Supervisor, Quality Control Microbiology - Environmental Monitoring
Reporting to the Senior Manager of Quality Control (Microbiology), the Quality Control Microbiology Supervisor - Environmental Monitoring will be responsible for leading Moderna's expanding environmental and critical utility monitoring program. The QC Microbiology Supervisor - Environmental Monitoring will play a critical role in implementing, maintaining, and improving Modern's environmental and critical utility monitoring program at Moderna's Norwood, MA manufacturing facility. This position may require off-shift hours including nights and weekend.
Here's What You'll Do:
- Effectively coordinate the execution of the environmental and critical utility monitoring program for the Norwood, MA manufacturing site.
- Actively develop direct reports by seeking opportunities for cross training within and outside quality control
- Collaborate effectively across all departments to meet key objectives
- Conduct technical assessments of deviations and investigations
- Conduct routine trend analysis of environmental monitoring data and prepare associated trend reports
- Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
- Write/revise SOPs, technical protocols and reports
- Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations
- Be proactive at keeping current with literature and latest technologies associated with contamination control principals
- Effectively communicate internal issues related to performance, processes, and procedures
- Establish and maintain a safe laboratory working environment
- Accept, complete, and report on special assignments within the agreed upon timeframe
- Act as designee for the Senior Manager of Quality Control (Microbiology) as appropriate
Here's What You'll Bring to the Table:
- BS/BA and minimum 5-8 years or MS and 2-5 years in cGMP environment with a minimum of 2 years in a leadership role
- Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
- Expertise in the use of MODA is preferred
- Experience with risk management principals and their application to the development and execution of environmental monitoring and critical utility monitoring programs
- Strong and effective people management skills
- Strong knowledge of contamination control principals
- Demonstrated knowledge of method development and qualifications
- Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively
- Outstanding communication skills (verbal and written)
- Ability to manage multiple projects in a fast-paced environment
- Ability to effectively 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.