st shift.Here’s What You’ll DoExecute QC molecular biology and Bioassay methods (e.g. qPCR, sequencing, protein expression (cell based and cell free))Assist in troubleshooting equipment and assay issues.Perform general laboratory support activities including reagent preparation, equipment maintenance, housekeeping, logbook reviews, etc.Establish and maintain a safe laboratory working environment.Write, revise, and maintain SOPs, protocols, and reports.Support training as assigned.Assist in execution of Quality records (i.e. investigations, change controls, CAPAs)Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.Additional duties may be assigned.Here’s What You’ll Need (
Basic
Qualifications)Education:
BA/BS DegreeExperience:
STEM degree with 3-5 years of experience in a cGMP laboratory setting, with hands-on experience in molecular biology and cell based assaysSpecific Certifications or Training:
NoneHere’s What You’ll Bring to the Table (Preferred Qualifications)Method development/qualification experience with molecular biology, cell-based assays, or protein analysis methods.Trained in Aseptic techniques and general laboratory instrumentation (e.g. pH meters, balances, pipettes)Ability to prepare reagents, pipette small volumes, work in a Biological Safety CabinetExperience with laboratory equipment calibration and maintenance.Ability to work effectively in a fast-paced, cross-functional matrix environment.Familiarity with relevant FDA, EU, ICH guidelines, and regulations.A desire to make an impact as part of a high-growth, transformational company that is
Bold, Relentless, Curious, and Collaborative.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 people are 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.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.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.
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Basic
Qualifications)Education:
BA/BS DegreeExperience:
STEM degree with 3-5 years of experience in a cGMP laboratory setting, with hands-on experience in molecular biology and cell based assaysSpecific Certifications or Training:
NoneHere’s What You’ll Bring to the Table (Preferred Qualifications)Method development/qualification experience with molecular biology, cell-based assays, or protein analysis methods.Trained in Aseptic techniques and general laboratory instrumentation (e.g. pH meters, balances, pipettes)Ability to prepare reagents, pipette small volumes, work in a Biological Safety CabinetExperience with laboratory equipment calibration and maintenance.Ability to work effectively in a fast-paced, cross-functional matrix environment.Familiarity with relevant FDA, EU, ICH guidelines, and regulations.A desire to make an impact as part of a high-growth, transformational company that is
Bold, Relentless, Curious, and Collaborative.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 people are 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.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.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.
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