Supervisor, Quality Control, Bioassay 1st Shift
ModernaTX, Inc.

Job Info

---

The Role:

Reporting to the Sr. Manager of Quality Control Bioassay, the Bioassay Quality Control Supervisor will be responsible for leading molecular biology testing in support of 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 and support investigations for OOS and other non-conforming results. The individual will contribute to the implementation of bioassay testing capabilities, 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 ~5-7 analysts, as well as contribute to hands-on laboratory work. This position will be 2nd shift (2:00pm - 12:00am), Wednesday-Saturday or Sunday-Wednesday.

Here's What You'll Do:

• Effectively coordinate the 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:

• On-site subsidized cafeteria or catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Free annual corporate membership to Bluebikes
• 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
• Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
• 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 (includes 2 floating holidays)

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 10 years since its inception,Modernahas transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.Modernamaintains 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 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 auto-immune diseases.Modernahas been named a top biopharmaceutical employer bySciencefor 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.

#LI-ES1
-

This job has expired.