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Online Resumes with "IND"
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
General - 13 Years of Experience - Near 10701
Summary of Qualifications Enthusiastic, self-starter with the ability to present products/ideas persuasively and build rapport. Flexible, multi-tasker with a strong work ethic and ethics and character of the highest caliber. Creative, attentive to the completion of precise tasks and projects. Enjoys taking initiative beyond stated job and is sensitive to needs of others. Qualified professional providing expertise in the lab...
Tags for this Online Resume: Technical Writer, Quality Assurance, Regulatory Affairs, Research, Compliance, Manufacturing, Quality, Quality Control, Documentation, Reliability, Research and Development, Document Control, HIV
Machinist
5yrs small Bridgeport mills and radial drills 5yrs turret lathe 7yrs vertical turret lathe 36" and 52" 23yrs horizontal boring mills 4' and 6' vertical travel. Also experienced with coppers stainless steels cast irons carbon steels & aluminum. I have worked with most types of hard face welding metals including hand applied and sprayed on. Very experienced in set up and all machining of split pump cases including all line bo...
Tags for this Online Resume: Blue Prints, Blueprints, Email, Turret Lathe, Valves, Vista, Welding
Clinical Regulatory Affairs - 2 Years of Experience - Near 02215
PROFESSIONAL SUMMARY: A Regulatory Project Manager with 2+ years of managing IND/NDA/BLA review processes and 1+ years of cGMPs experience in pharmaceutical industry. Deadline-driven and highly reliable professional, successfully managing over 300 applicants' submissions in IND, NDA, BLA, and BSE as well as participating in 4 cGMPs sponsors' inspections (Japan and Taiwan) and 1 FDA inspection at manufacturing plants. Great ...
Tags for this Online Resume: Compliance, Pharmaceutical, Project Management, Regulatory affairs, CMC, NDA, IND, BLA, cGMP, GCP, ICH
Financial Manager, Branch or Department - 20 Years of Experience - Near 70563
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Tags for this Online Resume:
Automotive, Forecast, Link Access Procedure (LAP), Management, Microsoft, SAP MM module, Teller, Typing, Sales, Customer Service
As a leader of projects in Pharma discovery and pre-clinical efforts, I have managed functional activities and provided scientific direction from drug discovery concept to FIH. I contributed to an IND for the project I led. I am an inventor on the filed US patent.
In June 2017, the second patient was dosed with this exploratory medicine.
In my current and previous roles, I have had the opportunity to coordinate internal an...
Tags for this Online Resume:
Immunology, Management, Research, Data Management, Process Improvements, Pharmaceutical Industry, oncology, pharmaceutical, project leader, project manager
Results-oriented and data-driven medicinal chemist, project manager and group leader with proven success supporting the IND candidate and identifying a back-up candidate in 2 years. Recognized for meeting/exceeding corporate expectations through strong management/project coordination and effectively working with cross-functional, global teams in a matrix organization. Effectively utilizes oral, written, organizational and... 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
CAREER SUMMARY * Senior, seasoned pharmaceutical R&D professional with strong administrative, strategic & scientific planning, and coordination/execution skills, gained through 27 years of industrial experience in leading CMC technical development function (Pharmaceutics & Analytical), and leading global development & regulatory filings for NMEs (small molecule and biologics / mAb), and 505 (b) (2) products strong expertise...
Tags for this Online Resume:
CMC, Product Development, Regulatory Affairs, Good Manufacturing Practices, Management, Project Management, Technical Lead, DP, Product Development, Supply Chain, Technical Operations
DeMillus S/A Indústria e Comércio -
Tags for this Online Resume:
Purchasing, Buying, Cash Flow, Oracle, Recruiting, Sourcing, Procurement, Planning, CFO, Inventory, manager
PROFESSIONAL SUMMARY * A proven leader with a track record of accomplishments with more than fifteen years pharmaceutical industry experience in leading analytical development activities for small molecule drug development * Hands-on experience in analytical project management in drug development and regulatory submissions hands- on experience in analytical method development/validation/transfer in GMP environments expertis...
Tags for this Online Resume:
High Performance Liquid Chromatography (HPLC), Quantify, Analytical Chemistry, Chemistry, Research, Research and Development, Regulatory Affairs, Applications, CMOS, Development Activities
Summary * Project Officer and Work Assignment Manager human health toxicologist in the in the U.S. Environmental Protection Agency's (USEPA) Office of Water (OW) to support agency products registration and other regulatory activities * Developed human health benchmarks for registration/regulation of drinking water and environmental contaminants for the USEPA * Developed multivariate computational toxicology in silico QSAR m...
Tags for this Online Resume:
Risk Assessment, Management, Toxicology, Integrate, biologist, toxicologists, Assessments, Cancer, Data Analysis, Database, ESA
Biophysicist - 20 Years of Experience - Near 21791
Senior Medicinal Chemist
Health Technologist - 7 Years of Experience - Near 02176
Clinical Pharmacovigilance/Drug Safety - 20 Years of Experience - Near 95117
Purchasing Manager - 20 Years of Experience - Near 34787
Chemist - 20 Years of Experience - Near 02467
Life Scientist - 20 Years of Experience - Near 20721
