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Online Resumes with "QbD"
Analytical Chemist
Molecular spectroscopist and technical project team leader supporting global product development, quality improvement, and process engineering through innovative application of advanced spectroscopic techniques, Process Analytical Technology (PAT), and Quality by Design (QbD). Recognized for creativity, motivational leadership, mentoring and supervisory skills, enthusiasm, high throughput, working with cross-functional tea...
Tags for this Online Resume: analytical, spectroscopy
Regulatory Affairs, Analytical Development R & D, Quality and Compliance
To contribute to improving business success
Ideal Companies: Pharmaceutical drug product manufacturing/consumer products manufacturing/API
Tags for this Online Resume: Leadership, Regulatory Affairs, Quality, Compliance, Analytical Development, Research and Development
Aircraft Rigging Assembler
Tags for this Online Resume: pharmaceutical industries, QA supervisor, floor QA, Qbd, CAPA, root cause analysis, Validation specialist- process, equipment, cleaning validation, M-file, minitab, GMP , Team work, adjustable
F1 Student on OPT looking for entry level position
I aim to make my career in Pharmaceuticals/Medical Device/Biopharmaceutical Industry. Presently I am looking for position where I can implement some very new and effective skills that I have learned from my industrial experience as Quality Control Analyst and Validation Project Manager at Stevens Pharmaceutical Research Center. I am good at tools like Lean Six Sigma, CAPA, FMEA, SPC, QbD and Validation expertness like IQ, O...
Principal Scientist/Analytical Project leader
Seek position in R&D as a analytical development team leader handling multiple projects, coordinate project activities with various departments (quality assurance, Reg. CMC, Clinical Manufacturing Unit, Drug supply management, technical operations and outside contract laboratories. Direct analytical method development and oversee analytical development for the formulation development at contract labs
Tags for this Online Resume: Publications, Diagnostics, Pharmaceutical, Research, Research and Development, Support, Technical Support, Audit, Compliance, Medical
Director of Quality - 20 Years of Experience - Near 91325
To utilize my Education, professional experience and expertise on pharmaceuticals, Nutraceuticals, and Personal care products to improve productivity and reduce production cost by managing rework, waste control and proper schedule to finish the assign job on time. Extensive practical experience in formulation, Development, Optimization, Scale-up, Validation and tech-transfer activities for the following: *Generic pharmaceu...
Tags for this Online Resume: Director Research and development and production, cGMP, GMP, SOP, CMC, QBD, Quality by Design, scale up, validation, Monitoring, DMF, CTD, drug master file, Injection, parenterals, Lyphilization, Tablets, Capsule, Cosmetics, cream, lotion, gels, softgel, powder for drinks, Liposoms, ethosoms, Sustain Release tablet, control release tablet, Granulation, compression, Coating, Formulation, production, Medical device, Drug loading, drug delivery, Autoclave, ETO gas sterilization, steam sterilization, Heat sterilization, Depyrogen sterilization, Large volume parenteral, small volume parenteral, ophalmic ointment,eye drops,
Scientist - 15 Years of Experience - Near 30045
PROFESSIONAL SUMMARY * Result oriented, Creative, Passionate, highly focused, experienced Pharmaceutical R&D Scientific Lead with good ethics, possessing over 15 years of experience in Formulation design, Process Development, Optimization and Scale up of various Pharmaceutical Dosage Forms, Solid Orals (IR and ER Tablets and Capsules), Liquid Orals (Solutions, Syrups and IR / ER Oral suspensions), and Parenteral formulation...
Tags for this Online Resume: Product Development, Filing, Pharmaceuticals (Generics), Formulation Research, Management, Budgetary, Process development, Oral solid dosage forms, Manufacturing, ANDAs
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Scientist - 5 Years of Experience - Near 08830
PROFESSIONAL SUMMARY * Experience in design and development of variety of dosage form semi-solid (cream, lotion, gel, ointment), liquid (solution, suspension) and nasal spray. * Experienced in preformulation, characterization and formulation optimization using solubility, skin diffusion, in-vitro diffusion, viscosity, yield stress, pH etc. * Designed Quality Target Product Profile (QTPP) and identified Quality Attributes (Q...
Tags for this Online Resume: Manufacturing, Quality of Service, Distribution, SEMI, Assessments, Centrifuge, Development Activities, DSC, Good Laboratory Practices, High Performance Liquid Chromatography (HPLC), pharmaceutical, research
Director - 20 Years of Experience - Near 08520
ACCOMPLISHMENTS * Lead client teams and CDMOs in Product Risk Assessments, EHS Analyses, Regulatory Audits, FDA PAI readiness program, interfaced with US Environmental Protection Agencies for new and updated Air Emission and Wastes Water Effluence permits. Manage OSHA training and audit programs. Reduced product technical and compliance risks while saving safety-related operating cost by reducing planned budget by >10%. Ben...
Tags for this Online Resume: Engineering, Manufacturing, Compliance, ECMS, HVAC, Infrastructure, Material Handling, OSHA, Business Development, Management, director, consultant, regulatory compliance
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
