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Online Resumes with "technical transfer"



Production Manager - 18 Years of Experience - Near 02725

SUMMARY Eighteen years experience in Manufacturing or Manufacturing support, including over ten years of supervisory experience. Proven ability to drive production against aggressive schedules while rigorously maintaining safety, quality, and regulatory standards. Expertise in training, documentation, and technical transfer functions. Familiarity with Lean Manufacturing and continuous improvement initiatives. Extensive expe...

Tags for this Online Resume: Documentation, Good Manufacturing Practices, Support, Compliance, Housekeeping, Management, Utilities, Evaluate, Kaizen, Lean Manufacturing

Clinical Research - 20 Years of Experience - Near 11554

SUMMARY Extensive management and technical experience with pharmaceutical companies in the areas of Quality Assurance, Quality Control, Manufacturing Support and Product Development. Back ground includes: * Risk Management * Process Improvement Projects * Clinical Investigator Site Audits GCP/GMP/PV Internal/ External Audits * Documentation audits * GMP, GCP Deviations/Investigations Change Control Management * Complaints H...

Tags for this Online Resume: Budget Preparation, Budgeting, Test, Compliance, Good Clinical Practices, Documentation, Technical Documentation, Packaging, Process Improvement

Life Scientist - 18 Years of Experience - Near 43054

Managed and worked in multidisciplinary scientific and business teams with 20 years of academic and industry experience continuously proving by filing patents (5+) publishing articles in peer-reviewed journals (16) and presenting in international/national conferences/meetings (15+) Conceived developed project plans after in depth literature analysis designed and conducted research experiments documented protocols/methods an...

Tags for this Online Resume: ELISA, High Performance Liquid Chromatography (HPLC), CMOS, Filing, Manufacturing, Microsoft, Microsoft PowerPoint, PDB, Scientist and Management, Molecular Biologist, Protein Biochemist

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

Manufacturing Management and Engineering professional focused on executing business plans with emphasis on maximizing profitability and continuous improvement. Proven ability to direct and motivate teams for success.

Areas of Expertise Cross-Functional Leadership, Performance Management, Technical Transfer, Project Management, Facilitation, Management in Regulatory Environments, Innovation, Best Practices, Lean Certified, P & L Management and Cost Control Strategies, Safety & Risk Management, Product Development & Product Launch, Labor Relations & Union Negotiations, Preventative & Predictive Maintenance, Engineering Leadership, Cash ...

Tags for this Online Resume: Manufacturing, Engineering, Quality, Supply Chain, Lean Manufacturing, Operations Management, Chemical Engineer, Cost Savings, Cash Flow Management, Packaging, Processing, Engineering Management

Chemist

Tags for this Online Resume: Quality Assurance, Test, Complaints, Quality, Quality Control, Risk Analysis, Compliance, Manufacturing, Pharmaceutical, Documentation

Featured Profile

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

Operations Manager - 20 Years of Experience - Near 77433

Tags for this Online Resume: Management, Logistics, Recruiting, 5S, Assessments, Manufacturing, Budgetary, Engineering, Lean Manufacturing, Manufacturing Engineering