Sr Specialist, Quality Control, Chemistry
Moderna is seeking a Quality Control Chemistry Sr. Specialist based at their Norwood, MA site. The individual in this role will focus on Operations testing for release and stability, troubleshooting, quality system management and may support method transfers and qualifications. Also, this individual may support special projects as assigned.
Here's What You'll Do:
- Lead authoring of quality systems records such as deviations, change controls, CAPAs
- Leads Troubleshooting of methods and equipment.
- Authors Equipment and Method SOPs, Instrument Qualification documentation, Computer system validation documents and method lifecycle documents.
- Review of Executed assay packages, in both paper and electronic formats. Includes review of chromatography data and other analytical outputs.
- Performs routine analytical chemistry testing including HPLC, UPLC, GC, Particle Analysis and Dynamic Light Scattering
- Supports execution of method acquisition, qualification, re-qualification protocols.
- Performs data entry and supports trending and analysis.
- Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
- LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms
- Perform STAT HPLC (AEX) and Plate reader based assays in support of manufacturing process testing as needed, may require shift flexibility.
- Complete and maintain cGMP documentation (electronic and Hard Copy) for work performed.
- Establish and maintain a safe laboratory working environment
Here's What You'll Bring to the Table:
- Minimum education required: Bachelor's degree in a relevant scientific discipline
- Minimum experience required: 5-8 years in a laboratory setting with focus in analytical chemistry
- Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs
- Minimum knowledge required: general laboratory operations, HPLC Instrumentation/ Software, GC Instrumentation.
- 5 years' experience reviewing assay documentation, data and related analytical outputs.
- Minimum skills required:
- Technical writing
- Proficiency with Microsoft Office Programs
- Familiarity with electronic databases (e.g. LIMS, SAP, LMS)
- Practical working knowledge of HPLC/ UPLC and related software.
- Experience operating and maintaining GC equipment.
- Strong written and oral communication skills as well as organizational skills
- Knowledge of industry standards and guidelines
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
Here's What We'll Bring to the Table:
- Daily on-site catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail pass
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- Adoption assistance and discounts to local childcare centers, as well as access to care.com
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
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.