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Sr. Scientist, Clinical Biomarker Lab, Immuno-Assays & Bio-Analytics

Company: Moderna Theraputics
Location: Cambridge
Posted on: November 19, 2021

Job Description:

The Role: Moderna is seeking a talented, experienced and motivated Senior Scientist to join the Clinical Immuno-Assay group to serve as a scientific expert and point of contact for the oversight of immune assay development, qualification/ validation to support programs across multiple therapeutic areas. The Senior Scientist will lead a team of Research Associate Scientists for the design and in the execution of bioanalytical 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 broad knowledge of best practices in bioanalytical assay procedures, and prior experience in running assay validation and conducting data acquisition on clinical specimen. In addition, the candidate will be responsible for the training of junior team members when and where needed to perform analytical work and maintain clinical testing continuity. The ability to effectively communicate across multi-disciplinary teams and external partners is required. The candidate will stay aware of newest technology and critical reagents in his field of expertise. The candidate should be outstanding scientists, collaborative team members, excellent communicators to support Moderna's portfolio needs. The individual will work closely with research associates to develop analytical methods and characterization tools in support of our clinical phase studies. The position will report to the Director of Immuno-Assay. Here's What You'll Do: * Independently formulates novel solutions, using multiple approaches, including ex vivo assays for the design of bioanalytical assays * Design and implement experimental work, independently and accurately analyze and present data * Lead assay development, qualification and validation of bioanalytical assays to support clinical phase studies * Demonstrates technical excellence, advances high quality scientific principles in Bioanalytical science * Establish methods and testing procedures on a variety of platforms (ELISA, MSD, Ella, Hamilton---) * Lead and conduct cell-based assay * Acquire, analyze and interpret study data * Perform quality review of clinical data and experimental reports * Executes, interprets results, and draws conclusions on analyzed data * Research scientific and technical literature to propose and implement innovative solutions applicable to the Laboratory * Assess staff strengths and development needs and assign projects accordingly * Ensure staff compliance with safety and regulatory guidelines at all times. Maintain training records * Verify appropriate biological controls in experimental design * Verify performance and training of associates conducting assigned projects. * Identify and resolve quality issues and report issues to manager * Perform quality review of study reports. * Stay up to date with latest technical and scientific literature to the scope of our clinical * Attending technical conferences and exhibits as required. Here's What You'll Bring to the Table: * Ph.D. (2+ years in immunology or related field) or MSc with more than 4-6 years' experience in conducting assay validation in bioanalytics * 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 * Strong level of understanding and expertise in design and executing bioanalytical methods * Expertise in best practices recommended by FDA, CLSI to conduct development, qualification and validation of assays (e.g. M10 Bioanalytical Method Validation) * Experience with cell culture, ex vivo assays and cell isolation from tissues * Expertise with neutralization assay, Ligand assay, Neutralizing Antibody assay, serology * Experience with neutralizing antibody techniques is preferred * Experience with MSD, Spectramax, Cytation V platforms is preferred * You have superb communication skills and are able to work as a part of team and collaborate with colleagues internally * The ability to work in a cross-functional work environment is critical; strong leadership skills and independence skills are expected. * Excellent written, presentation and interpersonal communication skills; ability to influence and collaborate in a team environment. * Possess strong computational skills, preferably experienced with Word, Excel, Power Point, GraphPad Prism * Knowledge of system software for data analysis: Softmax pro GxP, Gen 5 and basic laboratory statistics. * Effective communication skills with technical staff, peers and external stakeholders. * Understanding of current GLP or CAP/CLIA/ISO standards is preferred Here's What We'll Bring to the Table: * On-site subsidized cafeteria or catered lunches * Company-provided iPhone * Free parking, monthly subway pass or a subsidized commuter rail pass * Free annual corporate membership to Bluebikes * Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP * Flexible Spending Accounts for medical expenses and dependent care expenses * 16 weeks of 100% paid parental leave for all new parents * 16 weeks 100% paid family caregiver leave * 20 weeks 100% paid medical leave * Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter) * Adoption assistance and discounts to local childcare centers, as well as access to * 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately * A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability * Voluntary legal assistance plan * 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays) Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19. Newly hired employees must be vaccinated prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law. About Moderna: In 10 years since its inception, Moderna has transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit 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 person's 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. #LI-MC1 *

Keywords: Moderna Theraputics, Cambridge , Sr. Scientist, Clinical Biomarker Lab, Immuno-Assays & Bio-Analytics, Healthcare , Cambridge, Massachusetts

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