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 at our Company 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 Mass Spectrometry 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 of Mass Spectrometry based assays that are deployed in support of clinical trials. The candidate for this Associate Principal Scientist position should have strong technical expertise in Liquid Chromatography and Mass Spectrometry and in the quantification of peptides and proteins from tissues, particularly formalin-fixed, paraffin-embedded (FFPE) pathology tissue specimens. The candidate should have a strong interest in lab-based assay development, validation, and 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 mass spectrometry-based assays within TMB for all therapeutic areas and all phases of clinical development.
Focus on workflows and capabilities to develop mass spectrometry assays in tissue, particularly FFPE tissue.
Assist in the transition of biomarker assays from Basic Research to Clinical 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 mass spectrometry-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:
BA/MS/PhD in a life sciences discipline (Biochemistry, Immunology, Molecular Pathology, Cell Biology, etc.) or Chemistry. BA/BS+13 years; MS+8, PhD +3.
Required Experience and Skills:
A minimum of 5 years post Ph.D. in a related discipline (e.g., analytical chemistry, biochemistry, etc.).
A minimum of 2 years of hands-on direct experience in mass spectrometry-based assay development for proteins in tissues (this experience does not need to be post-graduate)
Extensive experience and knowledge in Liquid Chromatography coupled with Mass Spectrometry for quantitative assessments of peptides and proteins.
Significant experience in the handling of biofluids (Plasma, Serum, CSF, etc) for quantitative targeted analysis of small molecules, peptides and proteins.
Extensive experience using the sample preparation methods routinely employed prior to LC/MS (e.g., solid-phase extraction, protein precipitation, immunoaffinity techniques).
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.
Expertise in preparing FFPE tissue for the quantitation of peptides and proteins by LC/MS.
Preferred Experience and Skills:
Broad knowledge of the drug development process and translational medicine
Use of high-resolution mass spectrometry for the analysis of proteins and peptides.
Hands-on experience in clinical development/operation or managing the implementation of biomarker assays in support of drug development.
Experience with low flow chromatography.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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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:
$122,800.00 - $193,300.00Available 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
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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:
Not ApplicableShift:
1st - DayValid Driving License:
YesHazardous Material(s):
n/aJob Posting End Date:
11/15/2024*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.
Requisition ID:R308805