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Online Resumes with "Antibody drug"
Regulatory Affairs, Boston
I am an experienced Regulatory Affairs Professional with knowledge regarding drugs, biologics and medical devices. I have exceptional knowledge in manufacturing, process development, quality control, and assay development. Possess a strong technical background including proteins, monoclonal antibodies, drug analytes, oligonucleotides and medical devices. I am hard-working, highly productive, detailed oriented and success...
Associate Scientist
My current objective is to procure a position that utilized my existing experience/skill base and offers opportunity to learn new skills. I have 14 years of diagnostic, bio-pharmaceutical, and device experience which includes development, validation, transfer, CMC involvement. I have also managed a group responsible for the development of analytical test methods utilized to monitor and release antibody drug products in a ...
Senior Bench Scientist
Highly adaptable and innovative life scientist manager with excellent leadership and communication skills.
Ideal Companies: Wyeth, Genzyme, Novartis, Corning, BD, Elixir Pharmaceuticals
Tags for this Online Resume: cell biology, cellular assay, biochemical assay, application scientist, drug discovery, cell culture
Biologist - 15 Years of Experience - Near 08831
PROFILE: * Molecular biologist with experience in protein chromatographic analysis with >12 years of industrial experience * Protein characterization, including protein chromatographic methods, protein purity determination, competition analyses, binding activity and post-translational modification (PTM) risk assessment * Responsible for assessing and developing new technologies and tools for antibody and drug discovery * Ex...
Tags for this Online Resume: Banking Industry, Support, Certified Insurance Counselor, Construction, Data Analysis, Data Management, ELISA, Focus, Management, Research
Life Scientist - 20 Years of Experience - Near 94002
Accomplishments: * Actively consulting on, discovery and development of Antibody Drug Conjugates (ADCs) * Actively consulting on, small molecules process optimization, scale-up and regulatory aspects * Sepsis diagnostic kits (mAb based) business to Asia for development, manuf. and marketing. Consulting and Project Management * API Process Dev - (Malvern, PA) DP Formulations - Horizon Therapeutics (CA) * Duexis Tabs launched...
Tags for this Online Resume: Cancer, Adc (Advance Data Comm), Consulting, Outsourcing, Pharmaceutical, Management, API, Manufacturing, Application Program Interface, pharmaceutical, biotech, drug development, operations, regulatory
Health Technologist - 7 Years of Experience - Near 02176
Associated Scientist_ Protein formulation and drug product development 2017 - present Shire Provided formulation and process development support for two injectable monoclonal antibody drug product development programs. Designed executed and communicated results of formulation robustness study pH range study PS80 range study. * Executed and communicated results of stability and comparability studies including evaluation of d...
Tags for this Online Resume: Cancer, Manufacturing, Packaging, Product Development, Integrate, Quality, Quality Assurance, Test, Assessments, Pharmaceutical
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
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...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
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
