Manufacturing & Technology - Principal Scientist
About The Position
This role serves as a Principal Scientist, focusing on supporting sterile commercial manufacturing operations for liquid and lyophilized parenteral products. The position involves providing technical support for the technology transfer of specific products (Nulojix and Reblozyl), acting as a Site Subject Matter Expert for formulation, filling, and lyophilization processes, and developing project plans for technical transfer activities. The scientist will design, develop, and execute experimental, characterization, and validation protocols, and support process validation and performance activities. This role also requires coordinating cross-functional activities for successful technology transfer execution and participating as a core member of Technical Transfer and New Product Introduction (NPI) teams. Additionally, the Principal Scientist will support various manufacturing studies and prepare, review, and support technical documentation.
Requirements
- 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.
- Bilingual (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.
Nice To Haves
- Being self-motivated, curious, creative, and detail-oriented.
- Commitment to serving customers with high-quality research and products.
- Embracing a diverse work culture.
- Commitment to the environment.
Responsibilities
- Support sterile commercial manufacturing operations for liquid and lyophilized parenteral products.
- Provide technical support for the technology transfer of Nulojix and Reblozyl.
- Assist the Site Subject Matter Expert for formulation, filling, and lyophilization processes.
- Develop project plans and support execution of technical transfer activities.
- Design, develop, and execute experimental, characterization, and validation protocols.
- Support process validation and process performance activities.
- Coordinate cross-functional activities to ensure successful technology transfer execution.
- Participate as a core member of Technical Transfer and New Product Introduction (NPI) teams.
- Support manufacturing studies including: Mixing Studies, Filling Studies, Lyophilization Studies, Capping Studies, Washer & Tunnel Performance Qualification (PQ).
- Prepare, review, verify, and support technical documentation including: Technical Transfer Documents, Validation Plans, Mixing Study Reports, Excipient Holding Time Studies, Drug Product Holding Time Studies, Filling Machinability Studies, Lyophilization Studies, Capping Machinability Studies.
- Participate in project meetings and provide technical recommendations.
Benefits
- Excellent, unmatched, never-before-seen customer service of our team.
- Flexible, family-oriented culture focused on employee well-being.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
