Sr. Specialist, Quality Control (Bioassay)

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
June 01 2019
Ref
R1668
Discipline
Life Sciences, Biology
Organization Type
Biotech
Sr. Specialist, Quality Control (Bioassay)

The Role:

Reporting to the Sr. Manager of Quality Control (Bioassay), the Bioassay Quality Control Sr. Specialist will be responsible for supporting bioassay method transfer, qualification and GMP release testing for QC raw material, drug substance and finished product for mRNA products produced at Moderna's GMP manufacturing facility and affiliated contract organizations. This position will have a focus on Molecular Biology analytics, including Sequencing, qPCR and Primer Design. The individual will troubleshoot assay methods and support investigations for OOS and other non-conforming results. The role will contribute to the implementation of bioassay testing capabilities, related method transfers and qualification activities, investigations and assay/instrument troubleshooting with a high degree of independence. The individual will teach and train analysts on the Bioassay team in the aforementioned methodologies. You will act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance and Development.

Here's What You'll Do:
  • Act as the Molecular Biology subject matter expert for the team
  • Collaborate with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities, including Sequencing and qPCR assays as required.
  • Train junior laboratory staff on Molecular Biology methods
  • Write/revise SOPs, protocols and reports
  • Support testing for raw materials, 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.
  • Troubleshoot issues related to equipment, laboratory procedures and assay performance
  • Perform general laboratory support activities including reagent preparation, equipment maintenance, etc.
  • Establish and maintain a safe laboratory working environment
  • Conduct technical assessments of deviations and investigations
  • 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
  • Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations
  • Provide support to audit teams for internal and vendor audits


Here's What You'll Bring to the Table:
  • MS in a relevant scientific discipline with 2-5 years (or BS in a relevant scientific discipline with a minimum of 5 years) Quality Control experience in a cGMP organization with a focus in Molecular Biology and DNA Sequencing
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
  • Extensive knowledge and hands-on experience performing and troubleshooting Sanger Sequencing
  • Demonstrated knowledge of method qualifications
  • Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
  • Proven ability to conduct investigations
  • Ability to efficiently 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
  • 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
  • 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)


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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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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