Manager, Quality Control, Chemistry

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
July 12 2019
Ref
R1743
Organization Type
Biotech
Manager, Quality Control, Chemistry

The Role:

Moderna is seeking a Quality Control Chemistry Manager based at their Norwood, MA site. The individual in this role will focus on leading QC Associates and Specialists in support of Analytical QC activities including stability, in process and release testing. Additionally, this person will manage method lifecycle projects, coordinating across teams to meet business objectives.

Here's What You'll Do:
  • Manage a team of associates and specialists in support of QC Testing and Method Qualifications.
  • Coordinate training, professional development and growth of the QC Associate and Specialist teams.
  • Manage authoring of quality systems records such as deviations, change controls, CAPAs
  • Leads Troubleshooting of methods and equipment.
  • Authors Equipment and Method SOPs, Instrument Qualification documentation, Computer system validation documents and method lifecycle documents.
  • Review of Executed assay packages, in both paper and electronic formats. Includes review of chromatography data and other analytical outputs.
  • Participate in cross functional planning to align QC resources and constraints with business objectives. Prepare, provide and manage schedules for testing.
  • Coordinate and Manage Stability testing in partnership with QC Stability Team.
  • Supports authoring of method acquisition, qualification, re-qualification protocols, manages executions and supports report authoring.
  • Provide feedback and manage method remediation, change and optimization efforts in conjunction with Analytical Development.
  • Monitor and communicate method lifecycle (acquisition, qualification, implementation) timelines using project management tools.
  • Participate in and partner with the Digital team to expand and optimize the use of the LIMS (LabVantage) system.
  • Provide guidance and support to the QC-Chemistry team for compliance issues. Support preparation, management and response to compliance audits.
  • Establish and maintain a safe laboratory working environment


Here's What You'll Bring to the Table:
  • Minimum education required: Bachelor's degree in a relevant scientific discipline
  • Minimum experience required: BA: 8-10 years, MS 5-8 years in a GMP laboratory setting focused on analytical chemistry.
  • Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs
  • Minimum 3 years' experience managing teams, including testing scheduling and lab project management.
  • Minimum knowledge required: general laboratory operations, HPLC Instrumentation/ Software, method acquisition, qualification.
  • Minimum skills required:
    • Technical writing
    • Proficiency with Microsoft Office Programs
    • Familiarity with electronic databases (e.g. LIMS, SAP, LMS)
    • Practical working knowledge of HPLC/ UPLC and related software.
  • Strong written and oral communication skills as well as organizational skills
  • Knowledge of industry standards and guidelines, experience supporting compliance audits.
  • Demonstrated ability to work effectively under established guidelines and instructions
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
  • Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.


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.

#LI-PL1

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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