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Client Overview:
Our client is a global biopharmaceutical company looking to add a Principal Scientist (MSAT, Materials Science) to their team.
Salary/Hourly Rate:
$58/hr - $62/hr, Depending on experience
Position Overview:
The Principal Scientist (MSAT, Materials Science) will support the cell and gene therapy manufacturing network by applying a deep understanding of relationships between materials properties, process conditions, and final product quality. The Principal Scientist (MSAT, Materials Science) will have in-depth conceptual knowledge of materials science and engineering principles to materials and improved process understanding, with in-depth knowledge of one or more relevant areas applicable to cell and gene therapies.
Responsibilities of the Principal Scientist (MSAT, Materials Science):
* Represent Manufacturing Science and Technology in cross-functional teams as a materials science subject matter expert for cell culture, media, single-use systems, cytokines, and/or small/large molecule raw materials.
* The Principal Scientist (MSAT, Materials Science) will support the development of key quality attributes of critical raw materials used in the cell and gene division.
* Facilitate the use of key quality attributes of the critical raw materials for raw material control and investigations.
* The Principal Scientist (MSAT, Materials Science) will drive through partnerships within MSAT the use of data analytics for raw material analysis that includes but is not limited to statistical process control/control charts for CoA attributes, correlation between raw material attributes and process performance, etc.
* Support drafting of material qualification reports.
* Support procedures and business processes to conduct raw material technical assessments, onboarding new materials and technologies, alternate material sources, as well as supplier-initiated material change notifications.
* Collaborate with risk management and program management functions to articulate technical risks and develop/manage mitigations.
Required Experience/Skills for the Principal Scientist (MSAT, Materials Science):
* 5 - 7 years of experience in the biopharmaceutical industry .
* Deep knowledge of cell culture media formulations and manufacturing, single-use systems, and small/large molecule and Cell and Gene Therapy materials.
* Previous experience working in a highly matrixed environment.
* Extensive experience with cell and gene and biologics process development and cGMP manufacturing.
* Experience with cGMP regulations/guidance and regulatory agency inspections.
* Experience working with external manufacturing partners (CDMOs), suppliers, and service providers.
Preferred Experience/Skills for the Principal Scientist (MSAT, Materials Science):
* Experience with continuous improvement, proficiency with operational excellence are preferred.
Education Requirements:
* Master's or Ph.D. in Science/Engineering or a similar field is required.
Benefits:
* Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).