Merck
Overview
Job Description
The Site Analytical Sciences 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 and 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.
Responsibilities
New method introduction (Validation / Tech Transfer).
New technology introduction.
Assessment and implementation of changes for existing methods and equipment: parameter changes, column/reagent changes.
Method troubleshooting where cross-functional investigation is required.
Technical SME for regulatory questions, audit support, reagent changes / supply issues with justification for analytical methods and equipment.
Technical review of impact on Analytical methods and equipment as part of cross-functional team assessments of new or 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 and for non-execution related investigations.
Authoring technical documentation in support of investigations 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 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.
Organization
Reports to:
Site Analytical Sciences Lead
Key Behaviours
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.
Experience Requirements
1+ years (with BCs) 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 and ability to manage multiple priorities.
Strong project and stakeholder management skills 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 progress priorities.
Experience in problem solving, risk management, decision making and troubleshooting 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 interaction with inspectors, responding to observations, and monitoring of commitments.
Education
Minimum requirement: B.S and 1+ years of relevant work experience
Preferred: Advanced degrees
Required Skills Adaptability, Analytical Instrumentation, Analytical Method Development, Assay, Biochemical Analysis, Biochemical Assays, Biopharmaceutical Industry, Capital Projects, Cell-Based Assays, Chemistry, Dissolution Testing, Documentation, Driving Continuous Improvement, GMP Compliance, HPLC, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Leadership, Microbiological Analysis, Microbiological Test, Microbiology, Molecular Microbiology, PCR
Preferred Skills Current Employees apply HERE
Current Contingent Workers apply HERE
Equal Employment Opportunity We are an Equal Employment Opportunity Employer. We comply with applicable laws and do not discriminate on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability status, or other legally protected characteristics.
US and Local Compliance California and other U.S. State Acts may apply as applicable. For accommodation during the application or hiring process, please contact us.
Hybrid Work Model U.S. Hybrid Work Model applies; details are provided by the employer. This description may include up-to-date information about work arrangments.
Compensation and Benefits The salary range for this role is $85,600.00 - $134,800.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and sick days. More information at the employer’s compensation and benefits page.
Application You can apply for this role through the employer’s careers site. The application deadline is stated on the posting.
Legal Notices San Francisco and Los Angeles residents: we comply with local fair chance laws. We do not discriminate in our hiring practices in accordance with applicable laws.
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The Site Analytical Sciences 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 and 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.
Responsibilities
New method introduction (Validation / Tech Transfer).
New technology introduction.
Assessment and implementation of changes for existing methods and equipment: parameter changes, column/reagent changes.
Method troubleshooting where cross-functional investigation is required.
Technical SME for regulatory questions, audit support, reagent changes / supply issues with justification for analytical methods and equipment.
Technical review of impact on Analytical methods and equipment as part of cross-functional team assessments of new or 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 and for non-execution related investigations.
Authoring technical documentation in support of investigations 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 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.
Organization
Reports to:
Site Analytical Sciences Lead
Key Behaviours
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.
Experience Requirements
1+ years (with BCs) 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 and ability to manage multiple priorities.
Strong project and stakeholder management skills 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 progress priorities.
Experience in problem solving, risk management, decision making and troubleshooting 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 interaction with inspectors, responding to observations, and monitoring of commitments.
Education
Minimum requirement: B.S and 1+ years of relevant work experience
Preferred: Advanced degrees
Required Skills Adaptability, Analytical Instrumentation, Analytical Method Development, Assay, Biochemical Analysis, Biochemical Assays, Biopharmaceutical Industry, Capital Projects, Cell-Based Assays, Chemistry, Dissolution Testing, Documentation, Driving Continuous Improvement, GMP Compliance, HPLC, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Leadership, Microbiological Analysis, Microbiological Test, Microbiology, Molecular Microbiology, PCR
Preferred Skills Current Employees apply HERE
Current Contingent Workers apply HERE
Equal Employment Opportunity We are an Equal Employment Opportunity Employer. We comply with applicable laws and do not discriminate on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability status, or other legally protected characteristics.
US and Local Compliance California and other U.S. State Acts may apply as applicable. For accommodation during the application or hiring process, please contact us.
Hybrid Work Model U.S. Hybrid Work Model applies; details are provided by the employer. This description may include up-to-date information about work arrangments.
Compensation and Benefits The salary range for this role is $85,600.00 - $134,800.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and sick days. More information at the employer’s compensation and benefits page.
Application You can apply for this role through the employer’s careers site. The application deadline is stated on the posting.
Legal Notices San Francisco and Los Angeles residents: we comply with local fair chance laws. We do not discriminate in our hiring practices in accordance with applicable laws.
#J-18808-Ljbffr