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 3rd shift from Sunday to Wednesday (4 x 10 hrs., 10 pm to 8 am).
Here's What You'll Do
Here's What You'll Need (Minimum Qualifications)
- 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 Bring to the Table (Preferred 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
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- 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.
- 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.