Biopharmaceutical Drug Product Development Lead
3 weeks ago
About the Job
This role involves leading Drug Product (DP) development, particularly in late-stage biopharmaceutical/biotechnology space, working within Technology Development team. As a DP lead, you will be responsible for creating and managing process development for mRNA technologies.
Key Responsibilities:
- Create and manage DP processes for mRNA technologies.
- Serve as drug product lead on projects.
- Design and execute experiments using scale down models, QbD principles, and process characterization/modeling techniques to develop and troubleshoot unit operations.
- Interface extensively with manufacturing teams, tech services at CMOs, Quality, and Supply Chain organizations.
- Identify knowledge gaps, develop experimental protocols regarding DP process needs, and support long-term stability of bulk and vailed drug product.
- Provide subject matter expertise on complex aseptic liquid and lyophilization applications, ensuring assigned processes are cGMP compliant and meet various regulations.
Candidate Desired Skills:
- Excellent presentation, written/verbal communication skills, and analytical thinking.
- Process and Analytical Development Expertise in Biologics, including understanding of cGMPs, USP, and ICH guidelines.
- Ability to communicate technically and strategically across technical and operational activities, collaborating to formulate and execute strategies.
About Right Advisors Private Limited
We offer a competitive salary range of $150,000 - $200,000 per annum, depending on experience, plus additional benefits such as health insurance, retirement plans, and professional development opportunities. This role is based in Hyderabad, India.
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