Description

Job Description

Purpose of Role:

The Site Analytical Sciences senior Specialist role is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations, biochemistry, and microbiology.

Activities Within Role:

Technical expertise to support:

• New method introduction (Validation /Tech Transfer).
• New technology introduction.

Assessment and implementation of changes for existing methods and equipment:

• Change in technical element of method e.g. Parameter change
• Change in equipment element of method e.g., column/reagent change.
• Method troubleshooting where cross-functional investigation is required.
• Technical SME for regulatory questions, audit support, reagent changes / supply issues to provided justification / rationale for analytical methods and equipment.
• Technical review of impact on Analytical methods and equipment as part of cross-functional team assessment of new/revised Global Test method / Compendia changes or updates.
• Management of PQ aspect of equipment qualification for all Quality Equipment, support IQ and OQ as required as part of capital projects.
• Analytical equipment troubleshooting.
• Initial training of end users in QC and Manufacturing and training of site analytical sciences personnel on lab systems, processes and methods where agreed.
• Investigation lead/support for lab investigations.
• Investigation lead for non-execution related investigations.
• Authoring technical documentation in support of investigation and regulatory responses.
• Analytical impact assessors on all QC Lab OPS change controls.
• Technical Impact Assessment of proposed and finalized compendial changes.
• Development and ownership of change control for new analytical methods.
• Routine Assay Monitoring and lifecycle management of analytical methods.
• Supporting digital method development.

Continuous Improvements:

• Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools

Coaching and Training:

• The Senior Specialist will provide support, guidance, and expertise to ensure the success of the Analytical Sciences group; will model the company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organization.

Reports to:

• Site Analytical Sciences Lead

Behaviors, Job Experience and Qualifications

Key Behaviors:

• Win as one team.
• Focus on what matters.
• Act with urgency.
• Experiment, learn and adapt.
• Embrace diversity and inclusion.
• Speak Up and be open-minded

Educational and Experience Requirements:

• Minimum of a Bachelors degree
• Preferred 3+ years with advanced degree working on analytical method introduction and qualification within the biopharmaceutical and/or pharmaceutical industry.
• Experience with analytical methods (HPLC, cGE, ELISA, Bioassays, PCR, compendial methods, Microbial methods, cell-based assays)
• Flexible, self-motivated & ability to manage multiple priorities.
• Strong project management and stakeholder management skills required with demonstrated ability to influence across internal and external stakeholders.
• Proven ability to work as part of an interdependent team but also on own initiative to ensure progression of priorities.
• Experience in problem solving (facilitation & application of tools), risk management, decision making & trouble shooting skills.
• Excellent communication skills - verbal, written, presentations.
• Ability to coach and support development of AS&T Scientists and QC technicians within AS&T and QC teams.
• Provide leadership and expertise for preparation of regulatory submissions, inspection readiness, and support health authority inspections - including but not limited to interaction with inspectors, responding to observations and monitoring of commitments.

Required Skills:
Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Assay, Biochemical Analysis, Biopharmaceutical Industry, Biopharmaceuticals, Capital Projects, Cell-Based Assays, Chemistry, Communication, Decision Making, Detail-Oriented, Driving Continuous Improvement, Forensic Chemistry, Good Manufacturing Practices (GMP), High-Performance Liquid Chromatography (HPLC), Laboratory Information Management System (LIMS), Laboratory Operations, Microbiological Analysis, Microbiology, Molecular Microbiology, Polymerase Chain Reaction (PCR), Quality Standards {+ 5 more}

Preferred 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:

EEOC Know Your Rights

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

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
$104,200.00 - $163,900.00

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

Job Posting End Date:
11/27/2025
*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:R370192