Sr. Associate, QC Microbiology at Moderna Therapeutics
Posted in Other 11 days ago.
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Type: Full Time
Location: Norwood, Massachusetts
Sr. Associate, QC Microbiology
Reporting to the Senior Manager of Quality Control (Microbiology), the Quality Control Microbiology Senior Associate will support microbiological method transfer, qualification and release testing for GMP QC raw materials, excipients, drug substance and finished product testing for mRNA products produced at Moderna s manufacturing facility and affiliated contract organizations. He/she will contribute to the implementation of QC Microbiology testing capabilities, related method transfers and qualification activities, investigations and assay/instrument troubleshooting. This position will have a primary focus in supporting Quality Control testing in association with Moderna s Personal Vaccine Unit (PVU). The position may require off-shift hours including nights and weekend.
HERE S WHAT YOU LL DO:
* Collaborate with development groups for method transfers and qualifications in support of expanding the GMP QC Microbiology laboratory capabilities to include: Rapid Sterility, Rapid Bioburden, Endotoxin, Culture Purity and Cell Stock Identity, Cell Density Determination, TOC and Conductivity Testing utilizing both standard and rapid methods.
* Support testing for raw materials, intermediates, drug substance and drug product, including generation of testing data to support clinical studies
* Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
* Assist with equipment qualification / validation activities, including maintenance
* Troubleshoot issues related to equipment, laboratory procedures and assay performance
* Conduct technical assessments of deviations and investigations
* Write/revise SOPs, technical protocols and reports
* Offer input and suggestions for improvement in laboratory operations and procedures
* Train and provide technical guidance to other microbiologists
HERE S WHAT YOU LL BRING TO THE TABLE:
* BS in a relevant scientific discipline with a minimum of 2-5 years (or MS in a relevant scientific discipline with 0-2 years) Quality Control experience in a cGMP organization with a focus in Microbiology
* Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
* Expertise with Vitek , MicroSEQ Rapid Identification Systems, Rapid Microbiology Systems and Isolator Technology
* Demonstrated knowledge of method development and qualifications
* Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
* Ability to efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
* Ability to collaborate effectively in a dynamic, cross-functional matrix environment
* Excellent communication skills (verbal and written)
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.
* 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.
* Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
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.