Katalyst Healthcares & Life Sciences

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...

Responsibilities:Support the plant manufacturing effort with ability to identify problems and specific focus will be in areas of improving quality waste and equipment efficiencies.Application of Transfer functions during troubleshooting and production support (i.e. Statistical Toleran المزيد...

Responsibilities:Maintains all qualified and validated equipment and systems in compliance with policies guidelines and procedures.Develops protocols and associated reports while adhering to a change management process.Supports the execution of equipment qualifications and validation المزيد...

Job Description:The position of Warehouse Team Member performs activities related to the receipt shipment movement manufacture or control of raw materials product recyclable materials and waste. Operates equipment/machinery when necessary.Responsibilities:Performs activities related t المزيد...

Responsibilities:Development of engineering Bill of Materials (BOM) in ERP management software.Identifying and quoting manufacturing methods and new materials with suppliers.Monitoring ordering and receipt of materials ensuring compliance and documentation.Coordinating engineering and المزيد...

Job Description:Seeking a Scientist with experience in regulated bioanalytical laboratories (GLP) to perform quantitative analysis of biological samples using HPLC-MS. The role involves sample extraction instrument operation data processing and documentation in compliance with GLP and المزيد...

Job Description:We are seeking a Principal Process Engineer with a strong background in GMP manufacturing and engineering.The ideal candidate will have hands-on experience in biologics process systems automation and utilities with a focus on upstream and/or downstream processes.The ro المزيد...

Note:Hours could be 20-40.Need to have night and weekend availability (primarily weekend) or doubles on the weekend 0645-2315.For orientation must have the ability to dedicate approximately 6 weeks on all 3 shifts for training.Job Description:Participate in the execution of protocol a المزيد...

Responsibilities:Follow all company safety rules regulations and job safety analyss.Must complete plant lock out procedures and key interrupt.Fill and operate shelf carton erector and clear minor jams.Responsible for quality of product including but not limited.Discarding obviously de المزيد...

Responsibilities:Perform scheduled and unscheduled maintenance on GMP assets and ensure proper documentation of all work performed.Troubleshoot equipment and system failures identify root causes and implement corrective and preventive actions.Coordinate equipment relocation efforts to المزيد...

Job Description:Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning /sanitizing. Monitor machine functio المزيد...

Responsibilities:Follow all company safety rules regulations and job safety analysis.Must complete plant lock out procedures and key interrupt.Fill and operate shelf carton erector and clear minor jams.Responsible for quality of product including but not limited to.Discarding obviousl المزيد...

Job Description:The Operations Specialist I is a multi-functional role responsible for inventory control of materials and finished goods formulation packaging and order fulfilment. The Operation Specialist I also supports Quality Control of finished goods by performing dye labelling r المزيد...

Responsibilities:Provides technical and sustaining engineering support in a manufacturing area.Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies manufacturing techniques as well as production yields for existing المزيد...

Job Description:We are seeking an experienced Cleaning Validation Subject Matter Expert (SME) to lead and execute cleaning validation activities in a dynamic biopharmaceutical environment. This role focuses on Cleaning-In-Place (CIP) processes cleaning validation execution and large e المزيد...

Responsibilities:Lead the development validation and maintenance of statistical programs using SAS to generate tables listings and figures (TLFs) for clinical trial data analysis.Develop and maintain SDTM domains in accordance with CDISC guidance.Create and optimize Adam datasets Tabl المزيد...

Responsibilities:Manage Phase I to IV study activities.Ensures the Master File is always inspection-ready and complies with ICH GCP guidelines.This role involves regularly updating and assisting study teams to address issues related to key Master File health indicators including the c المزيد...

Job Description:The chart review is critical and the candidate must have knowledge of reviewing medical records for disease process hanging blood and IV lines as well as critical care.Responsibilities:Responsible for maintaining compliance with FDA AATB international and state regulat المزيد...

Responsibilities:Responsible for the oversight of all data management CRO activities supporting companys clinical programs from database start-up through database lock and CSR/submission.Serves as primary point of contact with the DM CROs 3rd party vendors and internal study teams.Wor المزيد...