AGM/DGM-MRNA Lead

6 days ago

Hyderabad, India Right Advisors Private Limited Full time
Designation : mRNA Lead ( DGM / GM Level )
Location: Hyderabad
Leading Pharma Company in Hyderabad
Will have 3-4 members as a team . Individual should have lead a team of mRNA and has good knowledge on entire mRNA – R&D development process flow & have successfully contributed to at least 1 or 2 commercial products
Budget : open for deserving candidates
Qualification
Bachelor’s degree (minimum requirement), M.S. / Ph.D (preferred) ) in scientific discipline with 5-10 years relevant industry experience, 5+ years (at least 2 years in mRNA for DP development) in a related field at a lead level.
Division: Vaccines R&D
Primary responsibilities include to lead Drug Product (DP) development, particularly late-stage, in the biopharmaceutical/biotechnology space, to work in BioE’s drug product development team within Technology Development.
Job responsibilities:
Create and Manage process development DP for mRNA technologies.
Serve as drug product lead on projects.
Serve as drug product technology transfer lead for scale-up and technology transfer to CMOs as required. Serve as person-in-plant, where applicable.
Design and execute detailed experiments using appropriate scale down models, QbD principles and process characterization/modeling techniques to develop and trouble shoot specific unit operations.
Interface extensively in a matrixed environment with manufacturing teams, tech services at CMOs, as well as Quality and Supply chain organizations
Identify gaps in knowledge, develop and execute experimental protocols regarding drug product process needs.
Support development of processes suitable to ensure long-term stability of bulk and vialed drug product.
Provide subject matter expertise on complex aseptic liquid and lyophilization applications.
Ensure that assigned processes are cGMP compliant and are designed to meet the various regulations.
Support Regulatory submissions.
Candidate desired skills:
Excellent presentation and written/verbal communication skills
Process and Analytical Development Expertise in Biologics
Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices
Be able to communicate technically and strategically across an array of technical and operational activities and work collaboratively to help formulate and execute long-range and mid-term strategies.
Reporting to : Head R&D

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