Manufacturing & Technology - Principal Scientist
On-siteManatí, Atlántico, Colombia
Job Summary
Support sterile commercial manufacturing operations for liquid and lyophilized parenteral products and provide technical support for the technology transfer of Nulojix and Reblozyl. Design, develop, and execute experimental, characterization, and validation protocols while coordinating cross-functional activities to ensure successful technology transfer execution. Prepare, review, and verify technical documentation including validation plans and mixing study reports. Participate in project meetings, develop project plans, and assist the Site Subject Matter Expert for formulation and filling processes. This role requires a Bachelor's degree in a relevant scientific discipline and five plus years of experience in the pharmaceutical or biotechnology industry. The position is for a Principal Scientist with a focus on Manufacturing Science & Technology, Process Sciences, and Technical Transfer.
Required Qualifications
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific discipline
- Five plus (5+) years of experience in the pharmaceutical or biotechnology industry
- Shift: Administrative and according to business needs
- Billingual (Spanish & English)
- Experience supporting Manufacturing Science & Technology (MS&T), Process Sciences, Technical Services, or Technical Transfer
- Strong knowledge of sterile manufacturing processes
- Experience with liquid and/or lyophilized parenteral manufacturing
- Knowledge of process validation and technology transfer activities
- Experience writing and reviewing technical documentation
- Understanding of cGMP regulations and FDA requirements
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