Senior Drug Product Development Leader
4 weeks ago
The Senior Drug Product Development Leader will be responsible for leading the development of drug products from pre-clinical through commercialization. This includes product image definition, formulation development, aseptic process development and characterization, container science, packaging development, process scale up, and technology transfer through validation. The ideal candidate will have a strong background in pharmaceutical sciences and engineering, with experience in managing development teams and serving on or leading such teams.
Key Responsibilities
- Lead matrixed Drug Product teams to advance fill/finish process development, process characterization, primary container / combination product development, packaging development, technology transfer, and regulatory authoring of our mRNA portfolio candidates in late-stage development.
- Interface closely with Clinical Operations and Early Development organizations to execute and support clinical in-use characterization studies and related documentation.
- Collaborate with key stakeholders (Clinical Operations, Quality, Compliance, Analytical, MS&T, Regulatory etc.) to optimize our business processes maximizing agility and consistency.
- Matrix management of a team of Scientists and Engineers responsible for the design and execution of detailed experiments using risk assessments, appropriate scale down models, QbD principles, and process characterization/modeling techniques to develop and understand drug product applications.
- Provide technical mentorship to junior scientists/engineers in all aspects of parenteral drug product development and aseptic processing.
Requirements
- Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline.
- Minimum of 8 years (PhD), 12 years (MS), 14 years (BS) industry experience in biopharmaceutical development.
- Experience in managing development teams and serving on or leading such teams comprising membership from various functional areas.
- Experience in parenteral Drug Product development and commercialization of a range of relevant drug product images such as pre-filled syringes, injection devices and vials.
- Knowledge and understanding of product/packaging interaction, barrier properties, stability, global pharmaceutical packaging regulations, and package testing.
- Prior management and mentorship experience; passion for people management and development.
About Moderna
Moderna is a leading biotechnology company that is pioneering the use of mRNA technology to develop novel therapeutics and vaccines. We are committed to advancing the field of mRNA technology and improving the lives of patients worldwide. Our team is passionate about innovation and collaboration, and we are seeking a talented and motivated individual to join our team as a Senior Drug Product Development Leader.
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