Associate Director, Clinical Biomarker Lab, Flow Cytometry

The Role:

Moderna is seeking a talented, experienced, and motivated Associate Director to join the Clinical Cytometry group to serve as a scientific expert and point of contact for the oversight of cytometry assay development, validation, and clinical testing adhering to GCLP guidelines to support programs across multiple therapeutic areas.

The Associate Director will join a team of scientists for the design and execution of cytometry assay development, qualification or validation, and the running of clinical samples to return high quality data for clinical trials conducted by Moderna. The candidate will have a strong and proven background in clinical biomarker assessments by flow cytometry in a regulated environment. The candidate will have up to date knowledge and application of best practices in clinical flow cytometry, with extensive experience in assay validation and executing clinical studies. The ability to effectively communicate across multi-disciplinary teams and external partners is essential. The candidate will be an outstanding scientist, a collaborative team member with the ability to manage and mentor team members, and an excellent communicator to support Modernas portfolio needs.

Here's What Youll Do:

• Working with the Director of Clinical Cytometry, you will provide scientific leadership and guide the development and validation of complex and high parameter spectral (Cytek Aurora) flow cytometry assays

• Plan, guide, and oversee activities for assay development, troubleshooting, validation, and clinical testing and ensure objectives are met within established timelines.

• Work cross functionally, engaging with Biomarker leads to select appropriate assays to meet biomarker strategy goals, particularly as related to assay readiness for clinical deployment.

• Work with the Director to establish timelines for Analytical testing: study start up, clinical testing, study wrap up, and data transfer

• Opportunity to mentor and develop team members

• Be responsible for delivery of robust, high quality data packages, end to end

• Ensure work is conducted in compliance with GCLP guidelines

• Work with the team to establish new SOPs, refine existing SOPs and streamline documentation procedures

• Author reports: SOPs, analytical study plans, analytical study reports, etc.

• Research scientific and technical literature to propose, test, and implement innovative solutions applicable to the Laboratory

• Identify and resolve quality issues and employ mitigation strategies for future work

• Perform quality review of experimental data and study reports

• Engage into Innovation to support laboratory or data analysis automation

Heres What Youll Bring to the Table:

• Ph.D. (immunology or related field) and >6 years or MS (immunology or related field) and >10 years of experience focused on translational medicine and clinical biomarkers by Cytometry

• Proven experience with flow cytometry assay validation applicable to intended use of data

• Proven record of flow cytometry testing in GCLP, GLP, or CAP/CLIA environment

• Ability to maintain a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor, and operational excellence

• The ability to work in a cross-functional work environment with strong leadership skills and a good balance of creative and analytical skills

• In depth experience in performing complex multiparameter flow cytometry assays including high parameter immunophenotyping on whole Blood, ex vivo cell-based assays for functional profiling such as intracellular cytokine staining, dextramer staining, cell activation and proliferation, etc.

• Excellent written, presentation, and interpersonal communication skills with a proven ability to influence and collaborate in a team environment

• Experience in spectral cytometry desired

• Experience developing receptor occupancy assays for application to clinical studies

• Proven record of direct management of lab personnel

• Ability to handle multiple projects concurrently

• Experience in high parameter data analysis using software such as FCS Express and OMIQ and incorporation of results into LIMS database

• Candidate will be curious in exploring new technology, bold in proposing creative experimental designs and ideas. Will work collaboratively with multifunctional teams and will be relentless in pursuing successful outcomes

• Experience in Tissue isolation such as PBMC, or TILs, and with Bone marrow specimen in clinical laboratory environment is preferred

• The role and responsibilities for this position may require some travel within the USA to visit vendors site (less than 5% of the time). The position may require work after office hours and exceptionally during Saturday

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

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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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