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Associate Director Biotech Validation Jobs

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Job Description: This position will provide technical and strategic stewardship, mentorship, and oversight of the Validation and Qualification Operations at the Akorn India Manufacturing site. The role involves use of risk-based approaches to define and assess validation and qualification processes and controls for existing and new facilities, equipment, processes, and critical systems. Responsib...
Kite Pharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T ce...
Validation and Instrumentation Technologist University of Wisconsin - Madison Position Vacancy Listing PVL # 86373 Degree and area of specialization: Bachelor's degree is required; MS/PhD preferred in Engineering, Microbiology, Molecular Biology, or a related field. Minimum number of years and type of relevant work experience: Well-qualified candidates will have the following preferred exper...
About Lonza Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life. Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharm...
About Lonza Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life. Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharm...
Job Description: This position will provide technical and strategic stewardship, mentorship, and oversight of Microbiology programs employed at the Akorn India Manufacturing site. The role involves use of risk-based approaches to define and assess microbial controls for existing processes and new installations. Responsibilities will include developing and implementing targeted process improvement...
Job Description: This position will provide technical and strategic stewardship, mentorship, and oversight of Sterile Operations and Aseptic Processing at the Akorn India Manufacturing site. The role involves use of risk-based approaches to define and assess aseptic and process controls for existing processes and new installations. Responsibilities will include developing and implementing targete...
Job Description: This position will provide technical and strategic stewardship, mentorship, and oversight of Quality Control Laboratory programs employed at the Akorn India Manufacturing site, with respect to laboratory testing, chemical analysis, and investigation analysis. This position provides guidance and technical expertise to QC Chemistry personnel in all areas of their Quality Control fu...
Overview: Why Join Us Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rate and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. We are launching five Phase 2 clinical trials and with another preclinical trial in the pipeline. Where possible, our strategy is to acquire and retain ...
Description • Accountable for providing strategic direction, leading and coordinating activities involved in the design/development, validation and implementation of best-in-class Microbiology and Molecular Biology applications for clinical and commercial Biologics products. Ensure compliance readiness and governance of Microbiology assays across the Biologics Organizational Unit (OU). • Account...
General Position Summary/Purpose: Responsible for the planning and tracking the Statistical Programming staff activities Manage and coordinate the Statistical Programming staff to ensure efficient use of the resource and work flow Build and enforce the appropriate standards in the department Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Over...
Associate Director / Director / Senior Director, Biological Sciences Epizyme, named a Fierce 15 company by Fierce Biotech, ranked #1 and #2 worldwide by The Scientist in "Best Places to Work Industry”, and most recently named Innovation All Star by the Boston Business Journal, has grown successfully since its founding in 2007 in Cambridge, MA. Epizyme is a clinical stage biopharmaceutical company...
Associate Director / Director / Senior Director, Biological Sciences Epizyme, named a Fierce 15 company by Fierce Biotech, ranked #1 and #2 worldwide by The Scientist in "Best Places to Work Industry”, and most recently named Innovation All Star by the Boston Business Journal, has grown successfully since its founding in 2007 in Cambridge, MA. Epizyme is a clinical stage biopharmaceutical company...
The Product Champion (PC) has a commercial biologics product(s) focus and owns the technical product and process knowledge of the assigned product(s) manufactured by third party manufacturers throughout the commercial lifecycle. This is performed by oversight of process capability through data trending and statistical analysis of critical parameters to ensure process(es) are robust, in continued s...
Overview: Alnylam is a midsized and rapidly growing biotechnology company in Cambridge, MA focused on the discovery and development of RNAi therapeutics. The Bioanalytical Sciences department at Alnylam is recruiting an Associate Director or Director, reporting to the Senior Director, to join our fast-paced team to advance our RNAi therapeutic programs from discovery to the clinic. The successful...
Makro Scientific is looking for Medical Lab Technologist to work on a contractual basis for a fortune 500 pharmaceutical company. Job Overview: Job Title: Medical Lab Technologist Location: New Haven, CT Duration: 12 Months (Possibility for extension) Job Description: SKILLS: 1) Perform all routine and special clinical chemistry, hematological, coagulation, and urinalysis and other tests ac...
General Position Summary/Purpose: Responsible for the planning and tracking the Statistical Programming staff activities Manage and coordinate the Statistical Programming staff to ensure efficient use of the resource and work flow Build and enforce the appropriate standards in the department Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Over...
Let’s Make Things Happen! Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies. Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the ind...
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ir...
Associate Director/Director, Lead Discovery Epizyme, named a Fierce 15 company by Fierce Biotech, ranked #1 and #2 worldwide by The Scientist in "Best Places to Work Industry”, and most recently named Innovation All Star by the Boston Business Journal, has grown successfully since it’s founding in 2007 in Cambridge, MA. Epizyme is a clinical stage biopharmaceutical company creating targeted epige...