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 first shift from Sunday to Wednesday (4 x 10 hrs. 6 am to 4 pm).
Here’s What You’ll 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, QE and LE 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 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
Here’s What You’ll Need (Minimum Qualifications)
Minimum education required: Bachelor’s 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
Here’s What You’ll 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.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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 (url removed).
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 (url removed). (EEO/AAP Employer)
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