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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

Department Manager - 20 Years of Experience -

I am seeking a professional position in a management role that leverages my 20 plus years of quality, manufacturing & training skills in a highly regulated environment. I seek an employer who values work ethic, emphasizes detail oriented skills and promotes employees who are seen as value added assets.

Ideal Companies: Core RX, Valeant, Catalant, Baxter, Watson, Thorne Research

Tags for this Online Resume: Quality Manager, Pharmaceutical Manufacturing, Investigations, Customer Complaints, Leadership, Management, Problem Solving, Complaince, detail oriented

Head of Quality looking to refocus

I am applying for an upper management position within the Quality Department. • Experienced research and development. A scientist who successfully transferred knowledge, skills and experience in industry for new product development and processes in Pharmaceuticals and Nutritional Supplements. • More than fifteen years of managerial experience, which includes functioning with both domestic and global cross-cultural gr...

Tags for this Online Resume: Complaints, Documentation, Audit, Inventory, ISO, Manufacturing, Procurement, Quality, Quality Assurance, Quality Control

QA Professional - Former FDA CDER 15 years experience, ASQ CQE, CQA, CQMgr-OE, Microbiologist,- DC

Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits

Ideal Companies: Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer

Tags for this Online Resume: TrackWise, Investigations, CAPAs, APRs, Minitab, SPC, SAS-JMP/Discovery, SAP, QA, Compliance, Medical Device, Pharmaceuticals, Biotechnology

Engineering Manager - 31 Years of Experience - Near 85224

Engineering project manager with 25 years' experience designing and manufacturing medical devices and 6 years' experience in business ownership and sales. Driver of all aspects of projects from gathering customer requirements to production release. Specialist with Class II and III combination products. FDA-recognized expert with Design Controls. Highly skilled people and situation manager. Leader at coordinating all depart...

Ideal Companies: Medical Device Companies, Employees 0f 100-250

Tags for this Online Resume: Microsoft Windows, Design Controls Expert, Engineering Project Manager, CAPA Investigator, Technical Sales, ISO 13485, ISO 14971, Internal and Vendor Auditor, FMEA, 510(k), Patents

Assistant Director - 10 Years of Experience

Join an organization that will take advantage of my experience and education. Versatile professional with more than 20 years experience selling both domestic and internationally education programs. Excellent communicator as evidenced by a serving as an instructor at institutions of higher learning and private language schools.

Ideal Companies: Climber.com, UCSD

Tags for this Online Resume: consultative, sales, research

Experienced Quality Assurance Engineer

Experienced Quality Assurance Engineer With demonstrated history of working in the consumer electronics industry, Skilled with HP,JIRA, Quick Test Professional(QTP), RMA Agile Methodologies, And detail knowledge about FDA procedures in Quality Engineering.

Tags for this Online Resume: MySQL, Java, Jira, ISO 13485, FDA, Systems Testing, C#