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Planet Pharma
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Target PR Range: 40-50/hr
*Depending on experience
Scientist II, Biologics Drug Product Development
The Biologics Drug Product Development team develops antibody drug conjugates (ADC) 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.
Key Responsibilities Include:
• 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.
Qualifications
• 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 Leadership 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.
Scientist II, Biologics Drug Product Development
Posted: 04/25/2025
2025-04-25
2025-06-11
Employment Type:
Contract
Job Category: Scientific
Job Number: 619240
Is job remote?: No
Country: United States
Job Description
Target PR Range: 40-50/hr
*Depending on experience
Scientist II, Biologics Drug Product Development
The Biologics Drug Product Development team develops antibody drug conjugates (ADC) 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.
Key Responsibilities Include:
• 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.
Qualifications
• 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 Leadership 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.
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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