Manager, QC Chemistry

The Role

Moderna is seeking a Manager, Chemistry to support our Quality Control team specializing in Individualized Neoantigen Therapy (INT) clinical production. This position will be based in our cGMP Manufacturing site in Norwood, MA. The individual in this role will focus on managing QC Analysts and supervisors in support of Analytical activities including stability, in process and release testing under cGMP regulations.

The successful candidate will have an extensive background in Analytical Science especially HPLC. Experience with quality control and laboratory technology is preferred.

Here’s What You’ll Do

• Manage a team of associates in support of QC testing for stability, release and in process samples.

• Coordinate training, professional development and growth of the QC Analysts and Supervisors

• Manage QC OOS/OOT investigation, deviations, change controls, CAPAs in quality management

documentation system.

• Leads troubleshooting of methods and equipment.

• Execute test methods & assays as needed to support team throughput.

• Author/review/approve SOPs, test methods, QC release documents, instrument qualification,

documentation, computer system validation documents, training documents and method lifecycle

documents as needed.

• Review of executed assay packages, in both paper and electronic formats including 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 to meet project timelines.

• Coordinate and manage stability testing in partnership with QC Stability Team.

• Develop and manage scheduling and status monitoring tools to measure testing capacity,

turnaround time and to communicate progress to the larger organization.

• Participate in and partner with the Digital team to expand and optimize the use of the LIMS

(LabVantage) system.

• Manage continuous improvement projects to reduce paperwork, increase team working efficiency,

while maintaining compliance.

• 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.

• Set clear goals, objectives, and expectations for team members and monitor execution.

• Provide guidance and direction to employees in alignment with organizational strategies and

• Inspire and motivate team members to achieve their full potential.

• Establish succession plan(s) and employee development plans to support them.

• Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous

• Identify and assign appropriate deputies to support business in times of absence.

• Support daily functions related to quality control automation.

• Establish and update department protocols and procedures related to laboratory automation or digital tools/capabilities.

• Support department digital systems, including inventory, maintenance, access reviews, etc.

• Contribute to achieving Moderna’s sustainability goals.

• Collaborate with other departments to ensure that quality control automation aligns with overall business objectives.

• Stay up to date with industry trends, new technologies, and regulatory changes.

• Responsible for the regular maintenance, calibration, and troubleshooting of all QC Chemistry equipment to ensure optimal performance.

• Work with cross functional teams to support the qualification and release of QC equipment and automation systems.

Qualifications and Skills:

• Bachelor’s level degree with 10+ years of experience in the pharmaceutical/biotech industry in a cGMP laboratory with 2- 4 years in leadership role.

• Or Master’s level degree with at least 7 years of experience in the pharmaceutical/biotech industry in a cGMP laboratory with 2 – 4 years in leadership role.

• Proficient understanding of laboratory principles, techniques, and laboratory operations.

• Experience with laboratory information management systems (LIMS) and other relevant software (Chromaleon).

• Proficiency with quality management systems such as Veeva, SAP.

• Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.

• Excellent communication