Data Management and LIMS Specialist

Job Description

The Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) Bioanalytics group in West Point, PA conducts regulated PK, immunogenicity and molecular assay development and validation, along with GLP and clinical sample analysis for the development of small molecules, vaccines and biotherapeutics. We are seeking a highly talented and motivated individual with experience developing data analysis solutions and implementing Laboratory Information Management Systems (LIMS) within the regulated bioanalytical laboratory setting. Key responsibilities will include the development, validation, enhancement and oversight of LIMS systems or related modules that are used to track sample chain of custody records, analyze bioanalytical data, and handle data management. The candidate will also provide operational support of bioanalytical sample and data flow processes, and the validation of computerized systems. While the primary focus of the role will involve vaccines assays and related systems, where experience is preferred, activities may involve other modalities and methods supported by the bioanalytical labs at our Company or external partners.

Responsibilities:

• Participate in the development, testing, validation, and implementation of LIMS systems or related upgrades to meet the needs of various bioanalytical single-plex and multiplex assays.

• Collaborate across a diverse group of stakeholders and partners to understand the end-to-end sample tracking, data analysis, data archival, and data submission needs for internal and external laboratories and developing appropriate strategies and solutions.

• Manage day to day LIMS activities for method qualification/validation and clinical study support including, but not limited to, user training, troubleshooting, study setup, sample reconciliation, and management of clinical data transfers in line with regulatory data standards.

• Develop analysis and statistical models for complex assay designs.

• Develop machine learning models to automate the data management process.

• Define and implement data classification methodologies (including data architecture, and taxonomies)

• Identify and implement new capabilities that support data handling or data integration into bioanalytical or downstream systems (e.g. electronic lab notebooks, LIMS, clinical databases, biospecimen management systems, etc.).

• Execute computer system validations associated with laboratory computerized systems and equipment

• Operate within a regulated bioanalytical laboratory, participating as needed in regulatory audits as a systems subject matter expert

• Develop departmental SOPs and related computer work instructions associated with bioanalytical laboratory systems

Education Minimum Requirement:

• B.S. Degree in Biology, Chemistry (or related sciences), or Information Technology with at least 4+ years of industry experience, an M.S. with ~2 years of related experience, or a Ph.D. with 0+ years of related experience.

Required Experience and Skills:

• Experience utilizing or implementing custom or commercial Laboratory Information Management Systems (LIMS) in a regulated bioanalytical laboratory.

• Experience working with scientific assays, including multiplex and/or single-plex bioanalytical assays, used for the support of vaccines or drug programs in development (e.g. immunogenicity, cell based assays, PK, PCR serotyping, etc.).

• Self-motivated learner with the ability to quickly analyze and interpret complex processes and problems and propose creative solutions

• Direct experience participating in computer system validations

• Strong collaborator, possessing both excellent verbal and written communication skills

• Capable of working independently under project timelines

• Experience in bioanalytical data management or related fields is preferred.

• Familiarity with data transfer processes and regulatory requirements in a clinical or laboratory setting.

• Strong analytical and problem-solving skills.

• Excellent communication and interpersonal skills for effective collaboration with cross-functional teams.

• Proficiency in using data management systems and tools (e.g., Watson, LabMatrix).

• Ability to manage multiple projects and prioritize tasks effectively.

• Detail-oriented with a commitment to maintaining data integrity and compliance.

Preferred Experience and Skills:

• Experience working specifically with vaccines bioanalytical assays, primarily those involved with immunogenicity or molecular based assessments

• Programming skills to facilitate automation of data movements

• Statistical analysis of lab data

• Development of machine learning algorithms

• Experience driving improvements for regulated bioanalytical data workflows either directly within a LIMS system or through other statistical applications

• Working knowledge of data standards (e.g. CDISC) and applicability to bioanalytical data

• Intermediate level of Microsoft Office Suite skills

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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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 salary range for this role is

$85,600.00 - $134,800.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Bioanalysis, Biochemistry, Cell Culture Techniques, Data Analysis, Data Visualization, Drug Metabolism, GMP Documentation, Good Laboratory Practices (GLPs), Immunoassays, Laboratory Information Management System (LIMS), Ligand Binding Assay, Liquid Chromatography-Mass Spectrometry (LC-MS), Pharmacokinetics

 Preferred Skills:

Job Posting End Date:

06/17/2025

*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.