Merck · 2 days ago
Spclst, Quality Control, Site Analytical Sciences
Lansdale, PA
Full-time
Hybrid
Mid Level
$86K/yr - $135K/yrMerck is a leading global healthcare company that is seeking a Site Analytical Sciences Specialist to support Analytical Procedure Life Cycle management. This role involves introducing new analytical methods, conducting product testing, and ensuring compliance with regulatory standards while fostering a culture of continuous improvement.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
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
Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools
The Analytical Sciences Team Lead 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
Qualification
Required
Minimum education – Bachelors Degree in Biology, Chemistry, Engineering or related field
Technical expertise to support: New method introduction (Validation /Tech Transfer)
Technical expertise to support: 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
Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools
The Analytical Sciences Team Lead 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
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
Founded in 1891
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-08
2026-01-08
2026-01-08
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