Specialist, Quality Control Chemistry

The Role

Moderna is seeking a Quality Control Chemistry Specialist with strong chromatographic (LC/GC) experiences and troubleshooting skills. Individual in this roll is highly independent and self-motivated. He/She must have demonstrated solid scientific and technical breadth to support analytical test methods used in a biopharmaceutical manufacturing facility. The person in this role will assist lab management in OOS/OOT/OOE/LE investigation, troubleshooting methodologies, providing corrective actions and preventive actions (CAPAs), and SME training for the department. This role is assigned to the 2nd shift from Wednesday to Saturday (4 x 10 hrs., 2pm to 12am).

Heres What Youll Do

• Perform QC analytical chemistry testing including, but not limited to HPLC, UPLC, GC, UV, CE, Particle Count analysis, and Dynamic Light Scattering, KF, Osmolality, Digestion, etc,

• Ensure the analytical testing and laboratory documentation meet cGMP and GDP requirements.

• Perform raw material, in-process (STAT), finished product and stability sample analysis when needed.

• Support method validation/transfers and special projects as assigned

• Ensure stability testing completed within the required timeline.

• Perform troubleshooting methods and equipment

• Actively support OOS, OOT, OOE, lab investigations and be able to write investigation reports.

• Participates quality event investigations such as deviations, change controls, CAPAs, effectiveness check issue the related documents and follow through the event closure as needed.

• Performs data trending and supports data analysis as necessary.

• Serve SME, conduct trainings and provide coaching to help developing the junior chemists.

• Assist in preparation for regulatory, customer and internal quality audits

• Assist management to identify method gap, area for improvement and work on continuous improvement projects.

• Performs general laboratory support activities including reagent preparation, sample management

• Write/revise SOPs, protocols and reports if applicable

• Emphasize safety in Chemistry laboratory, identify safety risk and provide the risk mitigation actions.

• Additional duties as may be assigned from time to time

Heres What Youll Need (Minimum Qualifications)

• Minimum education required: Bachelors degree in a relevant scientific discipline, preferred in Analytical Chemistry, or Chemistry

• Minimum experience required: 5 years in a laboratory setting with focus in analytical chemistry

Heres What Youll Bring to the Table (Preferred Qualifications)

• Strong mathematical skills, including the ability to analyze scientific and test data, and solid understanding of statistical analysis

• Have in-depth knowledge of Analytical Chemistry theory (especially chromatographic separations by HPLC) and the operation of analytical laboratory equipment

• Have in-depth knowledge of analytical chemistry related to the SOPs and testing methods, especially for chromatographic separations using UPLC/HPLC/GC and the operation of general analytical laboratory equipment

• Be able to provide appropriate training of proper technical training to lab analysts.

• In-depth knowledge and expertise in method transfers/qualifications/validations

• Solid knowledge on cGMP, USP/EP/JP compendia testing requirements.

• Strong communication skills as well as organizational skills

• Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment while maintaining good quality

• Details and results oriented

• Solid technical writing and data interpretation skills.

• Outstanding ability to multi-task

• Strong sense of urgency

• Ability working under pressure while maintain high quality

• Ownership to the projects and commitment to meet the timelines

• Solid knowledge of lab safety

• Highly proficient use of Microsoft Word and Excel, Chromatographic Software

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

• This position is site-based, requiring you to be at Modernas site full-time. This position is not eligible for remote work.

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!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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. Were 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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