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Online Resumes with "cGMP Manufacture"
My Objectives are to advance in the Biotechnology field. My current role is managing two cGMP manufacturing facilities and critical utilities, Currently half way through my Masters of Science in Facilities Management, my goals are to raise the bar to a more challenging role in the management field in the Pharmaceutical Industry.
I am a highly accomplished science professional who would like to use my 15 years of experience designing and implementing Quality Systems and Environmental Health & Safety Programs to manager a companies facilities and/or product quality, regulatory and safety compliance. I can leverage my extensive knowledge of quality and safety systems to manage all levels of both product and process implementation including, documentat...
Ideal Companies: Ideal companies I would like to work for will be in the science and technology sector within a 30 mile radius of zip code 06405. Examples of large companies include Covidein (North Haven), Phillips (Meridan), Perkin Elmer (Shelton), Unilever (Trumbull), BMS (Wallingford). Smaller companies are concentrated in Wallingford, Meridan, Milford and New Haven. Yale, Southern Connecticut State, and Quinnipac Universities are also potential opportunities.
Tags for this Online Resume: Quality Assurance, FDA Compliance, EHS Management, Strategic Planning, Research and Development, Operations Management, Project Management, Cross-Functional Leadership, Technical Support/Writing, Customer Satisfaction, Continuous Process Improvement, Team Building/Training and Mentoring
I am an experienced professional scientist with over 25 years of Research and Product Development and cGMP manufacturing experience in the pharmaceutical and biotechnology industries. I have a proven track record of directing and delivering high profile multi-million dollar projects and contracts on time or ahead of schedule and meeting exacting specifications (purity, potency and quantity of purified biologics).
Tags for this Online Resume: Philadelphia, PA, Process Development, Monoclonal manufacturing, Viral removal technology, Viral Vectopr Manufactrunig, Upstream Bioreactor Process, Downstream Chromatographic Purification
Given the experience I have I can be of tremendous value and hit the ground running making a substantial impact in just a few months once I learn and understand your systems.
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...
Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
PROFILE Experienced Project Scientist/Manager with strong background in neurodegenerative diseases, vaccine development, protein expression, analysis and production. A seasoned expert in animal models of neurodegeneration, protein biochemistry and cGMP manufacturing. Excellent team player and communicator, able to meet ambitious goals while successfully working in a matrix organization. Possess significant experience in pla...
Tags for this Online Resume: Manufacturing, cGMP, Documentation, Conferences/Events, Project Management, Research, Cancer, Protein Biochemistry, Biologics, Budgeting, Animal models, Neurodegenerative diseases, Drug development
SUMMARY * Current graduate student working on second master's degree in Regulatory Affairs for acquiring general insights of regulatory profession and in-depth practical knowledge of regulatory compliance, including CMC (Chemistry, Manufacturing, and Controls) and quality system practices. * Extensive background in the biopharmaceutical industry and 3-year experience in upstream bench-scale cell culture process development ...
Experience Summary Senior Leader with extensive knowledge of engineering, programming, estimating, contracts, procurement & construction relative to planning and executing major capital expansion programs. An excellent track record of directing large, complex projects related to heavy industrial, power utilities, clean-room manufacturing, custom equipment, high-purity piping systems, buildings & infrastructure. A strong pro...
Summary With a Background of clinical medicine, molecular biology & Naturopathy, Evaluation of natural ingredients with scientific knowledge for safety & clinical based efficacy has been my core interest. Formulation development and manufacturing management of nutraceuticals and cosmaceuticals with cGMP HACCP application/compliance has been my major professional engagement. - Experience & Expertise in cGMP manufacturing man...
Tags for this Online Resume: Herbal medicine, Research and Development, Manufacturing, Microsoft Internet Explorer, formulation development, Nutraceuticals, Cosmaceuticals, Herbal extraction, Molecular Biology, Pharmaceutical Industry
QUALIFICATIONS * Proactive and results-oriented pharmaceutical manufacturing and production supervisor with 14+ years of experience overseeing all teams and operations to ensure accuracy, quality, and safety within high-volume, challenging pharmaceutical manufacturing. * Efficient prioritizing, organizing and multi-tasking skills developing process improvements, implementing new procedures, focusing on safety, and implement...
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA