Job Description
Job Description
Senior Scientist, DMPK - Biologics
Position Summary:
We are seeking a highly motivated and experienced Senior Scientist to join our DMPK Biologics team. The successful candidate will play a key role in the design, execution, and interpretation of pharmacokinetic and ADME (Absorption, Distribution, Metabolism, and Excretion) studies to support the discovery and development of biologic therapeutics, including monoclonal antibodies, bispecifics, antibody-drug conjugates (ADCs), and novel protein modalities.
Key Responsibilities:
- Design and oversee in vitro and in vivo DMPK studies to characterize the pharmacokinetics, biodistribution, and metabolism of biologics.
- Analyze and interpret PK/PD data to support candidate selection, dose projection, and translational modeling.
- Collaborate cross-functionally with discovery, bioanalytical, toxicology, and clinical teams to integrate DMPK data into program strategies.
- Develop and validate bioanalytical methods (e.g., ligand-binding assays, LC-MS/MS) for biologics quantification.
- Contribute to regulatory submissions (IND, BLA) by authoring relevant sections and responding to agency queries.
- Stay current with scientific and regulatory developments in biologics DMPK and apply innovative approaches to enhance program success.
- Mentor junior scientists and contribute to a collaborative and inclusive team environment.
Qualifications:
- Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Biochemistry, Immunology, or related field with 3-6 years of relevant industry experience; or M.S. with 6-10 years of experience.
- Strong understanding of biologics pharmacokinetics, including FcRn biology, target-mediated drug disposition (TMDD), and immunogenicity.
- Hands-on experience with in vitro and in vivo models for biologics DMPK.
- Proficiency in PK modeling and simulation tools (e.g., Phoenix WinNonlin, NONMEM, MATLAB, or similar).
- Excellent communication and interpersonal skills with a proven ability to work in cross-functional teams.
- Experience with regulatory submissions and interactions is a plus.
- Preferred Qualifications:
- Experience with novel biologic modalities (e.g., multispecifics, fusion proteins, gene therapies).
- Familiarity with quantitative systems pharmacology (QSP) or physiologically based pharmacokinetic (PBPK) modeling.
- Publication record in peer-reviewed journals or presentations at scientific conferences.
Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiency
Company Description
A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities:\r\n•\tConducting Post Market Activities and Post Market Surveillance\r\n•\tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience:\r\n•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r\n•\tBachelor's degree\r\n•\tComputer proficiency