Katalyst Healthcares & Life Sciences

Responsibilities:Lead and manage the Process Validation and Verification qualification at the plastic suppliers and other commodities across IGTD portfolio.Looking to hire somebody with Manufacturing Engineering and Design expertise to review the Specification of Product and Part requ المزيد...

Job description:Responsible for managing and compiling CMC sections of marketed product variations. Partner with RA CMC Project Leads and develop module 3 content and project timelines. Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.Ma المزيد...

Responsibilities:Evaluate and improve contract manufacturers processes through research design and collaboration.Develop and optimize manufacturing processes and equipment in partnership with vendors.Onboard and manage contract manufacturers ensuring regulatory compliance.Enhance manu المزيد...

Job Description: Responsible for the labeling inspecting and packaging of final container products with manual and/or automated packaging systems. Operates equipment that packages materials or products by inserting them into containers or filling containers from spouts or chutes. May المزيد...

Job Description:This position will be responsible for project management activities around developing and implementing restricted substances management (RSM) regulatory requirements such as EU REACH US Conflict Minerals US Prop. 65 EU Restriction of Hazardous Substances (RoHS) etc.Res المزيد...

Job Description: The primary role of Manufacturing Quality function is to design implement and monitoring quality control programs. Key deliverables include but not limited to recommending changes to methods procedures and standards to improve quality of output based on analysis of da المزيد...

Responsibilities :You will provide technical expertise as an experienced R programmer to develop process methodology ensuring the department meets the needs of both internal and external clients.Responsibilities include planning and coordinating the development of integrated programm المزيد...

Responsibilities:Develop and execute comprehensive SOPs to ensure strict adherence to protocol requirements and maintain the highest standards of practice while guaranteeing full compliance with Good Clinical Practice (GCP) standards.Formulate and implement robust training programs fo المزيد...

Job Description:We are seeking an experienced Lead Clinical Data Manager to oversee and manage all aspects of clinical data management activities for multiple clinical studies. The ideal candidate will ensure the accuracy integrity and quality of clinical trial data while collaboratin المزيد...

job Description:The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products.The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clini المزيد...

Job Description:The main function of a supplier quality engineer is to research and test and develop quality standards for components. A typical quality engineer has the ability to read and interpret blueprints and evaluate component integrity and standards.We are NPD Supplier Quality المزيد...

Job Description:Join a leading biomedical software development project and provide Quality Assurance oversight throughout the Software Development Life Cycle (SDLC) ensuring compliance with regulatory standards (FDA/GMP). Youll act as a QA subject matter expert on cross-functional tea المزيد...

Job Summary:The Pharmaceutical Technician will efficiently effectively and safely clean set-up and operate machinery in the manufacturing area while adhering to applicable cGMPs SOPs FDA and DEA guidelines.Responsibilities:Follow Master Batch Records for the manufacturing of controlle المزيد...

Job Description:This role supports the Market Research (MR) Compliance and Operations Team under direction and guidance from the MR Compliance Lead. The coordinator works cross-functionally supporting Analytics activities related to Market Research and GVP Activities to ensure that in المزيد...

Roles & Responsibilities:Bs degree with 9 years experience in Supplier quality from aerospace / automobile / medical.Experience in PPAP / APQP and new product development and CAPA.Supplier audits and new supplier onboard.Knowledge of quality tools such as 7 QC tools MSA SPC and ot المزيد...

Job Description:This role is responsible for executing microbiological testing environmental monitoring and method validation in a GMP-regulated laboratory. The candidate supports quality control functions including method development troubleshooting and test execution for raw materia المزيد...

Job Description:The Equipment Validation Specialist is responsible for ensuring that all critical GMP equipment and systems used in manufacturing are validated maintained and compliant with regulatory requirements. This role supports manufacturing operations by providing documented ev المزيد...

Job Description:The Lead HR Generalist reporting to the Sr. HR Manager is responsible for delivering the end-to-end Human Resources agenda for assigned departments and functions at the site. The role involves implementing and maintaining procedures and programs for site employees in a المزيد...

Job description:The Biologics CMC Developability team is an integral part of the Biologics CMC Drug Product Development Org. The Biologics CMC Developability team is responsible for- (1) the identification of biophysical- and chemical liabilities in discovery-stage biologic drug candi المزيد...

Responsibilities:Lead the development and implementation of submission-ready SDTM datasets in accordance with regulatory requirements (e.g. FDA EMA PMDA).Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards.Perfo المزيد...