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Online Resumes with "CMC Documentation"
Principal Scientist/Analytical Project leader
Seek position in R&D as a analytical development team leader handling multiple projects, coordinate project activities with various departments (quality assurance, Reg. CMC, Clinical Manufacturing Unit, Drug supply management, technical operations and outside contract laboratories. Direct analytical method development and oversee analytical development for the formulation development at contract labs
Tags for this Online Resume: Publications, Diagnostics, Pharmaceutical, Research, Research and Development, Support, Technical Support, Audit, Compliance, Medical
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.
Research
To obtain a challenging position within the Pharmaceutical industry or medical devices industry that will allow me to use my experience to play a key role in Clinical Research studies and projects, and/or product development with medical devices.
Tags for this Online Resume: Clinical Pathology, laboratory method development, IQ, OQ, PQ, instrumentation, validation of medical devices, Regulatory, GLP, GCP, IRB, TMF, Project Manager, Documentation Specialist, Scientist, Archives
Scientist - 15 Years of Experience - Near 30045
PROFESSIONAL SUMMARY * Result oriented, Creative, Passionate, highly focused, experienced Pharmaceutical R&D Scientific Lead with good ethics, possessing over 15 years of experience in Formulation design, Process Development, Optimization and Scale up of various Pharmaceutical Dosage Forms, Solid Orals (IR and ER Tablets and Capsules), Liquid Orals (Solutions, Syrups and IR / ER Oral suspensions), and Parenteral formulation...
Tags for this Online Resume: Product Development, Filing, Pharmaceuticals (Generics), Formulation Research, Management, Budgetary, Process development, Oral solid dosage forms, Manufacturing, ANDAs
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 - 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
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
Regulatory Affairs & Operations Expert
My primary career objective is to work with organizations small to medium sized where I may use my versatile leadership skills to support company goals and objectives.
Ideal Companies: small to mid sized companies, such as Emergent
Tags for this Online Resume: Cancer, Microsoft, Microsoft Project, Documentation, Cardiovascular, Critical Care - Neurology, Legacy, Neurology, Pharmaceutical, Medical Device, Combination Products, Small molecule, Large molecule, biologics, vaccine, oncology, inhalants, oral, biotechnology, 505(b)(2), 510k, HIV, dermatology, regulatory, CMC, project manager, clinical, nonclinical
