Scientist, Pharmacokinetics

Job DescriptionThe Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) is seeking a bioanalytical scientist to join our Regulated PK & ADA Bioanalytical group located in West Point, PA. Experience in the field of the bioanalysis of biotherapeutics via ligand binding methods to support the PK and immunogenicity components of regulated drug development studies is highly preferred. Knowledge of quantitative LC/MS-based bioanalysis of therapeutic peptides, small molecules, and proteins is advantageous. In this position, you will be responsible for developing bioanalytical methods for measuring biotherapeutics, such as monoclonal antibodies, proteins, and antibody-drug conjugates, and assessing their immunogenicity in support of Good Laboratory Practice (GLP) and clinical studies.Main Responsibilities include but are not limited to:

Method development, validation, and sample analysis for the quantitation of drug candidates in biological matrices and immunogenicity characterization (e.g., serum, plasma)

Delivering high-quality quantitative data in a timely manner to cross-functional collaborators for PK analysis.

Effectively documenting, tracking, and communicating scientific findings and recommendations within cross-functional teams

Contributing to establishing and maintaining bioanalytical lab operations including automation and analytical instrumentation.

Contributing to authoring of method development reports, test methods, qualification and validation reports, and study reports

Education Minimum Requirements:

B.A./B.S. in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with a minimum of 1+ years of relevant experience

Master’s Degree in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline

Required Experience and Skills:

Knowledge of the basic principles of regulated bioanalysis and Good Laboratory Practice (GLP)

Good verbal and written communication skills

Ability to follow procedures and thoroughly document experiments

Strong direct experience with ligand binding assay methodologies for quantitative and qualitative analysis of biotherapeutics

Understanding of the drug discovery and/or development process and DMPK science

Ability to work efficiently and multitask in a fast-paced environment

Fosters team-based approach to research; committed to working synergistically and harmoniously with others

Preferred Experience and Skills:

Experience with antibody-drug conjugate (ADC) bioanalysis is advantageous.

Prior work with quantitative LC/MS-based bioanalysis of therapeutic peptides, small molecules, or proteins.

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Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:NoHazardous Material(s):N/AJob Posting End Date:10/19/2024A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Job Posting End Date: 10/19/2024A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Requisition ID: R316078