Supervisor, Quality Control (Bioassay)
Reporting to the Senior Manager of Quality Control (Bioassay), the Bioassay Quality Control Supervisor will be responsible for leading molecular biology testing in support of bioassay method transfer, qualification and release testing for QC cell banks, in-process samples, drug substance and finished product testing for mRNA products produced at Moderna's manufacturing facility and affiliated contract organizations. This position will troubleshoot assay methods and equipment and support investigations for OOS and other non-conforming results. The individual will contribute to the implementation of bioassay testing capabilities, related method transfer and qualification activities, investigations and assay/instrument troubleshooting with a high degree of independence. The role will act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance and Development. You'll supervise a team of ~3-5 analysts, as well as contribute to hands-on laboratory work. This position may require occasional off-shift hours including evenings and weekends.
Here's What You'll Do:
- Effectively coordinate the qualification and execution of QC Bioassay methods, focusing on molecular biology techniques such as qPCR, restriction mapping, agarose gel electrophoresis, and Sanger sequencing, but also supporting residual protein determination, ELISA, potency and mammalian cell-based assays
- Conduct technical assessments of deviations and investigations
- Collaborate effectively across all departments to meet key objectives
- 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
- 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 (Bioassay) as appropriate
- Actively develop direct reports by seeking opportunities for cross training
- Trains other laboratory staff on method execution and troubleshooting
- Provides support to audit teams for internal and vendor audits
Here's What You'll Bring to the Table:
- BA/BS in a relevant scientific discipline with a minimum of 5-8 years (or MS in a relevant scientific discipline with a minimum of 2-5 years) Quality Control experience in a cGMP organization with a focus in Molecular Biology
- Experience with sequencing, qPCR, and other molecular biology techniques
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
- Demonstrated knowledge of method transfers and qualifications
- Previous direct supervisory experience
- Strong and effective people management skills
- Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
- Proven ability to conduct investigations
- Demonstrated ability to effectively and independently 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.