Principal Scientist

Company Description

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.

We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

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.

Additional Information

All your information will be kept confidential according to EEO guidelines.