MSD
Associate Principal Scientist, Late Development Vaccines, Serology
MSD, Gwynedd Valley, Pennsylvania, United States
Overview
The PDMB Regulated Bioanalytics Department is seeking an Associate Principal Scientist for the Serology Lab team within the Late Development (AdVAnce) Vaccines bioanalytical group located at our new AdVAnce GxP research facility in West Point, PA. Initial roles will complete training and perform work primarily at our Springhouse Innovation Park facility in Lower Gwynedd Township, PA, with a transition to the AdVAnce facility when ready (expected 2026). This role will lead the development, validation, and implementation of bioanalytical methods for quantitative analysis of pharmaceuticals and biomarkers, ensuring compliance with regulatory standards and guidelines. You will define project objectives, manage timelines, and oversee the technical execution of complex bioanalytical studies while adhering to GLP and GMP. You will mentor junior scientists, prepare regulatory submissions and critical documentation, and drive continuous improvement within the bioanalytical function.
Responsibilities
Demonstrate expertise in relevant bioanalytical techniques Lead the development, qualification, validation, and troubleshooting of bioanalytical methods Utilize statistical methods and software for data analysis Summarize and interpret bioanalytical data while maintaining data integrity principles Apply analytical thinking and problem-solving to complex scientific challenges Devise innovative solutions for method optimization and validation issues Prepare regulatory documents and scientific reports with strong written and verbal communication skills Lead, mentor, and coach junior scientists within the department Collaborate effectively with cross-functional teams Ensure adherence to safety and environmental regulations Develop timelines and oversee multiple studies simultaneously with strong organizational and project management skills Stay updated with emerging technologies in the bioanalytical field Represent the department during audits and support outcomes Maintain high standards of quality and compliance with attention to detail Ensure familiarity with quality assurance practices and audits in a laboratory setting Education & Experience
Education Minimum Requirement: B.A./B.S. in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with at least 12 years, M.S. with at least 8 years, or Ph.D. with at least 4 years hands-on experience in related field. Required Experience & Skills
Proven track record of leading complex bioanalytical studies and managing cross-functional teams Strong expertise in bioanalytical techniques such as ELISA or other relevant methodologies for method development, qualification, validation, and troubleshooting Excellent written and verbal communication skills for technical and non-technical stakeholders Experience representing departments during audits and managing audit-related activities In-depth knowledge of regulatory compliance (FDA, EMA, ICH guidelines) and quality assurance practices (GLP, GxP) Experience with data management and integrity practices in a regulated laboratory setting Strong organizational and project management skills to oversee multiple studies Exceptional problem-solving abilities, strategic thinking, and adaptability Demonstrated ability to mentor and develop junior scientists Commitment to safety, environmental regulations, and a safe laboratory culture Growth mindset with a focus on continuous improvement and alignment with organizational objectives Preferred Experience & Skills
Experience with advanced automation platforms for bioanalytical assays Familiarity with Laboratory Information Management Systems (LIMS) and electronic data capture Proficiency in statistical analysis software for bioanalytical data interpretation Ability to lead initiatives for adopting new technologies and improving workflows Experience in late-stage clinical trial bioanalytics or vaccine development Strong strategic thinking skills focused on innovation and scientific excellence Experience performing computer systems validations Equality & Workplace
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 legally protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. All additional program policies and hybrid work guidelines apply as described by company policy. This description does not imply a contract of employment and may be subject to change.
#J-18808-Ljbffr
The PDMB Regulated Bioanalytics Department is seeking an Associate Principal Scientist for the Serology Lab team within the Late Development (AdVAnce) Vaccines bioanalytical group located at our new AdVAnce GxP research facility in West Point, PA. Initial roles will complete training and perform work primarily at our Springhouse Innovation Park facility in Lower Gwynedd Township, PA, with a transition to the AdVAnce facility when ready (expected 2026). This role will lead the development, validation, and implementation of bioanalytical methods for quantitative analysis of pharmaceuticals and biomarkers, ensuring compliance with regulatory standards and guidelines. You will define project objectives, manage timelines, and oversee the technical execution of complex bioanalytical studies while adhering to GLP and GMP. You will mentor junior scientists, prepare regulatory submissions and critical documentation, and drive continuous improvement within the bioanalytical function.
Responsibilities
Demonstrate expertise in relevant bioanalytical techniques Lead the development, qualification, validation, and troubleshooting of bioanalytical methods Utilize statistical methods and software for data analysis Summarize and interpret bioanalytical data while maintaining data integrity principles Apply analytical thinking and problem-solving to complex scientific challenges Devise innovative solutions for method optimization and validation issues Prepare regulatory documents and scientific reports with strong written and verbal communication skills Lead, mentor, and coach junior scientists within the department Collaborate effectively with cross-functional teams Ensure adherence to safety and environmental regulations Develop timelines and oversee multiple studies simultaneously with strong organizational and project management skills Stay updated with emerging technologies in the bioanalytical field Represent the department during audits and support outcomes Maintain high standards of quality and compliance with attention to detail Ensure familiarity with quality assurance practices and audits in a laboratory setting Education & Experience
Education Minimum Requirement: B.A./B.S. in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with at least 12 years, M.S. with at least 8 years, or Ph.D. with at least 4 years hands-on experience in related field. Required Experience & Skills
Proven track record of leading complex bioanalytical studies and managing cross-functional teams Strong expertise in bioanalytical techniques such as ELISA or other relevant methodologies for method development, qualification, validation, and troubleshooting Excellent written and verbal communication skills for technical and non-technical stakeholders Experience representing departments during audits and managing audit-related activities In-depth knowledge of regulatory compliance (FDA, EMA, ICH guidelines) and quality assurance practices (GLP, GxP) Experience with data management and integrity practices in a regulated laboratory setting Strong organizational and project management skills to oversee multiple studies Exceptional problem-solving abilities, strategic thinking, and adaptability Demonstrated ability to mentor and develop junior scientists Commitment to safety, environmental regulations, and a safe laboratory culture Growth mindset with a focus on continuous improvement and alignment with organizational objectives Preferred Experience & Skills
Experience with advanced automation platforms for bioanalytical assays Familiarity with Laboratory Information Management Systems (LIMS) and electronic data capture Proficiency in statistical analysis software for bioanalytical data interpretation Ability to lead initiatives for adopting new technologies and improving workflows Experience in late-stage clinical trial bioanalytics or vaccine development Strong strategic thinking skills focused on innovation and scientific excellence Experience performing computer systems validations Equality & Workplace
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 legally protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. All additional program policies and hybrid work guidelines apply as described by company policy. This description does not imply a contract of employment and may be subject to change.
#J-18808-Ljbffr