DGM/ GM

2 days ago

Hyderabad, India Right Advisors Private Limited Full time

Position Title / Role

Deputy General Manager/ General Manager - MRNA Lead


Qualification & Experience

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.


Unit / Location

Hyderabad


Division

Vaccines R&D


Main purpose of the Job:

Primary responsibilities include to lead Drug Product (DP) development, particularly late-stage, in the biopharmaceutical/biotechnology space, to work in 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:

  1. · Excellent presentation and written/verbal communication skills
  2. · Process and Analytical Development Expertise in Biologics
  3. · Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices
  4. · 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.

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