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Hello,   My name is Bryson Jackson and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a LIMS Support Administrator for a prominent client of ours.  This position is located in Holly Springs, NC. Details for the positions are as follows:   Job Description:   Duties              Experienced LIMS admin to: Help Configure Labware LIMS for Holly Springs using a new global LIMS system (e.g. Analysis, Standards and Reagents, Batch manager, folders, Lot manager). ...

RESPONSIBILITIES: • Perform timely data review with a high focus on data quality and integrity to ensure accuracy, completeness, cGMP compliance, and neatness of analytical documentation and real time documentation in a GMP environment • Reviews executed protocols for accuracy, completeness, cGMP compliance, and neatness of analytical documentation • Verify calculations and documented information such as reagent expiry, reference standard tracking, instrument calibration, logbook entries, control ...

Responsibilities • Support functions of the Divisional Compliance and Auditing group as assigned, including, one or more of the following: • Act as Administrative Quality Assurance Responsible Person (QAPR) for audits – as directed. • Gather CAPA plans from audit targets • Coordinate review an acceptance of CAPA plan with Lead Auditor and Follow Up Responsible Person (FURP) Enter acceptable CAPA plans in the AQWA database • Assist consultants with travel arrangements Create eReqs, manage ...

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 ...

Seeking a protein expert to lead a team focusing on the development of methods for characterizing proteins and protein based therapeutics. Shall be responsible for hands on method development and team leadership as well as IND and BLA contributions. Requires PhD and hands on development experience with Liquid chromatography - Mass Spectrometry and two dimensional Gel Electrophoresis for characterizing proteins Highly visible associate director level position with a leader in the scientific ...

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 ...

Looking for a qualified SAS Programmer (home based) Requirements include but are not limited to the following: BA/BS degree in computer science, statistics, biostatistics, mathematics or related field. MA/MS degree is desirable  5+ years of programming and clinical research or related experience Must have database management, SAS or PL/SQL programming experience Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills ...

  *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 ...

$5000 Hiring Incentive for Qualified Candidates! Covance is seeking Clinical Research Associates / CRA / Monitors with cardiovascular / coronary artery disease therapeutic experience for a special hypercholesterolaemia project.   Positions are home-based and urgently needed in the following locations:  Raleigh, Dallas, Boston, Chicago, Minneapolis, NYC, Florida, and California.   Our Clinical Research Associates /CRAs / Monitors manage all aspects of site monitoring responsibilities for ...

The Scientific Director provides scientific direction internally to writing staff and account team and externally to clients and authors. Responsible for quality control of medical communication projects through peer review and final sign off. Also will provide writing support for medical communication projects and new business support as needed. Involved in management of writing staff and personnel-related issues.  Excellent salary.  Relocation assistance offered. Education and Core Competencies: • ...

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 ...

Seeking MS and 3+ years experience in analytical methods development and validation to support preformulation, formulation, and product development. Must be familiar with: *** Analysis of novel dosage forms *** High Performance Liquid Chromatography (HPLC) *** Gas Chromatography (GC) *** Liquid Chromatography-Mass Spectrometry (LC-MS) *** Microelectrophoresis Join a passionate and talented team in a rapidly growing company while earning a competitive salary plus bonuses and excellent ...

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 ...

Summary: To support functions of the Sample Management group as assigned. *Assist in response to BAS alarms and documentation in AIM's system, including root cause determination and resolution* Assist with all QCSM equipment PM's* Planning, scheduling, and distribution of all samples destined for various QC labs on 24/7 basis (Bulk, CV, FIO, Fill Finish, M356, MF59, EM/UM, TD Special projects, etc). Total QCSM throughput averages over 450 samples per month and is forecasted to increase with Bulk, ...

Description This position will support the organization of the QC Biochemistry laboratory at the Flu Cell Culture facility in Holly Springs, NC. Primary responsibilities for this position include GMP testing support for biochemistry assays (SDS-PAGE, Threshold, SRD and UV/Vis spectrometry), stability testing, laboratory data review and some participation in method validation and transfer. The QC Analyst I may be identified as a Subject Matter Expert (SME) for biochemistry assays within the ...

