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Manager, Lab Scheduling, Quality Control

Company

Moderna Therapeutics

Address , Norwood, 02062, Ma
Employment type
Salary
Expires 2023-07-26
Posted at 11 months ago
Job Description
The Role:
This highly dynamic role is responsible for oversight of multiple activities in support of Moderna’s cGMP Quality Control (QC) Laboratories maintaining a valid QC site execution schedule, at a daily and shift level, for all resources to ensure on-time, in-full delivery of results and support lot releases at Moderna’s Norwood site. The manager will coordinate and schedule all QC activities, including sample collection, testing, and analysis, to ensure that they are performed in a timely and efficient manner. The QC Scheduling Manager will work closely with the QC and other department managers to ensure that all testing and analysis are completed on time. The individual is also expected to maintain and communicate testing metrics from the QC testing groups and highlight constraints to functional management. The incumbent of this role will work in close cooperation with multiple stakeholders to ensure that the planning, testing, and reporting schedule is set against company priorities.
Here’s What You’ll Do:
Develop and implement scheduling programs and procedures for QC laboratory activities
Coordinate and schedule all QC activities, including sample collection, testing, and analysis
Develop the laboratory testing schedule to meet demand and communicate capacity constraints
Ensure that all testing and analysis are completed on time and within budget
Manage, develop, and mentor a team of schedulers and coordinators
Develop and maintain relationships with internal stakeholders and external partners
Participate in continuous improvement efforts to enhance scheduling and coordination operations
Ensure compliance with regulatory requirements, including FDA, cGMP, and USP/EP/JP
Develop and monitor QC scheduling, execution, and escalation of issues
Provide regular reports on scheduling and coordination activities to senior management
Work directly with CMC project management, supply chain, QA and manufacturing teams to capture all required commercial and clinical lot testing needs for the site
Create and maintain detailed scheduling plans to support the testing demands of each lab
Lead meetings with QC laboratory sub-teams to align and facilitate discussions on priorities, quality events and overall deliverables
Communicate KPI’s and metrics that track the effectiveness of planning and testing execution.
Serve as a point of contact for information requests on status into the QC team and respond, or route accordingly
Here’s What You’ll Bring to the Table:
Bachelor level degree in Engineering, Chemistry, Supply Chain or related fields with at least 7 years’ experience; preferably in QC Laboratories
Strong understanding of cGMP, regulatory requirements and industry standards
Excellent leadership and management skills
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
Detail-oriented and organized
Proficient in Microsoft Office and scheduling software e.g. SmartQC
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
  • Paid sabbatical after 5 years; every 3 years thereafter
  • D iscretionary year-end shutdown
  • Volunteer time to participate within your community
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
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 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. We’re 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected]. (EEO/AAP Employer)
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