Moderna, Inc.

Associate II, Quality Control

Moderna, Inc.$63K — $100K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • BS in a relevant scientific discipline with 0-2 years or MS with 1 year of quality control experience in a cGMP organization
  • Excellent troubleshooting skills and ability to communicate scientific issues clearly
  • Familiarity with electronic databases like LIMS, SAP, or equivalent software
  • Strong written and verbal communication and organizational skills
  • Ability to efficiently manage multiple projects in a fast-paced environment
  • Working knowledge of current FDA, EU, and ICH guidelines and regulations

Responsibilities

  • Execute compendial microbiological testing and additional methodologies as required
  • Perform microbiological methods such as Endotoxin, Bioburden, and Environmental Monitoring
  • Support testing for in-process samples and drug products, generating data for clinical studies
  • Assist in the development and maintenance of laboratory operational systems per cGMP standards
  • Conduct general lab support tasks including reagent preparation and equipment maintenance
  • Manage inventory of lab supplies and ensure availability
  • Establish and maintain safe laboratory practices

Benefits

  • Competitive healthcare and voluntary benefit programs
  • Holistic well-being resources, including fitness and mental health support
  • Family planning benefits for fertility, adoption, and surrogacy
  • Generous paid time off, including vacation and global recharge days
  • Savings and investments for future planning
  • Location-specific perks and extras
Full Job Description
The Role
Moderna is seeking a Candidate based at their Marlborough, MA site. The Individual will support cGMP microbiology methods for QC raw material, plasmid, drug substance, Stability, finished product testing for mRNA products produced and Environmental and critical utilities monitoring at Moderna's manufacturing facility. This individual will contribute to non-testing projects and activities as needed example document certification, monthly biosafety cabinet cleaning etc. This position will be working a 10-h Shift.

Here's What You'll Do
  • Execute compendial microbiological testing, and other methodologies as needed.
  • Perform methods such as Endotoxin, Bioburden, Environmental Monitoring, Microbial identification, Culture Purity,
  • Support testing for in-process samples, 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.
  • Perform general laboratory support activities including reagent preparation, equipment maintenance, weekly and monthly cleaning of the BSCs, Document Certification etc.
  • Stock and perform inventory of lab supplies.
  • Establish and maintain a safe laboratory working environment.


Here's What You'll Need (Basic Qualifications)
  • BS in a relevant scientific discipline with a minimum of 0 - 2 years (or MS in a relevant scientific discipline with 1 year) Quality Control experience in a cGMP organization
  • Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way.
  • Familiarity with electronic databases (e.g. LIMS, SAP, LMS, or equivalent software)
  • Strong written and oral communication skills as well as organizational skills
  • Ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment efficiently and independently.
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.


Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well-being resources are designed to support you-at work, at home, and everywhere in between.
  • Competitive healthcare, plus voluntary benefit programs to support your unique needs
  • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
  • Family planning benefits, including fertility, adoption, and surrogacy support
  • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
  • Savings and investments to help you plan for the future
  • Location-specific perks and extras

The salary range for this role is $63,200.00 - $100,900.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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