Scientist II, Biologics Drug Product Development - Katalyst CRO : Job Details

Scientist II, Biologics Drug Product Development

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Scientist II, Biologics Drug Product Development

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Job DescriptionThe Biologics Drug Product Development team develops antibody drug conjugates (Client) and other biologics by state-of-the-art formulation and analytical technologies. We create valuable intellectual property through new formulation compositions, cost effective manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.

Job DescriptionThe Biologics Drug Product Development team develops antibody drug conjugates (Client) and other biologics by state-of-the-art formulation and analytical technologies. We create valuable intellectual property through new formulation compositions, cost effective manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content.We are looking for a highly motivated person to support Developability and Formulation Development. The candidate will support early-stage assessment of candidates coming out of the Discovery pipeline, as well as the design and development of stable and robust drug product formulation for biologics used in clinical trials. In this role, the candidate will be part of a global team and will work closely with scientists from multiple functional areas, including Discovery, Analytical, and Process R&D.Responsibilities

• Support the biologics characterization and stability assessment activities of the assigned biologics, including candidate screening and selection for clinical studies and commercialization of monoclonal antibodies, antibody drug conjugates, bispecifics, and fusion proteins.
• Execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), and screen excipients (buffers, stabilizers, surfactants, etc.) to develop robust formulations for frozen, refrigerated liquid, and lyophilized dosage forms.
• Prepare concise and sound scientific presentations of experimental results to the management and assist in authoring detailed scientific technical reports.
• Stay current with the scientific literature and support new scientific initiatives.

Requirements:

• BS or MS in a scientific field and typically 4 (BS) or 2 (MS) years of relevant experience.
• Extensive hands on expertise using analytical methods for chemical and structural characterization of biologics e.g. HPLC, UPLC, capillary electrophoresis, particle analysis, and other biophysical techniques (UV-vis, DLS, DSC, etc.) for protein characterization is a requirement.
• Scientific understanding of the structure & function of monoclonal antibodies, antibody constructs/conjugates, bispecifics, and fusion proteins and their modes of degradation/stabilization.
• Strong laboratory skills focused on formulation development for monoclonal antibodies and antibody constructs/conjugates (standard excipient selection, functional excipients, high throughput assays).
• Solid understanding of the various unit operations of aseptic manufacturing such as bulk freeze thaw, compounding/mixing, filtration, filling, and lyophilization for liquid and lyophilized NBEs.

Key Competencies:

• Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
• Excellent oral communication skills in a scientific setting, as well as sound technical writing and documentation competencies are required.
• The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionResearch, Analyst, and Information Technology

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