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Manager, QC Chemistry

2 months ago

Norwood, United States BioSpace, Inc. Full time
Job Details

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.

Heres What Youll 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 Modernas 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:
  • Bachelors level degree with 10+ years of experience in the pharmaceutical/biotech industry in a cGMP laboratory with 2- 4 years in leadership role.
  • Or Masters 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, leadership, and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Strong attention to detail and problem-solving skills.
  • Ability to manage multiple projects simultaneously and meet deadlines.
  • Experience with regulatory compliance and quality control measures.
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
  • This position is site-based, requiring you to be at Modernas site full-time. This position is not eligible for remote work.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
  • Highly competitive and inclusive medical, dental and vision coverage options
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Free premium access to fitness, nutrition, and mindfulness classes
  • Exclusive preferred pricing on Peloton fitness equipment
  • Adoption and family-planning benefits
  • Dedicated care coordination support for our LGBTQ+ community
  • Generous paid time off, including:
    Vacation, sick time and holidays
    Volunteer time to participate within your community
    Discretionary year-end shutdown
    Paid sabbatical after 5 years; every 3 years thereafter
  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
  • 401k match and Financial Planning tools
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
  • Complimentary concierge service including home services research, travel booking, and entertainment requests
  • Free parking or subsidized commuter passes
  • Location-specific perks and extras


About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com . (EEO/AAP Employer)

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