Description This position will support the organization of the QC Biochemistry laboratory at the Flu Cell Culture facility in Holly Springs, NC. Primary responsibilities for this position include method validation and transfer for biochemistry assays (SDS-PAGE, Threshold, SRD, and UV/Vis spectrometry). Responsibilities: Primary Functions: • • Subject Matter Expert for biochemistry assays (SDS-PAGE, Threshold, and UV/Vis spectrometry) • • Author SOPs, protocols and technical reports ...

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, ...

Description • To provide detailed QC plan to support SAP production plans and MRP requirements for a production or quality segment, and then to ensure QC control within segment on daily and weekly basis. Responsibilities: These roles will cover QC/QA (Primary and Secondary). • The role is a member of the site Supply Chain Team, working together with other site supply chain functions (Site Product Planners, Schedulers, Artwork and Data Controllers) and specific cross-functional segment team. o Works ...

Associate Director of Regulatory Affairs Global leader in the development and production of life saving pharmaceuticals seeks an Associate Director of Regulatory Affairs to lead regulatory activities in the development of pipeline products as well as the maintenance of marketed products.  The Associate Director of Regulatory Affairs will: Lead regulatory strategies for early to late development of commercial products with a goal of obtaining favorable outcome Provide leadership to project teams ...

Clinical Data Project Manager - Group Leader Highly regarded, global pharmaceutical leader seeks a Clinical Data Project Manager to lead multiple clinical data management teams supporting clinical protocols, data analysis ensuring compliance with regulatory requirements.  The Clinical Data Project Manager will also: Lead clinical data project teams in the design and development of databases, applications and documentation to meet requirements for collection, archiving and documentation ...

 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, ...

Lead the development of preclinical and clinical strategies based on the discovery of molecular biomarkers to drive the creation of novel oncology therapeutics Shall: *** Prioritize and evaluate predictive biomarkers and companion diagnostics to optimize clinical development *** Collaborate with scientific experts to establish accurate and reliable criteria for proof of mechanism and integrate study results into the clinical development strategy *** Determine the role of predictive biomarkers ...

  We are looking for Sr. level candidates, this role can be remote or onsite based on experience.  Relocation is available!   Summary of role Oversee statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians Function as Biostatistics Project Leader for multiple protocols, projects, or NDA projects, including coordinating with other  divisions and ...

 My name is Erica and I represent The Fountain Group.  We are a national staffing firm and are currently seeking someone for a QC Analyst position with a prominent Fortune 500 client of ours.  The position is located in Holly Springs, NC.  If the position sounds like it may be of interest to you, please respond with an updated resume and acceptable salary range.    Job Description: ·         This position will support the organization of the QC Biochemistry laboratory ·         Primary ...

Seeking 3+ years experience developing powdered dosage and particle dosage forms. Shall *** Conduct physico-chemical characterization of drug substances, excipients and dosage forms. *** Apply techniques such as cascade impaction, moisture sorption isotherm, bulk density, surface area, particle size analysis. *** Support scale-up, tech transfer, and process optimization. *** Contribute to regulatory submissions We offer a competitive salary, growth potential and an excellent benefits ...

This is a permanent position. Must have strong experience in Solid Tumor and/or Oncology. Minimum of 2 years of Monitoring experience Regional Travel: Regionalized, may on occassion be outside of region. Job Key Duties and Responsibilities: This position is responsible for performing any/all of the following tasks and responsibilities, as well as any other tasks deemed appropriate by the Supervisor: Monitor activities at assigned clinical study sites to assure adherence to ICH GCPs, local ...

Lead teams focused on developing and optimizing the clinical development for novel oncology therapeutics through the use of predictive biomarkers and companion diagnostics. Shall: *** Provide clinical and scientific input into Discovery Research and Early Development activities, including disease education, target identification, lead selection, preclinical pharmacology POC, nonclinical toxicology, biomarker strategy and IND enabling studies, to develop optimal translational medicine approaches ...

