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Online Resumes with "Biologics Manufacturing"



Microbiology Professional

Seeking a scientist or entry-level pharmaceutical sales position where my experience in quality assurance microbiology can be utilized. Interested in equipment validations.

Ideal Companies: Abbott, Astra Zeneca, Bristol Myers Squibb, Johnson and Johnson, Merck, Pfizer

Tags for this Online Resume: Microbiology, Biology, Quality Assurance, Quality Control, Laboratory Supervisor, Endotoxin, Microbial Identification, Aseptic Processing, Pharmaceutical/Biotech, LIMS, SAP

Analytical Chemist--over 34 years of experience

To utilize my knowledge and work experience in chemical and biological manufacturing units.

Production Supervisor 9 years in Pharmacuetical/Biological Manufacturing

Senior Scientist - M.S. Biologist, medical diagnostic industry, 20+ years experience. R&D, Manufacturing, Quality Assurance, Technical Support, and Quality Systems.

M.S. Biologist, molecular biology background, medical diagnostic industry. Experienced in R&D, Manufacturing, Quality Assurance, Technical Support, 21 CFR 820, audits, submissions and FDA communications. Proficient in technical reports, documentation, presentations, analytical instrumentation (HPLC, CE, UV-VIS), statistics (JMP, DOE, SPC, specifications), immunoassay development (ELISA, purification, conjugation), test meth...

Tags for this Online Resume: Medical Device, Quality, Auditing, molecular biology, manufacturing, regulatory, Quality/Regulatory, Biologics Manufacturing, MicroBiology/Environmental Monitorrig, Regulatory Affairs

Senior Manager_ Biologic Manufacturing

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

Featured Profile

Doctorate in Management in Organizational Management. Currently Sr. Project Manager in the pharmaceutical industry in biologics and Previously in solid dosage. Military Officer (retired)

Veteran Leader and Professional with over 33 years’ experience in Industrial Engineering, Logistics, Maintenance (electrical and mechanical), Process Engineering, training and development of personnel, pharmaceutical solid dosage and biologics manufacturing and Lean Six Sigma. Accustomed to working within a team based environment and independently as required. Extensive background in equipment and facilities installation, o...

Ideal Companies: Novartis, Pfizer, Celgene, Merck, Johnson and Johnson, Bayer, M&M Mars, Amazon, and Civil Service

Tags for this Online Resume: Engineering, Industrial Engineering, Management, Pharmaceutical, Support, Technical Support, Electronics, Control Systems, HVAC, Change Control, Leadership, CAPA, Deviation investigation and management, Root Cause Analysis, Logistics management, Calibration, Qualification and Validation, "project management", reliability, maintenance, production, manufacturing, Validation, IQ/OQ/PQ/PV, Process Improvement, Lean Six Sigma Black Belt, Doctorate in Management in Organizational Leadership

Featured Profile

Manager

Experienced engineering executive with a commitment for continuous improvement, customer satisfaction and cost-effective solutions in the fields of Engineering, Maintenance, Operations, Facilities, Safety, Environmental and Manufacturing Operations Support Management and Reliability, seeking to leverage these strengths and opportunities in an organization driven to achieving excellence.

Ideal Companies: Johnson & Johnson, Amgem, Bristol Myers Squibb, Catalent, Cardinal Health, Teva, VPX Pharmaceuticals

Tags for this Online Resume: Infrastructure, Landscaping, Quality, Quality Assurance, Quality Control, Engineering, Program Manager, Services, Facilities, Utilities, Maintenance, Manager, Director, Plant