Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
The Principal Scientist, Manufacturing Science and Technology (MSAT) – Materials Science will support the Our client Cell and Gene Therapy (VCGT) manufacturing network by applying a deep understanding of relationships between materials properties, process conditions, and final product quality. The role will have a proven track record of applying 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:
- Represent the MSAT function in cross-functional teams as a materials science SME for single-use systems, cell culture media, cytokines, and/or small/large molecule raw materials.
- Support the development of key quality attributes of critical raw materials used in Our client's cell and gene division.
- Facilitate the use of key quality attributes of the critical raw materials for raw material control and investigations.
- 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 with cross functional teams.
- Supports 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.
Requirements:
- Requires 5-7 years of relevant experience in the biopharmaceutical industry or the equivalent combination of education and experience.
- Advanced degree (MS/ Ph.D./ Eng Doc) in Science/Engineering is preferred.
- Deep knowledge of cell culture media formulations and manufacturing, single-use-systems, and small/large molecule and CGT materials.
- Previous experience working in a highly matrixed environment.
- Flexibility to work on site a minimum of 3 days per week.
- Extensive experience with cell and gene and biologics process development and cGMP manufacturing.
- Experience with cGMP regulations/guidance and regulatory agency inspections.
- Experience with continuous improvement, proficiency with operational excellence preferred.
- Experience working with external manufacturing partners (CDMOs), suppliers, and service providers.