Job Description

Translational Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of clinical development at our Company's Research laboratories. TMB laboratories leverage a diverse array of technologies to develop biomarker assays to help confirm engagement of therapeutic targets and understand mechanisms of drug action and patient response.

The Genomics group within the TMB organization is seeking a highly motivated individual to join our team. This role will be predominantly wet-lab focused, designing and validating assays, including development of assays on novel platforms. The successful candidate will play a crucial role in developing and validating targeted as well as whole genome/transcriptome sequencing assays that are deployed to enable biomarker tests for use in clinical development of therapeutics. The successful candidate will also collaborate with external laboratories for validation, data generation and quality control, and serve as a technical expert and liaison to clinical biomarker leads and study teams. The candidate for this Associate Principal Scientist position should have extensive hands-on technical expertise in genomics and molecular techniques in somatic variant detection in infectious disease and/or oncology.

Key Responsibilities

• Lead the design, development, and analytical validation of internal next generation sequencing RNA and DNA based assays for all phases of clinical development.

• Assist in the transition of biomarker assays from Discovery Research to Clinical Development by providing technical guidance on fit-for-purpose assay validation.

• Deploy and collaborate closely with external vendors on the scientific oversight of genomics-based assays to support our Company's clinical trials globally, audit technical reports, troubleshoot issues with external vendor assays implemented in clinical trials.

• Provide scientific oversight of clinical sample analysis at vendors to ensure quality data delivery.

• Assist with maintenance of instruments and equipment according to manufacturer and SOP requirements

• Write and review validation and bioanalytical assay final reports, SOPSs and memos.

• Interface with scientists and physicians in early and late-stage clinical development to execute on biomarker strategies in clinical trials.

Education Minimum Requirement:

• BS/BA/MS/PhD in a life sciences discipline (Biochemistry, Immunology, Molecular Pathology, Cell Biology, etc.), Chemistry or Medical Laboratory Science

Required Experience and Skills:

• BA/BS with at least 13 years of relevant post-degree work experience, MS with at least 8 years of relevant work experience, or PhD with at least 3 years of relevant work experience

• A minimum of 5 years of direct hands-on experience in molecular/genomics -based assay development and validation (DNA/RNA sequencing, standard and digital PCR)

• Previous hands-on work experience with nucleic acid isolation

• Previous hand-on work experience performing short-read and long-read sequencing library preparation, platform operation, QC and troubleshooting in molecular infectious disease testing

• Detailed oriented with strong understanding of pathogen genetic diversity

• Strong interpersonal, organizational, verbal, and written communication skills along with ability to work independently.

• Proven ability to execute within a matrixed organization

Preferred Experience and Skills:

• Broad knowledge of drug development process and translational medicine

• Previous hands-on work in clinical biomarker development

• Prior experience in the field of cancer genomics

• Prior experience in clinical genomics or molecular diagnostics laboratory testing

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

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Travel Requirements:

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Requisition ID:R334572