Scientist – Regulated Pharmacokinetics and ADA

Job Description

The Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) is seeking a bioanalytical scientist to join our Regulated PK & ADA Bioanalytical group at our Innovation Park in Spring House, PA. We are looking for candidates with experience in bioanalysis of biotherapeutics to support the immunogenicity requirements of regulated drug development studies. Collaboration, innovation, teamwork, and accountability are highly valued within our team. The successful candidate will play a key role in method development, validation, and analysis of neutralizing antibody methods for the company's pipeline.

Main Responsibilities include but are not limited to:

• Method development and validation of neutralizing antibody assays for different therapeutics.

• Generation of quality data to support clinical studies

• Providing timely delivery of high-quality quantitative data to cross-functional collaborators for neutralizing antibody analysis.

• Document, track, and communicate scientific findings effectively within cross-functional teams.

• Assisting in establishing and managing bioanalytical lab operations, including automation and analytical instrumentation.

• Contribution to the 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 3 years of relevant experience

• Master’s Degree in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline with 1 to 3 years of experience

Required Experience and Skills:

• Demonstrated expertise developing, troubleshooting, and performing bioanalytical assays in plate-based and cell-based neutralizing antibody (NAb) assays for different therapeutics

• Experience in different bioanalytical technology platforms, such as ELISA, our company, Ensight, Biacore/SPR etc.

• Knowledge of GLP requirements and understanding of current industry trends and regulatory expectations associated with bioanalytical science.

• Good verbal and written communication skills

• Experience in good documentation practices

• Ability to follow procedures and thoroughly document experiments.

• Capable of working efficiently and multitasking in a fast-paced environment

• Emphasizes a team-based approach and is dedicated to collaborative and harmonious work with others.

Preferred Experience and Skills:

• Use of automation platforms to perform preclinical and clinical assays.

• Previous work experience in regulated industry environment and a solid understanding of current GLP standards

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet