The primary role of the successful candidate will be to design, transfer, and develop various preclinical and clinical assays for our vaccines pipeline on robotic systems in a regulated environment. The individual will be responsible to lead assay to automation transfers, qualification/validation, technology transfer, and/or troubleshooting. Importantly, the successful candidate will have a proven track record to develop, optimize, and execute various biological and chemical assays on various automation platforms. The candidate should be current on state-of-the art technologies and champion the evaluation of new technologies and optimization of processes. Providing leadership and mentorship to junior staff, building relationships with stakeholders, and providing expert technical representation on multidisciplinary teams will be expected. The candidate should have in-depth quality and compliance knowledge that aligns with current procedures, guidance's, and regulations and have deep expertise applying these concepts while overseeing the end-to-end bioanalytical phase of testing.

Education Minimum Requirement

• BA/BS with 10 years of experience, MA/MS with 6 years of experience, or PhD with 4 years. Degrees in Engineering, Automated Sciences, Computer Science, Biology, Chemistry or equivalent with scientific expertise with laboratory equipment in the development and execution of biological and chemical assays

Responsibilities

• Design and oversee operations of robotic systems to validate, optimize, and execute new vaccine program clinical assays on various automation platforms in a regulated environment
• Inform method development, qualification/validation, troubleshooting and/or assay format selection based on risk assessment and fit-for-purpose considerations
• Serve as an internal subject matter expert on developed assays, providing technical support as needed to internal and external laboratories working to implement assays
• Ensure assays are developed and executed in compliance with applicable guidance and regulations (e.g., GxP)
• Contribute to assay protocol and qualification/validation report preparation; address QA findings and observations
• Contribute to regulatory filings pertaining to assay details as needed
• Communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams
• Adhere to basic safety procedures in a BSL2 laboratory and compliance to regulations
• Provide scientific oversight for robotic platforms assays being implemented internally and externally, including review of trending data and technical reports.

Required Experience & Skills

• Experience with laboratory automation schedulers such as Cellario, Green Button Go, or Momentum
• Familiarity with liquid handlers and other automation platforms for sample preparation and assay process
• Experience with various assays formats, including but not limited to immunology assays such as ELISA, AlphaLISA, multiplexed ligand binding assays (LBA) on the company's and/or Luminex platforms or in vitro primary immune cell functional assays such as ELISpot or multi-color flow cytometry
• Ability to lead, mentor, and inspire engineers and scientists at various levels; encourages curiosity in others and challenges the status quo to foster innovation
• Well-developed decision-making skills that thinks broadly across development programs
• Familiarity with Regulated Bioanalysis and Good Laboratory Practice (GLP) is strongly desired
• Ability to independently analyze and interpret experimental data and to present and discuss results within a multi-disciplinary team environment
• Experience in Agency inspections/audits
• Proficiency to utilize statistical software for design of experiments
• Experience with regulatory submissions

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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".

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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:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
12/22/2024
*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:R326615