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Job Description

The Senior Specialist, West Point Analytical Sciences-Biochemistry position is responsible for providing quality and technical support to a team of Laboratory Managers, Data Analysts and Laboratory Technicians. This individual will be responsible for oversight of Deviation Management, development of corrective actions, and general technical support for Biochemistry assays. The position will also be responsible for ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations and our Company guidelines, policies and procedures. The individual in this role will be responsible for meeting and driving changes to ensure technical support needs are met. The Senior Specialist will be expected to lead the technical support in the area for which they are assigned by providing guidance for necessary changes and strong partnership with Laboratories, Divisional groups, and manufacturing areas.

The Senior Specialist will support key projects for Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories within their responsibility. As the direct technical support in the area, the individual is expected to fully manage all aspects of assigned projects and run the business activities, including but not limited to: decision making, stakeholder management, issue identification and resolution, understanding of capacity and demand, participates and drives the tier process, as appropriate, and uses this forum to escalate concerns and best practices. Proactively partners with Laboratory Quality Assurance personnel to ensure compliance with regulations, guidelines and procedures. Ensures that all process improvements and capital projects are timely, robust and in alignment with corporate goals.

Education Minimum Requirement:

+ Bachelor’s degree, a minimum or 7 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting. **OR**

+ Master’s degree, a minimum or 5 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting. **OR**

+ Ph.D. degree, 0-3 years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations or related industry experience in a laboratory, manufacturing, science related or regulated setting.

Required Experience:

+ Biochemistry or related Laboratory experience and knowledge of testing assays

Preferred Experience and Skills:

+ Proven experience in Deviation Management

+ Progressive and demonstrated Quality decision-making responsibility.

+ Strong written and verbal communication skills.

+ Project Management, Change Execution Management and Team Leadership experience in a Quality function.

+ Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.

+ Demonstrated self-starter with capability to develop innovative solutions to challenges.

+ Demonstrated facilitative leadership skills and able to lead teams to deliver results.

+ Proven analytical aptitude, critical thinking skills and ability to apply key concepts.

+ Speaks with courage and candor.

+ Proven ability to manage multiple projects/tasks simultaneously.

+ Experience in pharmaceutical laboratory operations or related environment.

+ Previous people management experience; ability to develop staff

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

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”.

**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:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

basic lab materials and BSL2

Required Skills:

Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Assay, Bioanalysis, Biochemical Assays, Biochemistry, Cell-Based Assays, Chemistry, Communication, Computer Technical Support, Corrective Action Management, Decision Making, Detail-Oriented, Facilitative Leadership, Forensic Chemistry, GMP Compliance, Good Manufacturing Practices (GMP), High-Performance Liquid Chromatography (HPLC), Laboratory Information Management System (LIMS), Laboratory Operations, Quality Standards, Root Cause Analysis (RCA), Stakeholder Management {+ 4 more}

Preferred Skills:

Job Posting End Date:

06/4/2025

*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.

**Requisition ID:** R350902