Reporting to the Director of Quality Control Chemistry, this individual will be responsible for leading part of the Quality Control Chemistry Operations team. The individual in this role will focus on managing QC Associates in support of Analytical QC activities including stability, in process and release testing under cGMP regulations. This position will be based at the Norwood Site, working third shift, 10 pm to 8 am, Sunday to Wednesday.
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 Associate and Specialist teams.
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
Heres What Youll Bring to the Table:
BS/BA and minimum 5-8 years in cGMP environment. 1-3 years in a leadership role.
In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.
In-depth experience and technical knowledge of analytical methodology. HPLC/UPLC experience is a must have, additional experiences with particle analysis, plate based assays, GC, KF, Osmolality are preferred.
Proficiency and experience with scheduling, planning or project management skills, including detailed instrument and analyst scheduling.
Strong knowledge of digital quality systems (LIMS, QMS, CDS) preferred.
Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively.
Outstanding communication skills (verbal and written).
Ability to manage multiple projects in a fast-paced environment.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
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 winter shut down
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!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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 persons 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.