Principal Scientist, Regulated PK & ADA Bioanalytical group

POSITION DESCRIPTION:

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Department of our company’s Research Laboratories is seeking an experienced scientist to join our Regulated PK & ADA Bioanalytical group located in West Point, PA.
The position requires demonstrated expertise in the field of the bioanalysis of biotherapeutics via liquid chromatography/mass spectrometric (LC-MS) and ligand binding methods to support the PK of clinical and non-clinical studies.
In this position, you will be responsible for developing bioanalytical strategies to support the projects throughout the development phase including development of bioanalytical methods for measuring biotherapeutics, such as monoclonal antibodies, fusion proteins, and antibody-drug conjugates, in addition to small molecules and peptides.
Responsibilities also include authoring and contributing to regulatory filing documents.

EDUCATION REQUIREMENTS:

• Ph.D. in Biology, Immunology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with a minimum of 8 years of relevant industry experience or
• M.S. in chemistry/biochemistry/biology with a minimum of 10 years of relevant industry experience, or
• B.S. in chemistry/biochemistry/biology with a minimum of 15 years of relevant industry experience in a drug discovery and development setting.

REQUIRED EXPERIENCE AND SKILLS:

• Expertise in developing and managing the development and utilization of LC-MS and ligand binding assays in support of regulated (GLP and clinical) pharmacokinetic and immunogenicity studies for drug development candidates.
• Prior experience with scientific supervision of staff
• In-depth understanding of the drug development process
• Expert knowledge of the principles of regulated bioanalysis and Good Laboratory Practice (GLP)
• Excellent verbal and written communication skills
• 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.
• Knowledge of regulatory guidelines pertaining to regulated bioanalytical assays (PK and immunogenicity) is expected.
• Proven record of scientific publications and presentations at scientific meetings

PREFERRED EXPERIENCE AND SKILLS:

• Experience with antibody drug conjugate (ADC) bioanalysis is advantageous.
• A thorough knowledge of regulated bioanalysis.
• Prior work with quantitative LC/MS-based bioanalysis of therapeutic peptides, small molecules, and proteins is highly desirable.
• Experience in authoring the Integrated Summary of Immunogenicity
• Experience with immunogenicity, ADA and nAb assay development.
  This position will be located at WP PA sites and is an on-site position.

TRAVEL REQUIREMENTS:

10%

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Conduct bioanalytical work to a high degree of quality and rigor, ensuring compliance with regulatory guidelines and SOPs
• Expert review of bioanalytical data and reports
• Provide guidance and develop regulated bioanalytical methods for the quantitation of biotherapeutic drug candidates using LC-MS and ligand binding assay-based platforms in addition to emerging technologies.
• Represent the group on cross-functional project teams by serving as the bioanalytical subject matter expert (SME)
• Communicate and present bioanalytical data to stakeholders and internal scientific forums.
• Author bioanalytical reports and the bioanalytical components of regulatory submissions and drafting responses to regulatory questions

EMPLOYEES WORKING IN ROLES THAT THE COMPANY DETERMINES REQUIRE ROUTINE COLLABORATION WITH EXTERNAL STAKEHOLDERS, SUCH AS CUSTOMER-FACING COMMERCIAL, OR RESEARCH-BASED ROLES, WILL BE EXPECTED TO COMPLY NOT ONLY WITH COMPANY POLICY BUT ALSO WITH POLICIES ESTABLISHED BY SUCH EXTERNAL STAKEHOLDERS (FOR EXAMPLE, A REQUIREMENT TO BE VACCINATED AGAINST COVID-19 IN ORDER TO ACCESS A FACILITY OR MEET WITH STAKEHOLDERS). PLEASE UNDERSTAND THAT, AS PERMITTED BY APPLICABLE LAW, IF YOU HAVE NOT BEEN VACCINATED AGAINST COVID-19 AND AN ESSENTIAL FUNCTION OF YOUR JOB IS TO CALL ON EXTERNAL STAKEHOLDERS WHO REQUIRE VACCINATION TO ENTER THEIR PREMISES OR ENGAGE IN FACE-TO-FACE MEETINGS, THEN YOUR EMPLOYMENT MAY POSE AN UNDUE BURDEN TO BUSINESS OPERATIONS, IN WHICH CASE YOU MAY NOT BE OFFERED EMPLOYMENT, OR YOUR EMPLOYMENT COULD BE TERMINATED. PLEASE ALSO NOTE THAT, WHERE PERMITTED BY APPLICABLE LAW, THE COMPANY RESERVES THE RIGHT TO REQUIRE COVID-19 VACCINATIONS FOR POSITIONS, SUCH AS IN GLOBAL EMPLOYEE HEALTH, WHERE THE COMPANY DETERMINES IN ITS DISCRETION THAT THE NATURE OF THE ROLE PRESENTS AN INCREASED RISK OF DISEASE TRANSMISSION.

Current Employees apply HERE
Current Contingent Workers apply HERE