Senior Scientist, Research Science
USA - New Jersey - Rahway, United States
Job Description
Translational Molecular Biomarkers (TMB) is responsible for the development and execution of clinical biomarker assays across all therapeutic areas and all phases of clinical development within 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 drug action and patient response.
The Immunoassay group within the TMB organization is seeking a highly motivated candidate to join our team. The individual will play a critical role in the development and validation immunoassay-based assays that are deployed in support of clinical trials. The candidate for this Senior Scientist position should have strong technical expertise in immunoassays for protein quantitation and enzymatic activity assessment in biological samples. The candidate should have a strong interest in lab-based assay development, validation, and clinical sample analysis. In addition, the candidate should have interest to collaborate closely with out-sourcing partners on the scientific oversight of assays that support our pipeline.
The individual will have the following responsibilities:
Develop and validate immunoassay-based assays within TMB for all therapeutic areas and all phases of clinical development.
Assist in the transition of biomarker assays from Basic Research to Clinical use by providing technical guidance on fit-for-purpose assay validation.
Interface with scientists and physicians in early and late-stage clinical development to execute on biomarker strategies in clinical trials.
Writing memos, final reports and publications summarizing data, and writing/updating lab SOPs.
Serve as a subject matter expert in immunoassay-based assay development and validation, collaborating with project teams, biomarker leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical trials.
Position Qualifications:
Education Minimum Requirement:
BS, BA, MS, or Ph.D. in a life sciences discipline (Biochemistry, Immunology, Molecular Pathology, Cell Biology, etc.) or Chemistry
Required Experience and Skills:
A minimum of 10 (for BS or BA) or 5 (for MS) years of clinical laboratory or pharmaceutical industry experience, or a doctoral degree (Ph.D.) in a related discipline (e.g. analytical chemistry, biochemistry, etc.).
A minimum of 5 years of hands-on direct experience in immunoassay-based assay development (this experience does not need to be post-graduate)
Strong experience in the handling of biofluids (plasma, serum, CSF, etc) for clinical biomarker bioanalysis.
Strong interpersonal, verbal and written communication skills
Motivated and able to work independently.
Ability to execute within a matrixed organization and collaborate with cross-functional teams.
Preferred Experience and Skills:
Broad knowledge of the drug development process and translational medicine
Hands-on experience in clinical development/operation or managing the implementation of biomarker assays in support of drug development
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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:
$104,200.00 - $163,900.00Available 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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
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N/AJob Posting End Date:
02/27/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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Hybrid Hybrid work Hybrid work model On-site Puerto Rico residents only US and Puerto Rico residents only
Benefits/PerksAccommodation during hiring process Bonus eligibility Diverse workplace Equal opportunity Equal opportunity employer Flexible work Flexible work arrangements Hands-on experience Health Care Hybrid work Hybrid work model Inclusion Inclusive environment Inclusive workplace Insurance Paid holidays Retirement benefits Sick Days Vacation
Tasks- Assay development
- Assist in assay transition to clinical use
- Collaborate with project teams and regulatory affairs
- Communication
- Compliance
- Develop and validate immunoassay-based assays
- Execution
- Innovation
- Serve as a subject matter expert
- Sourcing
- Technical Guidance
- Validation
- Write reports and lab SOPs
Analysis Analytical Analytical Chemistry Assay Development Assessment Biochemistry Biofluids handling Biological Biology Biomarker assays Biomarkers Biomarker Strategies Cell Biology Chemistry Clinical Clinical Development Clinical operations Clinical sample analysis Clinical trials Communication Compliance Cross-functional Teams Data Development Drug Development Drug development process Education Execution Immunoassay Immunoassays Immunology Inclusion Innovation Interpersonal Lab-based assay development Laboratory Life sciences Manufacturing Medicine MS Operations Organization Pharmaceutical Pharmaceutical Industry Publications Regulatory Regulatory Affairs Research Science Scientific oversight SOPS Sourcing Teams Technical Technical Expertise Technical Guidance Therapeutic Areas Translational Medicine Validation Writing Written communication
Experience5-10 years
EducationAnalytical chemistry AS B.A. Biochemistry Biology B.S. Business Cell Biology Chemistry Degree Development Doctoral Doctoral degree Graduate Health Care Immunology Life Sciences Molecular pathology MS Ph.D. Post-graduate Regulatory affairs Related discipline Science
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9