Merck
Senior Director, Regulated Vaccine Assay Outsourcing
Merck, West Point, Pennsylvania, us, 19486
Senior Director, Regulated Vaccine Assay Outsourcing
The Translational Sciences & Outsourcing group in the department of Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) is seeking a Senior Director to lead the regulated vaccine assay outsourcing (OS) team. The OS function within PDMB is responsible for the oversight of contract research organization (CRO) regulated preclinical/clinical assay method development, qualification/validation, and testing in support of Our Company's vaccine programs. The Senior Director is a leadership position responsible for the strategic vision, oversight and operational excellence for vaccine bioanalytical outsourcing, ensuring alignment with corporate objectives and regulatory requirements. The Senior Director will oversee a multidisciplinary team of scientists in the development, validation, and execution of bioanalytical methods that support vaccine development programs at external lab partners, while ensuring the highest standards of quality and compliance and fostering a culture of scientific rigor, collaboration, and continuous improvement. The Senior Director's responsibilities will include establishing departmental goals, managing budgets, and overseeing resource allocation to enhance outsourcing execution and efficiency. The Senior Director will collaborate closely with cross-functional teams, including research and development, regulated bioanalytical, clinical research, regulatory affairs, and quality assurance, to provide scientific leadership and strategic and operational guidance throughout the project lifecycle. Additionally, the Senior Director will play a critical role in mentoring and developing talent within the organization, fostering a culture of professional growth, diversity, innovation, and scientific excellence. This position offers a unique opportunity to influence the development of life-saving vaccines, improving public health and driving advancements in the biopharmaceutical industry. Please Note That This Is Not A Laboratory-Based Position. Main Responsibilities Include, But Are Not Limited To: Providing scientific and operational leadership to direct reports within the regulated vaccines assay outsourcing group. Leading and managing change initiatives within the group, fostering a culture of innovation and adaptability. Defining and implementing a strategic vision for the vaccines outsourcing group that aligns with organizational goals. Strong understanding of market trends and regulatory changes that impact bioanalytical practices and drug development. Driving optimization of internal and external processes aimed at improving operating efficiencies, quality, and compliance. Identifying and integrating innovative bioanalytical techniques and technologies to enhance CRO capabilities and efficiency. Cross-functional collaboration and engagement with internal and external stakeholders, including regulatory agencies, to facilitate successful project outcomes and build strategic partnerships. Effectively engage and build internal relationships with diverse teams across the organization, including Regulated Bioanalytical, Clinical Research, Regulatory, Procurement, Biostatistics, etc. to ensure Our Company scientific and quality expectations are achieved. Leading and decision-making in consultation with senior management where necessary and through participation in governance meetings, as relates to vaccine assay strategy and team management. Managing and overseeing multiple bioanalytical projects simultaneously from initiation to completion, ensuring alignment with development timelines and regulatory requirements. Mentoring and developing future leaders within the organization, promoting professional growth and scientific excellence. Serve on the OS leadership team to collaborate with other OS leaders on maintaining a strong OS organization with a focus on ensuring scientific excellence and employee development opportunities. Contract Research Organization (CRO)/vendor relationship management, setting clear expectations and standards for CRO performance and quality to ensure compliance, data quality and integrity, and on-time completion of testing. Maintaining the highest standards of quality and compliance in all bioanalytical activities, ensuring data integrity and reliability. Establishing performance metrics and driving continuous improvement initiatives to enhance CRO laboratory outcomes. Raising performance or resource concerns to vendor and escalating within Our Company, if performance issue remains unresolved. Representing Our Company leadership in Site Visits to external lab partners, including data review and compliance assessment against Our Company and regulatory agency expectations. Establishing and monitoring vaccine outsourcing group's budget, oversee forecasting efforts aligning with Finance and best Sourcing Operation practices. Review/approval of master service and project agreements, and working closely with Research Procurement on contracting, CRO onboarding process, etc. Effectively allocate resources across projects to maximize execution and efficiency and to meet organizational goals. Preparing/reviewing documentation for regulatory agency submissions, ensuring compliance with industry standards. Review/input on study testing protocols, bioanalytical reports, test methods, assay data, etc. where needed. Expertise in Interpreting complex bioanalytical data and making informed decisions to guide project direction and outcomes. Assisting direct reports with problem-solving and decision making where necessary to resolve issues. Education Minimum Requirement: PhD in Biology, Cell Biology, Virology, Immunology, Biochemistry or related field with 7+ years of broad scientific experience in immunoassay techniques including ligand binding assays, cell-based functional and neutralization assays, and/or molecular assays, and specializing in vaccines method development and validation, or Master's degree with 10+ years of experience as above, or Bachelor's degree with 14+ years of experience as above. Required Experience and Skills: Broad experience in bioanalytical development and validation, and quality control (QC) with working knowledge of regulatory agency requirements for operating in a regulated clinical and GLP testing environment. Experience working in a regulated assay testing environment preferred. An independent scientist with extensive experience in the Drug Development process and demonstrated expertise in vaccine clinical assay development and validation, with a solid understanding of how the data are being used. Ability to lead a team of direct reports, provide coaching/mentorship, conduct employee development discussions and performance assessments. Excellent technical, communication (oral and written), interpersonal, and teamwork skills. Self-motivated with a positive attitude and proven performance record. Experience with vaccine research and assay development, including broad understanding of the following techniques: Cell-based neutralization assays Ligand binding assays PCR/RT-PCR (traditional and real-time) Experience overseeing implementation of automation and robotics in a regulated testing environment is desirable. Travel Requirements: 10 - 20% Salary Range: $169,700.00 - $267,200.00 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. Job Posting End Date: 08/28/2025