 My client is a profitable public Pharmaceutical company in RTP, NC   Senior Manager, Digital Marketing -- New position based on major growth!   You will be the key person for developing digital marketing strategies for branded, non-branded, and corporate strategic imperatives. This position will manage the execution of digital marketing programs, all marketing-related technologies and will help drive how the corporation leverages online marketing assets.     Additionally, the selected individual ...

Title: Clinical Operations Lead--Work From Anywhere Company: Pharmaceutical Company Location: Midwest Status: Full-time consulting engagement, 40 hours/week Length: Long-term assignment: initial term 6 months Our client is a multinational pharmaceutical company, headquartered in the US, whose goal is to ensure that people everywhere have access to innovative treatments and quality health care. Through working in partnership with everyone from patients to health care providers and managed care ...

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, ...

 Clinical Operations Leader Responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor to ensure that the Global Research Operations deliverables (timeline, quality, productivity) are met. The ClinicalOperations Leader has overall accountability for the execution of the clinical operations strategy on the project. May act as Project Leader for projects involving a small number of services, where no Project ...

Summary:  Responsible for directing regulatory / registration activities for designated US EPA products.  Providing advice and support on technical matters (i.e. crop science, product chemistry, toxicology, environmental fate, and or ecological effects).  Develops and manages product registration and regulatory requirements successfully.  Interacts with internal and external partners; providing strategic regulatory guidance.   Essential Duties and Responsibilities include the following.  Other ...

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 ...

Title of Position:  Manager/Physician SERM (Safety Evaluation and Risk Management) Location: City/State: RTP, NC Zip Code: 27709 # of positions:  1 Contract Length:  18M    Required: Medical degree Advanced evaluation skills and analytical thinking for scientific literature review, data gathering, data synthesis, analysis and interpretation Strong medical/scientific writing skills Sound computing skills In depth knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM ...

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 ...

Process Associate | Lab Assistant Long-term contract Durham, NC [email removed] | 646.790.8355 Perform the emptying, gathering, washing, and restocking of QC lab glassware to storage. Operate Steris and Miele lab glassware washers. Restock QC lab supplies. Require experience and proficiency with MS Word, Excel, and PowerPoint. Must work efficiently and within established time frames and effectively function within a team environment. Excellent communication and follow-through skills required. ...

Seeking Medical Doctor with solid track record in clinical research and clinical trial design in person with: sound scientific and clinical judgment; knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines; ability to effectively present ideas and document complex concepts in written and oral communication; experience providing expert support in a complex matrix environment; and ability to manage multiple projects. Shall: *** Provide planning and oversight to clinical trials. ...

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 ...

Do you have experience building and maintaining web applications using cutting-edge technologies like HTML5, jQuery, AJAX and object-oriented PHP? If so, 3-C Institute for Social Development wants to hear from you! We currently have two openings for web developers and are looking for a developer like you to help build a next-generation application for managing behavioral research projects. If you’re the right candidate for this mid-level position, you have experience with: Working on a team ...

Job Title:  Sr. Regulatory Medical Writer (Multiple Openings) Location:   East Coast Region – Home-based Assignment Duration:  Long-term W2 Contract Job Description: Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common ...

Our client is a dynamic biotechnology company offering an exceptional work environment as well as career opportunities. The Commercial Compliance Manager will be responsible for planning and conducting monitoring activities to ensure sales and marketing actions on behalf of the company are in accordance with laws, regulations and internal company policies. Responsibilities: Develops annual plans, conducts compliance audits and monitors activities based on risk assessments, results of current ...

Regional CRA At Workforce Integration - Wi? - we know people are the key to successful organizations. So we have concentrated on getting people down to a Science. Ask us Wi? Our client is seeking several Regional CRA’s to be based in the SouthEast, within 1 hour of a major airport. These are home based roles and critical to the company's continued success. Role & Responsibility: The selected incumbent will identify, select, initiate and close out appropriate investigational sites for ...