From: Windsor Southfield [mailto:wssc82@ Service Co. Office: (248) 661-4174 Email: We are executive recruiters nationwide and are recruiting for a number of positions. Attached is a list of some of the positions currently available. If you or someone you know is interested, please email, or call MR Tate or Sam Skeegan. General Manager. A worldwide leader in manufacturing and marketing of dental, surgical and medical devices needs a leader with experience with manufacturing technologies used in the medical device or pharmaceutical industry. Will direct the operation of a 500 employee optimized manufacturing facility that fosters high quality and must have experience in an FDA-regulated industry (medical device or pharmaceutical) Senior Formulations Scientist Well established manufacturer of biological pharmaceuticals is seeking a Sr. Formulations Scientist to develop formulations that ensure the stability of biological molecules. Will study the chemical stability of proteins in relation to excipient and storage conditions and develop final drug dosage forms. Will develop and characterize stable parenteral formulations for preclinical and early clinical studies as well as writing and reviewing appropriate technical SOPs for use both internal and CMO and/or CROs Communication. Experience in developing formulations of small molecules for parenteral administration in both pre-clinical and clinical studies with good understanding of excipient selection and limitations of use and 5 years of pharmaceutical industry formulations experience in formulation development for both liquid and solid dosage forms is required. PhD Mid-Atlantic $70-90K Sr. Director Engineering & Facilities Expanding global pharmaceutical company wants a Sr. Director Engineering & Facilites to lead all aspects of engineering, utilities, maintenance, facilities services, construction management, facilities planning and capital project management at a new manufacturing site. Need minimum of 10 years experience in a biopharmaceutical environment with at least 5 years in a management role. Experience with cGMP operations in FDA regulated facility required and experience with managing capital projects valued over $5 M. Will write and approve Standard Operating Procedures, work closely with Operations and Quality organizations during design, construction, start-up commissioning/ Director Quality Assurance Expanding pharmaceutical company needs 10-12 years of QA or Compliance experience supporting GMP., GLP, and/or GCP operations in biologics industry. Will direct the Quality compliance requirements and develop and implement Quality Systems and infrastructure appropriate for product development and in compliance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) regulatory requirements. Will manage the Quality Assurance (QA) department to effectively assure quality requirements for the supply and testing of products from pre-clinical testing through BLA submission and monitor compliance for the management and conduct of clinical trials. Requires working knowledge of GMPs, GLPs, GCPs and ICH guidelines and the ability to lead projects with minimal supervision. .Mid-Atlantic $120-150K Project Analyst A rapidly growing, publicly traded, biotech is looking for 3-5 years project management experience to support complex cross-functional project teams working on advancing the Company's products through the stages of product development to licensure and commercialization. Certification in project management (PMP, CAPM) preferred with a general understanding of the pharmaceutical/ Senior Manager Regulatory Affairs Pharmaceutical company wants 5+ years of experience in CMC regulatory affairs, with experience in biological and vaccine products strongly preferred. Will be an integral member of the Regulatory team, providing CMC regulatory strategy development and implementation plans that incorporates risk identification and contingency planning at a licensed manufacturing facility. Will act as the main regulatory affairs contact for facility personnel regarding implications of anticipated changes, such as process scale up, technology transfer and other manufacturing process improvement efforts. Will provide support to QA for Regulatory Agency inspections and participate in communications with FDA or other Regulatory Agencies. Mid-west. Director Validation Expanding biotech validating a new facility would like a minimum of 8 years experience in aseptic pharmaceutical manufacturing, with at least 5 years in a management role. Should also have experience with computerized system validation and Part 11 compliance. Experience with new facility commissioning and validation is critical. Will be responsible for oversight of production, process control, and utility validation activities in support of product manufacturing for both clinical and commercial manufacturing operations. Will direct the Validation unit with regard to ongoing development and implementation of the site Validation Master Plan and, in conjunction with Quality Assurance, maintain the Validation program in compliance with regulatory requirements, industry standards and industry best practices. A working knowledge of SAP and DeltaV is desirable. Mid-Atlantic $130-160K SENIOR MANAGER PROCESS DEVELOPMENT Premier marketer of plant-based health and beauty products seeks a senior manager of process development to provide a high level of engineering expertise. Will innovate, plan, and lead major process projects in all areas of cosmetic manufactureing involving engineering design, development and/or new processes or modification of existing processes. Will work with R&D Director level personnel and Manufacturing/ Director Manufacturing Operations Publicly traded growing biotech wants