APHL Annual Report
Job Overview
Senior Scientist – Analytical Research & Development, Cell Based Sciences Department, West Point, PA. The role focuses on developing large molecule potency assays and state‑of‑the‑art analytical techniques to support vaccine process and formulation development. Responsibilities
Lead laboratory method development for vaccine candidates, including immunoassays and potency assays such as ELISA, Meso Scale Discovery, Luminex, AlphaLISA, SPR, and BLI. Design, develop, validate, and qualify analytical methods in a GLP or regulated environment, following ICH Q2 and USP guidelines. Perform antigen/antibody selection, matched pair screening, binding kinetics, multiplexing, and cell‑based assay development. Collaborate across functions and divisions to integrate analytical science into process development, formulation, and product lifecycle management. Provide detailed experimental design, data analysis, and technical reports to support regulatory filings (IND, BLA) and scientific publications. Utilize laboratory automation, design‑of‑experiments, and informatics to improve assay performance. Communicate results to stakeholders, management, and governance teams through presentations and written documentation. Education and Experience
Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or related field. OR M.S. with a minimum of 4 years of relevant experience in the biopharmaceutical industry. OR Bachelor’s degree with a minimum of 7 years of relevant experience in the biopharmaceutical industry. Required Skills
In‑depth knowledge of immunoassay development: antigen and antibody selection, matched pair screening, binding kinetics, and multiplexing. Direct laboratory experience with sandwich‑based ELISA, multiplexed ELISA, and antibody binding assays (e.g., Biacore, Octet). Strong experimental design and data analysis capabilities for analytical method development. Excellent oral, written, and presentation communication skills. Demonstrated scientific leadership through publications and conference presentations. Preferred Skills
Experience with qualification, validation, and transfer of assays to GLP or regulated laboratories. Experience representing the analytical function on cross‑functional project teams. Authoring and reviewing internal technical reports and regulatory filings. Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment. Design, execute, and direct development and qualification of release, characterization, and stability assays for clinical trial material and product development. Salary and Benefits
Salary range: $114,700.00 – $180,500.00. Eligible for annual bonus and long‑term incentives. Comprehensive benefits package includes medical, dental, vision, retirement (401(k)), paid holidays, vacation, and paid sick days. EEO Statement
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. For more information, please visit: EEOC Know Your Rights, EEOC GINA Supplement. Application
Apply through https://jobs.merck.com/us/en. Application deadline is on the posting date. For current employees, the Workday Jobs Hub is available.
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Senior Scientist – Analytical Research & Development, Cell Based Sciences Department, West Point, PA. The role focuses on developing large molecule potency assays and state‑of‑the‑art analytical techniques to support vaccine process and formulation development. Responsibilities
Lead laboratory method development for vaccine candidates, including immunoassays and potency assays such as ELISA, Meso Scale Discovery, Luminex, AlphaLISA, SPR, and BLI. Design, develop, validate, and qualify analytical methods in a GLP or regulated environment, following ICH Q2 and USP guidelines. Perform antigen/antibody selection, matched pair screening, binding kinetics, multiplexing, and cell‑based assay development. Collaborate across functions and divisions to integrate analytical science into process development, formulation, and product lifecycle management. Provide detailed experimental design, data analysis, and technical reports to support regulatory filings (IND, BLA) and scientific publications. Utilize laboratory automation, design‑of‑experiments, and informatics to improve assay performance. Communicate results to stakeholders, management, and governance teams through presentations and written documentation. Education and Experience
Ph.D. in analytical chemistry, molecular biology, cell biology, virology, or related field. OR M.S. with a minimum of 4 years of relevant experience in the biopharmaceutical industry. OR Bachelor’s degree with a minimum of 7 years of relevant experience in the biopharmaceutical industry. Required Skills
In‑depth knowledge of immunoassay development: antigen and antibody selection, matched pair screening, binding kinetics, and multiplexing. Direct laboratory experience with sandwich‑based ELISA, multiplexed ELISA, and antibody binding assays (e.g., Biacore, Octet). Strong experimental design and data analysis capabilities for analytical method development. Excellent oral, written, and presentation communication skills. Demonstrated scientific leadership through publications and conference presentations. Preferred Skills
Experience with qualification, validation, and transfer of assays to GLP or regulated laboratories. Experience representing the analytical function on cross‑functional project teams. Authoring and reviewing internal technical reports and regulatory filings. Ability to deliver complex objectives under aggressive timelines in a rapidly changing environment. Design, execute, and direct development and qualification of release, characterization, and stability assays for clinical trial material and product development. Salary and Benefits
Salary range: $114,700.00 – $180,500.00. Eligible for annual bonus and long‑term incentives. Comprehensive benefits package includes medical, dental, vision, retirement (401(k)), paid holidays, vacation, and paid sick days. EEO Statement
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. For more information, please visit: EEOC Know Your Rights, EEOC GINA Supplement. Application
Apply through https://jobs.merck.com/us/en. Application deadline is on the posting date. For current employees, the Workday Jobs Hub is available.
#J-18808-Ljbffr