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.

Position Overview:

The Flow Cytometry group within TMB is seeking a highly motivated and skilled individual for the Associate Principal Scientist position. This role is vital for the development, validation, oversight, and troubleshooting of flow cytometric assays that are pivotal in supporting our clinical trials. The ideal candidate will possess robust technical and scientific expertise in flow cytometry, immunology, oncology, cell biology, and molecular biology, and show a strong interest in lab-based assay work. Additionally, the candidate should have experience collaborating closely with external partners to provide scientific and technical oversight for flow cytometric assays supporting our pipeline.

Key Responsibilities:

• Lead the transition of biomarker flow cytometry assays from Preclinical Research to Clinical Development.

  • Design, develop, and optimize flow cytometric assays across all therapeutic areas and clinical development phases.

  • Provide technical guidance on fit-for-purpose assay validation and troubleshoot assay and instrument-related issues.

• Collaborate and liaise with external partners and Contract Research Organizations (CROs) to manage the development, validation, and execution of flow cytometry assays.

  • Draft and review Statements of Work (SOWs), Workplans, Development Testing Agreements (DTAs), and Data Transfer Specifications (DTSs).

• Serve as a subject matter expert in flow cytometry, working with project teams, biomarker leaders, clinical operations, regulatory affairs, and physicians to implement assays and execute biomarker strategies for clinical trials.

• Prepare memos, final reports, and publications summarizing data and update lab Standard Operating Procedures (SOPs).

Position Qualifications:

Education Minimum Requirement:

• BS, BA, MS, or Ph.D. in a life sciences discipline (e.g., Biochemistry, Immunology, Cell Biology).

Required Experience and Skills:

• Experience:13 years (BA/BS), 8 years (MS) and 3 years (PhD)

• Technical Expertise:Strong understanding of translational medicine and biomarker development with extensive knowledge and experience in flow cytometry techniques, including panel design, assay development, optimization, and validation.

• Instrument Expertise: Experience with flow cytometers (e.g., BD, Cytek) including maintenance, troubleshooting, and performance optimization.

• Data Analysis Skills:Proficient in data analysis and interpretation, using software tools such as FlowJo, OMIQ, and FCS Express, with the capability to derive actionable insights from complex datasets.

• Regulatory Knowledge: Understanding of regulatory guidelines (FDA, EMA) pertaining to biomarker development and clinical trial processes.

• Project Management:Proficient project management skills to effectively plan, coordinate, and prioritize activities to achieve project goals.

• Communication Skills:Excellent interpersonal, verbal, and written communication capabilities.

• Leadership Abilities:Highly motivated, capable of working independently, and possessing strong leadership skills.

• Collaborative Mindset:Ability to execute within a matrixed organization and collaborate across functions.

Preferred Experience and Skills:

• In-depth knowledge of the latest advancements and trends in flow cytometry and translational medicine.

• Expertise in the design and development of various flow cytometry assays, including but not limited to:

  • Immunophenotyping

  • Minimal Residual Disease (MRD)

  • Receptor Occupancy

  • High-dimensional Flow Cytometry

  • Tumor-Infiltrating Lymphocytes (TILs)

  • Phospho-signaling

  • Intracellular Cytokine Profiling

  • Cellular Proliferation

• Experience working with CROs, demonstrating skills in clear communication, protocol transfer, quality agreements, secure data transfer, and regulatory compliance.

• Proficiency in handling primary cells derived from human tissues and experience in cell isolation techniques (e.g., tissue dissociation, density gradient centrifugation, magnetic bead separation, fluorescence-activated cell sorting).

• Experience in establishing and maintaining cell cultures and performing in vitro/ex vivo differentiation and stimulation functional assays.

• Willingness to provide training and mentorship to junior staff.

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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:

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:

Flexible Work Arrangements:

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Requisition ID:R336205