experience working in a biological vaccine/therapeutic manufacturing environment in a management capacity. Requires knowledge of cGMP and CFR requirements and FDA / CBER experience. Mid-Atlantic $120-165K. Director Regulatory Affairs Growing manufacturer wants 8-15 years of experience in the Regulatory Affairs of biologics to oversee all regulatory activities for the Company's manufacturing facility. Will manage the Regulatory Affairs department to effectively support international licensing activities and oversee implementation of foreign registration requirements. Will plan and execute key regulatory filings in support of various manufacturing changes to enhance cGMP compliance, production capacity and product improvement and serve as regulatory liaison to the FDA and other regulatory authorities for assigned projects. BS in a Biological Science. MS/PhD in a science preferred. Biostatistician Biopharmaceutical company is seeking a manager to lead Statistical Operations for development projects within Clinical Development. Will provide statistical input into clinical development plans, protocols, statistical analysis, clinical study reports, summary documents and clinical parts of Investigational Drug Brochures. BS in Biostatistics with at least 7-10 years experience within a Pharmaceutical company/CRO. Mid-Atlantic $80-110K. Project Manager-Information Technology Projects Pharmaceutical manufacturer needs 5 years experience managing multiple technology application development projects using a software development life cycle. Requires a strong background in using project scheduling tools such as Microsoft Project and experience in biological or pharmaceutical industry. PMI Certification desirable. Must possess strong management, analytical and risk assessment skills, and the ability to manage multiple projects with users at different sites (US and global) Director, Project Management Pharmaceutical/ Engineering Supervisor Pharmaceutical manufacturer wants 5 years experience in the pharmaceutical industry or related technical field and 2-3 years of supervisory experience. Will provide leadership in production/engineer Immunologist Product Development department of a major vaccine manufacturer seeks a Ph.D. in Microbiology, Immunology, Biochemistry, or related discipline and 5 years of relevant experience (preferably industry). Wide knowledge and experience with immunological assays including direct binding ELISA, inhibition ELISA, capture ELISA, antibody neutralization assays, and other cell- based immunoassays is required. Will design and develop novel and critical serological assays, will oversee assay execution by subcontractors performing assays, qualification and validation of serological assays- will conduct analysis of data related to biodefense projects as well as commercial vaccine projects, analysis of animal study data, design of animal studies to evaluate vaccine candidates, review and approval of assay results and study reports, assistance in the preparation of regulatory documents (IND and FDA reports). Experience with ELISpot, immunoblots and cell culture for cell-based assays is desired. In addition, general vaccine development experience from R&D through licensure is desirable. Mid-Atlantic Biochemical Engineer The Technical Transfer & Manufacturing Support Division of a specialty biologicals manufacturer is looking for 3-5 years of experience with a broad knowledge of principles, practices and procedures of biochemical/ Principal Scientist, In-Vivo Testing Growing biotech wants experience in pre-clinical development of biological products, particularly design and execution of animal studies, to support non-clinical development of vaccines and immunotherapeutics. Will be responsible for the design and implementation of non-clinical studies to meet regulatory requirements for biologics and blood products and ensure success of projects through interaction with scientists and CROs. Will also participate in the evaluation of and response to Government RFPs, RFIs, and RFAs in support of new and existing products. Must have strong familiarity with GLP and requirements for demonstration of efficacy using the FDA "Animal Rule". Ph.D. in Microbiology, Immunology, Biochemistry, with 3+ years of post-doctoral training with 2+ years of directly related experience. Mid-Atlantic $70-90K
---------- Forwarded Message ----------
From: "Ravi Chakravarthy" <chakrar@hotmail.
To: "Ravi Chakravarthy" <chakrar@hotmail.
Subject: [CIT_Group] FW: current Rx technical openings 310 ac
Date: Tue, 9 Mar 2010 11:33:05 -0500
Sent: Saturday, March 06, 2010 12:27 PM
To: Sam Skeegan
Subject: current Rx technical openings 310 acScientist -Assay Development
Will provide direction of Manufacturing Assay Development Unit staff in collaboration with process engineers, pharmaceutical chemists to design and conduct of scientific studies necessary to meet specific research project goals. Constructs project timelines, identifies technical or resource issues, and takes remedial action to prevent delays. Prepare reports, proposals, patent application, publications, IND and NDA reports; Maintain regulatory compliance and knowledge of safety, environmental and GMP issues; Lead technology transfer projects from development sites, and to QC laboratories for validation; Lead Troubleshooting and problem-solving investigations; Resolves technical issues and drives the completion of investigations that affect the technical scope; Provides input to the development of internal systems and SOPs to ensure studies are carried out in compliance with current regulations. Masters with 5-10 years, or PhD with 2-5 years of pharmaceutical laboratory experience. .mid-west $70-90K
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