In this role, you will be responsible for
conducts and monitors clinical trials, coordinating all contacts with the sites (solving problems, analyzing data periodically), as well as building and maintaining relationships.
In this role, the selected candidate will manage the transfer and scale-up of new custom BPCs and APIs from the customer and process development; support Biochemist IIs in the scale-up of existing manufacturing processes.
In this role, the selected candidate will design and execute experiments for extended characterization of new biologics (e.g., ADCs, bispecifics and fusion proteins); support development of therapeutic proteins at various stages.
The Senior Associate Production Scientist serves as shift leader for the manufacturing of custom biopharmaceutical APIs and manages the scale-up of current manufacturing processes consistent with current Good Manufacturing Practices.
In this role, the selected candidate will be responsible to maintain various databases related to tracking and trending process performance as required. Serve as primary technical point of contact for one or more programs.
In this position, you will provide a complete and accurate batch records at the conclusion of production operations consistent with quality guidelines including Non-Conformance Reports (NCR) if applicable.
In this role, you will manage studies to support global product development and stewardship programs that may involve the isolation and purification of radiolabeled trace metabolites from biological matrices in order to quantify, characterize and identify pesticide metabolites and environmental degradates.
In this position, you must have the ability to independently learn and implement bioinformatics software for DNA/protein sequence analysis, protein database mining, and analysis of nextgen sequencing data.
In this role, you will collaborate with asset development teams to advance clinical candidates. It is expected that the candidate will utilize his/her expertise across cmc disciplines to generate collaborations with drug product development, regulatory affairs.
In this role, the selected candidate will develop novel, testable hypotheses through intellectual processes involving literature review, exchange of scientific ideas by participation in internal and external scientific communities, and bioinformatic data mining.
In this position, you must have experience with 1H, 13C, 19F and 2D NMR including experimental design, sample preparation and qualitative and quatitative interpretation of data for organic and inorganic compounds/mixtures (small organics, steroids, peptides, proteins, and natural compounds).
The Biochemist III is responsible for the management of the transfer and scale-up of manufacturing processes of
biopharmaceutical Active Pharmaceutical Ingredients (APIs) regulated by the FDA from Customers, Process
Development and other production groups.
In this role, you will participate in the identification, development, and implementation of new technologies/platforms that improve the efficiency of the overall drug-discovery process for therapeutic proteins, especially as related to ADCs.