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Description The Analytical Support Associate will support document creation and review related to analytical methods, deviation reports and change controls generated in the Manufacturing Science and Technology (MS&T) and Quality Control analytical laboratories. Responsibilities: • Review and approve various documents from the Quality Control Department related to method SOPs, method qualification and validation • Support deviations, change controls and corrective actions involving MS&T analytical ...

Hands on team leadership opportunity to develop protein purification and characterization processes to support biologics manufacturing of Monoclonal Antibodies, Enzymes, Growth Factors, PEGylated Proteins and Cytokines derived from mammalian cell lines Will: *** Develop new purification procedures to be transferred and scale up to clinical and commercial manufacturing *** Evaluate transferred processes, validate existing procedures, ensure viral validation, and train manufacturing team on new ...

  *Please Note: Candidates cannot begin an assignment without a completed and successful drug/ background screening. *7 month contract assignment in Durham, NC Under the direction of GMPQ supervision, the Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs)And other applicable worldwide ...

For full details/contact me at [email removed] Highly Competitive Base and Bonus/stock option Plan -Full relocation   Description: To lead the electrical engineering efforts within product development Duties: • Electrical technical lead for R&D product development team to develop the electronics and control systems within reusable and disposable medical systems. • Responsible for the development of the electronic system architecture and ...

Seeking 3+ years experience developing and validating analytical methods in support of the development of manufacturable pharmaceutical products. Candidate must possess: *** Experience in API characterization. *** Hands-on use of HPLC, GC, particle size, dissolution, droplet size, AA, DSC-TGA, DVS, MS, XRD, and NIR. *** Previous exposure to analyzing inhaled, nasal, topical, transdermal, oral, parenteral, and novel dosage forms. *** Familiarity with cGMP guidelines and analytical regulatory ...

Responsibilities: **This is position requires frequent 3pm - 11pm shift coverage. The employee will primarily work M-F, 8am - 5pm, but must have the ability to cover 3pm - 11pm for weeks at a time. Please make sure candidates have this availability!** • Perform batch record review concurrent to completion of manufacturing operations in real time. • Perform routine quality audits in Manufacturing. • Support quality systems related to QA for in-process sampling and controls, and all aspects of shop ...

The successful candidate will provide timely data collection and analysis support for the flu cell culture (FCC) manufacturing process. Routine job responsibilities are to: • Collect and compile electronic and paper-based process data. • Analyze process data using graphical and numerical methodologies. • Generate figures and summary tables of process data for routine monitoring and reporting. • Contribute to the preparation of technical reports on process performance. • Contribute to deviation ...

Description: Support organization and start-up of the QC Raw materials laboratory. Execute method validation and transfers for assigned raw material assays. Strong knowledge of FTIR required. Assist with transfer of analytical methods into the QC Raw Material lab and ensure that the transfer activities stay within defined schedule. Ensure that the samples are tested according to quality requirements defined via registered specifications in accordance with local/international regulations. Ensure ...

Responsibilities: • Supports the implementation of necessary Novartis V&D Quality processes, systems, and procedures regarding self-inspections and general compliance at Holly Springs, N.C. • Act as lead auditor during self-inspections (including all prep, day of and follow up activities • Complete general compliance activities including but not limited to regulatory gap assessments and SOP revisions • Reports monthly KPI/KQI’s for self-inspections. Requirements: • Must have experience leading, ...

 Contact me for confidential job description [email removed]   • Mentor and provide technical guidance to the engineering staff • Continue to refine our mechanical development process. • Generate ideas and solutions for new products as well as engineering support for current products. • Comply with regulatory requirements, including company design control procedures. • Review and analyze, including formal reports when necessary, such things as product concepts and needs, ...

  Biotech Greenhouse Associate Specialist Status:Temporary/Contract based in North Carolina Department: Operations     Under the supervision of the Greenhouse Supervisor or the Senior Specialist, the candidate will be part of a team that will be responsible for the seeding, maintenance, propagation and transfections of plants in a state of the art greenhouse. He or she will also provide critical support in the operation and maintenance of the greenhouse. The candidate will be responsible for ...

ProPharma Group is an industry leader providing validation, compliance and technical services to the pharmaceutical, biotechnology, medical device and related industries. We offer the excitement of a consistently evolving career. Our team is continually learning and working on new and exciting projects in a variety of regions. We look for people who excel in their technical area of expertise, believe in our values of Experience, Integrity and Commitment and thrive in the collaborative, ...

The Surgical Sales Representative would be responsible for selling surgical products in accordance with budgeted objectives and to obtain maximum profitability and volume in relation to pre-set standards Responsibilities include: - Educate and inform doctors, nurses, and appropriate staff personnel as to the proper use and maintenance of company products - May direct product evaluations in OR and office settings - May assist in the preparation and operation of trade shows, conventions, and/or ...

Please read the entire job description and if qualified, send most current resume in a Word document to: [email removed] Job Description & Responsibilities The Manufacturing Science and Technology (MS&T) group currently has a position open in the flu cell culture (FCC) technology lab. The successful candidate will perform daily laboratory operations including: • § Execution of laboratory purification process unit operations (ultra-filtration/dia-filtration, gradient ultra-centrifugation, ...

Please read the entire job description and if qualified, send your most current resume in a Word document to: [email removed] DUTIES: • Supports the implementation of necessary Novartis V&D Quality processes, systems, and procedures regarding self-inspection management at Holly Springs, N.C. • Ensures preparation, update and implementation of relevant SOPs. • Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that ...

Please read entire job description and send resume in a Word document to: [email removed] DUTIES: The Manufacturing Sciences and Technology (MS&T) group at the Vaccines and Diagnostics facility in Holly Springs, NC, has an open position for a process support analyst or engineer. The successful candidate will provide timely data collection and analysis support for the flu cell culture (FCC) manufacturing process. Routine job responsibilities are to: • Collect and compile electronic and paper-based ...

our client in RTP, NC is looking for a Scientist with a statistical background using softmax, jmp, and PLA tools. This is a long term consulting position. If interested, please apply to this ad or send your resume and contact details with the job # and job title in the subject line to [email removed] The Analytical Technology group in RTP, NC has an opportunity for Scientist II with a technical background in analytical method validation and proven project leadership. The Analytical Technology ...