Moderna is seeking a Associate Director, Lab Operations, Bioanalytical and Molecular Laboratory s to serve as a lead for the GcLP regulated laboratory, and a point of contact to support logistical aspect of clinical specimen testing activities across multiple clinical projects. This position reports to the Sr Director of Bioanalytical and Molecular Assay group and is a part of Modernas Clinical Biomarkers group.
Heres What Youll Do:
Develop bioanalytical operations activities, timelines, metrics, and quality standards [GLP/ICH/GCP/SOPs] across clinical studies (Phase I III) in collaboration with study team members/functions
Collaborate with QA team and other functions towards the continued evolution of the Quality Management System (QMS) and execution of risk-based management solutions
Set up biospecimen accessions for clinical studies (phase I-III) and monitoring of biospecimens
Set up biospecimen accessions for clinical studies (phase I-III) and monitoring of biospecimens. Establish robust procedures to ensure shipment and tracking of biospecimen shipment through LIMS and specimen storage
Data governance (study design and database build) using appropriate LIMS
Control that stock for reagents and equipments with vendors and on-site contractors are accurate and compliant to SOPs
Coordinate with internal and external groups to identify appropriate solutions to improve on clinical sample analysis
Lead implementation of new automated platforms and their integration into the Lab operations
Manage compliance to regulations and SOPs
Establish protocols for GcLP compliance with QA analyst
Participate in strategic implementation of new technology to promote Lab automation
Lead inventory procedures and ordering supplies (chemicals, reagents, personal protective equipment, etc.) as necessary. Provide improvement process
Scheduling laboratory and equipment time for staff
Acting as a liaison between leadership staff and key stakeholders
Ensuring that all team members have been trained to use laboratory equipment, software, and supplies safely and efficiently
Maintain clinical laboratory SOPs directory
Updating the lab safety plan and safety data sheets (SDS), as necessary
Scheduling safety training for new hires or team members entering new roles
Enforcing policies around personal protective equipment
Overseeing the cleansing and sanitizing of the lab according to EHS policies and Laboratory SOPs
Heres What Youll Bring to the Table:
PhD with 5+ years of experience, or Masters degree in Medical Technology or a related scientific discipline is strongly preferred. Previous experience in working in CAP/ CLIA, GLP regulated laboratory highly preferred
At least 5 years of management experience is preferred
Knowledge in clinical sciences and technology
Previous experience in lab management and digital automation are preferred
Ability to oversee multiple aspects of the operations
Ability to balance issues of workflow and caseload
Attention to detail, organizational ability, judgement and good communication skills
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!
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. 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at firstname.lastname@example.org. (EEO/AAP Employer)