Technical Support Specialist
ModernaTX, Inc.

Norwood, Massachusetts

Posted in Science and Research


This job has expired.

Job Info


The Role:
Reporting to the Director of Quality Control, the Quality Control Technical Support Specialist will provide expert microbiological evaluation of process changes, support microbial control risk assessments, provide expertise to assess product impact, and provide investigation support. The Specialist will also support as needed the implementation of QC Microbiology testing capabilities, related method transfers and qualification activities, investigations and assay/instrument troubleshooting. The Specialist will provide on the floor evaluation of operations to provide microbial control assessments and continuous improvement opportunities. This role will also support daily microbiology laboratory operations through technical review of microbiological data, procedural revisions, and training support. This role will be 1st shift (7:00am - 5:00pm), Wednesday - Saturday.

Here's What You'll Do:

  • Collaborate with development groups for method transfers and qualifications of new microbiological methods as needed.
  • Draft technical investigative plans and execute testing plans as needed.
  • Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Support manufacturing operations providing microbial assessments on change controls, processes, and product impact evaluations.
  • Assist with equipment qualification / validation activities, including maintenance
  • Troubleshoot issues related to equipment, laboratory procedures and assay performance
  • Perform or 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 3-5 years (or MS in a relevant scientific discipline with 2-5 years) Quality Control experience in a cGMP organization with a focus in Microbiology
  • In-depth experience with performing microbial control risk assessments
  • Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
  • 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:
  • 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.

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