CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "cmc"

Pharmaceutical Chemist

Tags for this Online Resume: Chemist, Pharmaceutical Chemist, Scientist, CMC, Chemistry

Energetic, results-oriented individual with established credibility and respect at FDA and EMA. An extraordinary record which includes the lead and approval on New Drug Applications (NDA) and Marketing Authorization Application (MAA)

Global Regulatory Affairs leader for a combination of RA functions. Provides clear and specific regulatory input using skills(scientist, regulator and lawyer) to provide strategic planning decisions and implementation enabling successful drug approvals. Strong leader, expertise in DD, alignment with business goals, creative, proficient with complex frameworks and integration of abstract concepts in clinical and CMC areas o...

Tags for this Online Resume: Regulatory Affairs, small molecules, CDER, CBER, FDA, EMEA, IND, NDA, CTA, IMPD, proteins, anti-infectives, cardiovascular, pain, oncology, CMC, compliance, communicator, monoclonal antibodies , Biologics, Food and Drug, Global, eCTD, health authorities, alliance management, combination products, Biologics Biosimilars , Director , pharmaceutical , Leadership, Problem solving , Innovation, experienced, IND NDA CTA MAA, business goals , biologics - pharmaceutical , biosimilars

Biochemist

Tags for this Online Resume: Regulatory Affairs , FDA EMA, NDA MAA, Compliance , Clinical - CMC, Leadership, Experienced IND CTA, Proficient- Pragmatic , Innovation

Scientist or Manager

Biological Products, Quality, Bioanalytics, Vaccine, Cell line, biochemistry, manufacture, pilot plant, cell culture, fermentation, immunoassay, virus, influenza, nutrition, public health, cGMP, FDA, IND, CMC, BLA, clinical trial, pre-clinical, formulation, R&D

Tags for this Online Resume: biological, vaccine, quality, assay, manufacture, regulation

Quality Assurance/ Vendor Management Manager

Lead/manage Quality operations oversight for development of drugs at Contract manufacturing sites. Manage cross funtional teams internally and externally for timely release of products. In addition utilize my Quality Control/CMC regulatory experience for different size companies.

Research Scientist(Formulator) - experience of 5 years and 3 months in NDDS Injectable Products for Regulated Market .

I am Senior Research Fellow(Formulator) having an experience of 5 years in NDDS Injectable Products for Regulated Market. I have gain expertise in developing different formulation like Liposomal Injection, Lyophilized Injection, Ready to use infusion bag (LVP Injection), Oral suspension and Syrup.

Tags for this Online Resume: Formulation Scientist, Injectable Formulation Development, Formulation Development for Regulated Markets, ROW., Research Scientist, Liposomal Dosage Formulation Development, CMC Project Executive

Pharmacist - 13 Years of Experience - Near 500039

I want to continue in the pharmaceutical regulatory affairs CMC.

Chemist - 15 Years of Experience - Near 01778

Looking for a process chemistry and API delivery related research or management position using my expertise in organic synthesis, process development, API manufacture and CMC documentation in the biopharmaceutical industry.

Quality Assurance/Regulatory Affairs - 20 Years of Experience - Near 98109

Over 20 years in pharmaceutical and biotech *10 years research *U.S. and International Quality and Regulatory *Quality Auditing, domestic and international *Batch Review and Product Release *Investigations and CAPA *Contract Manufacturing Liaison, domestic and international *Successful building of Quality Systems *CMC and IMPD experience *Clinical Quality management *Quality Control, analytical development *Continu...

Tags for this Online Resume: Quality, Regulatory, auditing, Document Control, Vendor qualification, GXP, Device, Biologics