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**Senior Scientist**, a key member of Drug Product Manufacturing Science & Technology (DP MST) group, this individual will be responsible for providing sound technical and scientific support of the commercial biological drug products for manufacturing, continuous process improvement and life-cycle management. The position will serve as a drug product representative in cross function teams to provide strong technical and scientific support to help achieve project goals. This position provides leadership in handling GMP manufacturing quality systems, addressing drug product process gaps to improve product manufacturing process, and supporting regulatory submissions and inspection. In addition, the position will also be responsible for driving process capability through enhanced product and process understanding, continuous improvement, tech transfer, process validation throughout the lifecycle of commercial manufacturing processes.
The position will work closely with multiple functional groups within MST, Validation, Quality, Regulatory, and external contract organizations, and participate/lead tech transfer teams. Must be a self-motivated, be able to work with limited supervision in a highly dynamic matrix environment and effectively manage multiple tasks. Proactively identify potential issues and develop creative solutions to technical problems in order to keep projects on schedule.
* Lead and execute drug product related activities to achieve the project goals
* Perform data analysis for continuous process improvements and life cycle initiatives, aimed at improving drug product manufacturing process robustness and consistency.
* Provide technical expertise and leadership in proactively identifying and addressing drug product development gaps to improve manufacturing process through life-cycle management.
* Provide technical support for deviations, change controls, CAPA and GMP investigations for the biologics commercial drug products
* Provide technical support for regulatory submissions, responses and inspections
* Serve as a drug product representative to provide sound technical and scientific leadership and support within cross functional project teams including CMC, quality investigation and process improvement.
* Provide support for departmental operations to improve the existing system(s) and processes, and evaluation of new technology and contract partner(s).
**Education & Experience Requirements:**
* MS in Pharmaceutical Chemistry, Chemistry, Chemical Engineering or related disciplines. PhD is preferred
* Minimum of 8 years of experience for MS, 5 years for PhD in biologics formulation/process development and manufacturing is required;
* Proven record of technical capabilities;
* Proven ability to work in a fast paced environment with demonstrated capacity of handling multiple task with appropriate prioritization
* Preferred experience in statistical analysis and risk assessment
* Sound understanding of GMP quality system and good GMP practice
**Key Skills, Abilities, and Competencies:**
* Good knowledge and experience to apply Quality by Design principles and statistical analysis tools to evaluate drug product process and manufacturing process.
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