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Online Resumes with "Large molecule"
My skills in R&D and cGMP experiences with the following analytical techniques; HPLC (Agilent & Waters, using Empower), GC (Agilent & Perking Elmer), ICP-OES (Perkin Elmer), Dissolution and other analytical test. I am currently working on large molecules (cIEF), troubleshooting methods and instrumentation problems; developing and executing validation plans; carrying out method transfers; and method development.
Large molecule cancer drug discovery, cell based as well as in vitro assay development and validation, mouse xenograft experience. Effective communicator with exceptional people skills.
To use my drug development experience to design and interpret preclinical programs. I enjoy designing programs for both small and large molecules, looking at the particular compound and indication, timelines and budgets and then working a group to implement the program within the requirements of manufacturing, CMC, regulatory and clinic.
I am seeking for a position in an organization to continue to develop my skills and apply the knowledge and experience that I have gained for the future success of the organization. Experience in preformulation studies, formulation development of small and large molecules, preclinical pharmacology (in vivo testing and pharmacokinetic studies). Highly focused with excellent oral and written communication skills.
Tags for this Online Resume: formulation development, drug delivery , small and large molecules, HPLC, DSC, lyophilization, nanoparticles, ELISA, SDS-PAGE, Dynamic light scattering, UV-Vis / Fluorescence spectroscopy, tumor cell signaling
Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...
Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures
SUMMARY Successfully led the Operation of Research and Development in generic and branded pharmaceutical companies for more than 15 years. Successfully managed all activities in pharmaceutical companies including: formulation development, analytical, quality control, Quality Assurance, Process Validation, Stability, Scale up, Manufacturing, & clinical studies to support US submissions for ANDAs, NDAs, INDs. Effectively mana...
Summary Highly motivated, dedicated and results oriented sales and marketing professional with over eighteen years experience in Contract drug development and manufacturing, Engineered process equipment and Separations Technologies. Global thinker with strong business development experience. Dynamic self- starter with outstanding leadership and communication skills collaborating with multicultural, cross- functional teams t...
Tags for this Online Resume: Sales, Sales Engineer, Business Plan, Engineering, High Performance Liquid Chromatography (HPLC), Process Engineering, Heat Exchangers, HVAC, Mining, Pharmaceutical Industry, ACCOUNT DIRECTOR, DRUG DEVELOPMENT
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
My primary career objective is to work with organizations small to medium sized where I may use my versatile leadership skills to support company goals and objectives.
Tags for this Online Resume: Cancer, Microsoft, Microsoft Project, Documentation, Cardiovascular, Critical Care - Neurology, Legacy, Neurology, Pharmaceutical, Medical Device, Combination Products, Small molecule, Large molecule, biologics, vaccine, oncology, inhalants, oral, biotechnology, 505(b)(2), 510k, HIV, dermatology, regulatory, CMC, project manager, clinical, nonclinical