We are seeking a highly talented, motivated Bioanalytical Senior Scientist - Large Molecule within Specialty Biologics in our West Chester, PA location. We are looking for an experienced Scientist with a strong background in large molecule PK method development, validation and implementation. This role is critical in the development of biologics from early to late stages, including regulatory submission.
Provide technical expertise for evaluation and selection of PK methodology approach/format,
Contribute to the in-house method development, validation, troubleshooting,
Oversee sample testing, conduct data analysis and present data internally,
Ensure compliance and data integrity throughout the studies,
Evaluate, select CROs for study not supported in-house, oversee the work performed at the CROs,
Author, review validation plans, validation reports and bioanalytical reports,
Provide logistic support in collaboration with sample management group and CROs for clinical study (examples but not limited to sample collection/processing procedure, shipping instructions, sample reconciliation, etc…),
Lead a team of Scientists and Research Associates,
Participate in new instrument/platform evaluation.
The candidate will have proven scientific background with a
MS degree in Biochemistry, Cell Biology, Pharmacology or related field with a minimum of 10 years of relevant experience or Ph.D. with a minimum of 5 years of pharmaceutical, biotechnology or CRO bioanalytical experience.
Extensive knowledge and hands-on in ligand binding assay method development and its application to PK as evidenced by laboratory skills and/or a good publication record is required.
Familiarity with automation system, Watson LIMS system, and new ligand binding assay platforms is a plus.
Experience in clinical drug development is beneficial.
Strong managerial skills, ability to work collaboratively, ability to manage multiple projects
Good oral and written communication skills.
Research & Development