Senior Pharmaceutical Process Engineer
23 hours ago
We are seeking a highly skilled and experienced Senior Pharmaceutical Process Engineer to join our team at Aditi Consulting. As a key member of our Process Development organization, you will be responsible for driving excellence and innovation in drug product manufacturing.
Key Responsibilities- Provide technical expertise in drug product process development, formulation, filtration, filling, and lyophilization.
- Develop and characterize drug product processes, and transfer new technologies to commercial sterile fill/finish sites.
- Provide process development expertise for commercial drug product processing, including Sterile processing, Process Characterization, Tech Transfer, and Validation.
- Lead and participate in global cross-functional teams to influence and drive change, efficiency, and foster strong relationships.
- Troubleshoot issues with drug product processing technologies and equipment, and champion the use of data-driven analyses and visualizations.
- Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory submissions.
- Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, or Biotechnology.
- 10+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
- Knowledge of end-to-end development for liquid and lyophilized drug products in various presentations.
- Experience with unit operation for parenteral manufacturing, specifically lyophilisation.
- Strong skills in applying fundamental engineering and scientific principles to design and implement protein freeze-thawing, filtration, mixing, filling, and/or lyophilisation processes.
- Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of Quality systems, Drug Product Manufacturing, and Validation.
- Drug product fill finish processing, holistic DP process knowledge.
- Technical transfer, drug product manufacturing, regulatory filings.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
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Senior Pharmaceutical Process Engineer
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