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Online Resumes with "FDA Approval"
Sales Manager
Career Summary: * 10+ years of experience in Semiconductor Marketing Strategies and Sales, Field Operation, Product Management, Manufacturing, Technology Roadmap, Customer and Business Development. * 7+ years experience of research and development in field of: Semiconductor System, RF and Microwave Plasma Modeling, Wireless Device, Manufacturing Implementation, Sensory and Monte Carlo Statistical Simulation. * 3+ years expe...
Tags for this Online Resume: Support, Rf, Sales, Budget Control, Budgeting, Capital Equipment, Cardiovascular, Construct (App Dev Tool), Consultative Sales, Data Modeling
Program Manager
ACCOMPLISHMENTS Seven years Medical Device Experience * Led team for 510K FDA approval on a medical robotic stent delivery system * Launched Digital Signal Processor medical device, met medical device quality requirements, built strategic alliances, achieved 510K FDA approval, and improved market share 25% * Cut development time by 50%, coordinated groups in 3 countries for design reviews, developed parallel activity with c...
Tags for this Online Resume: Reviews, Risk Management, EMC, Management, Program Management, Risk Assessment, Macromedia Flash, Product Launch, Program Manager, Quality
Scientist - 15 Years of Experience - Near 10954
SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished ...
Tags for this Online Resume: Enterprise Requirements Planning, Information Requests, Oracle, Oracle ERP, DSC, Product Development, Research, SAP, Filing, regulatory
Scientist - 15 Years of Experience - Near 10954
SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished ...
Tags for this Online Resume: Enterprise Requirements Planning, Information Requests, Oracle, Oracle ERP, DSC, Product Development, Research, SAP, C Programming Language, Filing
Life Scientist - 15 Years of Experience - Near 20782
PROFESSIONAL SUMMARY Exceptional leader talented at building professional relationships, self-motivation and team goals. Technically-savvy with outstanding training and presentation skills. Motivated scientist with solid experience managing all levels of large scale projects, including budgeting and administration. Experienced Scientist professional with strong leadership and relationship-building skills. Meticulous Medical...
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Manufacturing, Cellular, Documentation, Electrophoresis, ELISA, Therapy, Training
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval for a respiratory biologic and successful IND submissions. Extensive and broad based expertise in conceptualizing and desig...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices, oncology, protocol, pharmaceutical, ich, nonclinical, Regulatory Affairs, Quality Assurance, GXP
Life Scientist - 20 Years of Experience - Near 19335
Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval and successful IND submissions. Extensive and broad based expertise in conceptualizing and designing nonclinical developmen...
Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices
Software Engineer - 1 Years of Experience - Near 95008
QUALIFICATIONS: Experienced project architect/manager/engineer/ with thirty+ years of experience in design and testing Managed teams of three to twelve engineers in numerous electronics/software manufacturing companies Thirty-two years of diversified MS Windows application development ( Visual Studio C# Visual C++ C ) Designed first FDA approved automatic blood pressure regulator (AI expert system) for ICU patients IVAC Dev...
Tags for this Online Resume: Reliability, System design, WPF, SAN (Storage Area Network), Surgical, ICU, Microsoft Visual Studio, Structured Query Language, Microsoft SQL Server, Microsoft Windows
Specialty Sales Representative-16 years Experience-Omaha, NE
Highly motivated, specialty sales representative, with a well documented sales history while promoting a variety of therapeutic products within the pharmaceutical and biotechnology markets.
Ideal Companies: Amgen, Genentech, Gilead, Genzyme, Johnson & Johnson, Calgene, Abbott Labs, Aptalis
Tags for this Online Resume: Pharmaceutical Sales, Buy and Bill , Hospital Sales , IV and IM, Omaha, Product Launches, Biotechnology Sales, Pharmaceutical, Sales, Gastroenterology
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
Director of Human Resources - 20 Years of Experience - Near 94538
Hello, I am looking for the next step in my career. I am looking for a progressive organization that values input and is in a state of change. I desire a leadership role where accomplishments are recognized and appreciated.
Tags for this Online Resume: Compensation, Generalist, Leader, Recruiting, Bio Pharmacy, Training and development, Benefits, Organizational Development, Job Matching, Human Resources, Technology
Operations Expert 15 Years | Franchise | Training | Drive For Results
Strategic, visionary, make-it-happen leader. Analytical problem solver. Develop solutions to improve efficiency and accuracy. Effective team leader able to effectively and efficiently manage operations to achieve planned goals for integrity, revenue, maintenance of company standards for customer satisfaction, quality assurance, and asset protection. Critically evaluate and minimize operational costs in context of organizati...
Ideal Companies: Walmart , Costco , VisionWorks, Disney , Universal
Tags for this Online Resume: Strategic Business Planning, Top Line Sales, Professional Networking, Motivating and Influencing, Improving Customer Satisfaction, Directing Marketing Messaging, Strengthening Brand Awareness, Business Turnaround Specialist, Team Building, Coaching, Leadership, Employee Engagement