The Translational Sciences & Outsourcing group in the department of Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) is seeking a Senior Director to lead the regulated vaccine assay outsourcing (OS) team. The OS function within PDMB is responsible for the oversight of contract research organization (CRO) regulated preclinical/clinical assay method development, qualification/validation, and testing in support of Our Company's vaccine programs. The Senior Director is a leadership position responsible for the strategic vision, oversight and operational excellence for vaccine bioanalytical outsourcing, ensuring alignment with corporate objectives and regulatory requirements. The Senior Director will oversee a multidisciplinary team of scientists in the development, validation, and execution of bioanalytical methods that support vaccine development programs at external lab partners, while ensuring the highest standards of quality and compliance and fostering a culture of scientific rigor, collaboration, and continuous improvement. The Senior Director's responsibilities will include establishing departmental goals, managing budgets, and overseeing resource allocation to enhance outsourcing execution and efficiency. The Senior Director will collaborate closely with cross-functional teams, including research and development, regulated bioanalytical, clinical research, regulatory affairs, and quality assurance, to provide scientific leadership and strategic and operational guidance throughout the project lifecycle. Additionally, the Senior Director will play a critical role in mentoring and developing talent within the organization, fostering a culture of professional growth, diversity, innovation, and scientific excellence. This position offers a unique opportunity to influence the development of life-saving vaccines, improving public health and driving advancements in the biopharmaceutical industry. Please Note That This Is Not A Laboratory-Based Position. Main Responsibilities Include, But Are Not Limited To: Providing scientific and operational leadership to direct reports within the regulated vaccines assay outsourcing group. Leading and managing change initiatives within the group, fostering a culture of innovation and adaptability. Defining and implementing a strategic vision for the vaccines outsourcing group that aligns with organizational goals. Strong understanding of market trends and regulatory changes that impact bioanalytical practices and drug development. Driving optimization of internal and external processes aimed at improving operating efficiencies, quality, and compliance. Identifying and integrating innovative bioanalytical techniques and technologies to enhance CRO capabilities and efficiency. Cross-functional collaboration and engagement with internal and external stakeholders, including regulatory agencies, to facilitate successful project outcomes and build strategic partnerships. Effectively engage and build internal relationships with diverse teams across the organization, including Regulated Bioanalytical, Clinical Research, Regulatory, Procurement, Biostatistics, etc. to ensure Our Company scientific and quality expectations are achieved. Leading and decision-making in consultation with senior management where necessary and through participation in governance meetings, as relates to vaccine assay strategy and team management. Managing and overseeing multiple bioanalytical projects simultaneously from initiation to completion, ensuring alignment with development timelines and regulatory requirements. Mentoring and developing future leaders within the organization, promoting professional growth and scientific excellence. Serve on the OS leadership team to collaborate with other OS leaders on maintaining a strong OS organization with a focus on ensuring scientific excellence and employee development opportunities. Contract Research Organization (CRO)/vendor relationship management, setting clear expectations and standards for CRO performance and quality to ensure compliance, data quality and integrity, and on-time completion of testing. Maintaining the highest standards of quality and compliance in all bioanalytical activities, ensuring data integrity and reliability. Establishing performance metrics and driving continuous improvement initiatives to enhance CRO laboratory outcomes. Raising performance or resource concerns to vendor and escalating within Our Company, if performance issue remains unresolved. Representing Our Company leadership in Site Visits to external lab partners, including data review and compliance assessment against Our Company and regulatory agency expectations. Establishing and monitoring vaccine outsourcing group's budget, oversee forecasting efforts aligning with Finance and best Sourcing Operation practices. Review/approval of master service and project agreements, and working closely with Research Procurement on contracting, CRO onboarding process, etc. Effectively allocate resources across projects to maximize execution and efficiency and to meet organizational goals. Preparing/reviewing documentation for regulatory agency submissions, ensuring compliance with industry standards. Review/input on study testing protocols, bioanalytical reports, test methods, assay data, etc. where needed. Expertise in Interpreting complex bioanalytical data and making informed decisions to guide project direction and outcomes. Assisting direct reports with problem-solving and decision making where necessary to resolve issues. Education Minimum Requirement: PhD in Biology, Cell Biology, Virology, Immunology, Biochemistry or related field with 7+ years of broad scientific experience in immunoassay techniques including ligand binding assays, cell-based functional and neutralization assays, and/or molecular assays, and specializing in vaccines method development and validation, or Master's degree with 10+ years of experience as above, or Bachelor's degree with 14+ years of experience as above. Required Experience and Skills: Broad experience in bioanalytical development and validation, and quality control (QC) with working knowledge of regulatory agency requirements for operating in a regulated clinical and GLP testing environment. Experience working in a regulated assay testing environment preferred. An independent scientist with extensive experience in the Drug Development process and demonstrated expertise in vaccine clinical assay development and validation, with a solid understanding of how the data are being used. Ability to lead a team of direct reports, provide coaching/mentorship, conduct employee development discussions and performance assessments. Excellent technical, communication (oral and written), interpersonal, and teamwork skills. Self-motivated with a positive attitude and proven performance record. Experience with vaccine research and assay development, including broad understanding of the following techniques: Cell-based neutralization assays Ligand binding assays PCR/RT-PCR (traditional and real-time) Experience overseeing implementation of automation and robotics in a regulated testing environment is desirable. Travel Requirements: 10 - 20% Salary Range: $169,700.00 - $267,200.00 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. Job Posting End Date: 08/28/2025