SCIENTIST

Job details

Kelly Science is seeking a Scientist for a growing clients Technical Services and Manufacturing Sciences group located in Elwood, KS.

Summary :

As a Scientist within the Technical Services and Manufacturing Sciences group, you will be involved in the technology transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities of the monoclonal antibody (mAb) products and processes.

Job Duties Include :

• Provide technical support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products.
• Work with R&D, manufacturing, and quality teams in execution of technical / development studies, process improvements, validation activities and technical transfer programs.
• Provide support to the manufacturing teams regarding product and process troubleshooting and mentoring.
• Participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS / OOE events.
• Ensure issues are identified and captured in the relevant quality management system and that proper root cause analysis is performed with appropriate corrective and preventative actions assigned.
• Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.
• Provide support in resolution of technical and compliance issues.
• Prepare technical assessments and responses for site quality, internal inspection bodies, and relevant Health Authorities.
• Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, risk assessments, investigations, technical studies, protocols, and reports.
• Establish and deliver training / coaching on core processes and technologies to cross functional teams.

Qualifications :

• Masters degree or PhD in a Biopharmaceutical or scientific related field strong preferred. Minimum of a Bachelors degree in a Biopharmaceutical or scientific related field required.
• 3-5+ years of industry experience within a biotech / pharmaceutical environment.
• Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes, tech transfer, scale up, and validation of biopharmaceutical processes
• Previous experience with SAP, JMP, and / or Veeva Vault strongly preferred.

Interested? Please apply today for immediate consideration!

EX2BIO2024

9553529