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Seeking a protein purification expert to lead the development, optimization, scale up and technical transfer of all downstream process into clinical and commercial manufacturing Requires: Experience scaling up and transferring purification processes for proteins, enzymes, PEGylated proteins, antibodies, into clinical or commercial manufacturing High visibility management grooming position with up and coming international biologics company includes extensive perquisites, company equity, ...

JOB SUMMARY: Qualified candidates must be experienced QA professionals proficient in providing leadership in Batch Record Release and disposition of in-process commodities and final products for all site-manufactured products. Through subordinate staff this person will assure that each batch released has been produced, tested and verified to be in full compliance with product specifications, GMP regulations and release requirements. This person will also lead the site Statistical Process Control ...

Novartis Pharmaceuticals Description: Under general supervision, in collaboration with supervisor and project teams, lead the formulation development activities for peptides and therapeutic proteins. Design and perform studies to assess the physical stability of proteins using particle aggregation analysis techniques, such as dynamic light scattering and micro flow imaging, and analyze the chemical stability of proteins by ion-exchange and size exclusion chromatography. Design experiments to ...

$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 ...

Novartis Pharmaceuticals Description: Scientific, strategic, and operational leadership and management of a therapeutic area (TA) in support of all projects in the TA, to drive implementation of innovative confirmatory study designs and analyses; to advance the pipeline through contributions of high quality, effective, and impactful work products; and to lead and coach trial statisticians who support the projects in TA. Scientific, strategic, technical, and operational leadership and management of ...

Description: • Responsible for ensuring regulatory compliance with safety surveillance activities for assigned products • Processes case files in accordance with regulatory requirements and Quality Module 3.8 • Point of first contact for medical safety information from surgeons, other medical professionals and consumers • Reviews and assesses designated quality complaints and adverse events for reporting requirements • Using clinical judgment, documents and classifies as reported events according to ...

Responsibilities: • Under supervision, writes Validation protocols for moist heat and dry heat sterilization • Executes, analyzes data and compiles final report • Cross train to do the same for sterile filtration; gamma sterilization • Mixing; and cleaning validations. Requirements: • Microsoft Excel, Word, Powerpoint • Strong Verbal and Written communication skills • Time Management Education: • BS Engineering, Chemistry, Biology • Strong Physics background NO relocation, NO sponsorship. US based ...

Responsibilities: • This position will assist Molding Engineers in the setup, operation and product packaging of an injection molding machine producing plastic parts. Requirements: • General Laboratory experience is preferred. • Injection Molding experience preferred Education: • B.S degree in Chemistry, Biochemistry, Microbiology, Biology, Biomedical Science/Engineering or 5 years of work experience. NO relocation, NO sponsorship. US based candidates only, please

Responsibilities: • Provide medical review of draft and final advertising and promotional materials (eg, print, presentation, and web materials) used by client to promote its products to consumers or health care professionals. • Assure compliance of promotional and advertising materials with approved labeling, and with applicable FDA, FTC, and state regulations Requirements: • Knowledge of ophthalmic pharmaceutical products, detail-oriented, ability to review literature and other scientific ...

Responsibilities: • Responsible for review and closure of product quality complaints and medical reports for client’s products. • Ensures individual case report files are complete, all documents are properly attached and meet the criteria for closure. • Major Accountabilities include: review and closure of pharmaceutical complaint files Responsibilities: • Advanced Computer skills • Detail oriented • Organizational skills a must • Ability to Multi-task Education: • AS/BS degree • Medical experience ...

Responsibilities: • Develop validation protocols, review user, functional and regulatory requirements, develop test plan traceability matrix, develop PQ Test protocols and prepare summary report. • Validation of equipment and processes associated with product manufacturing the in the Fort Worth Facility. • The primary focus will be on cleaning validation, mixing validation, bulk product hold times, etc. Requirements: • Proficient at MS Word and Excel. • Strong Technical Writing Skills • Ability to ...

Responsibilities: • Support deliverables needed for Elemental Impurities project. • Deliverables include method development and method validation for testing of raw materials and finished products for metals content by ICP-MS instrumentation. • Routine sample analysis using the ICP-MS instrumentation and related equipment for sample preparation. Instrument and equipment qualification and development of instrument operating procedures. • Routine preventative maintenance and calibration of ...

Responsibilities: • Perform microbiological environmental monitoring of fill rooms, ancillary room and compounding areas. • This will include utilities (compressed air, water and steam), air sampling (viable and non-viable), surface sampling and personnel sampling. Requirements: • BS degree in Biology or Microbiology • Microsoft Word, Excel • Ability to lift up to 25 pounds and stand on feet for long periods of time. • Ability to be gowned up including hood and mask for up to 2 to 3 hours at a ...

Responsibilities: • Analyzes chemical, biological or microbiological products, raw materials, in-process materials, or stability samples in support of the company's quality program. • Interprets and evaluates the analyses in terms of accuracy and precision and recommends corrective action where necessary. • Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devises and develops new analytical methods and ...

Hello, My name is George Rogers and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Regulatory Compliance position for a prominent client of ours. This position is located in Fort Worth, TX. Details for this position: Will be required to perform statistical analysis of trending data. Must be able to summarize technical data for formal protocols. Candidate will write and review regulatory compliance related documentation. Will be required to perform ...

Hello,   My name is Phil and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a  Validation Engineer for a prominent client of ours.  This position is located in Fort Worth, TX. Details for the positions are as follows:   Validation Engineer Duties:  ·         Develop validation protocols, review user, functional and regulatory requirements, develop test plan traceability matrix, develop PQ Test protocols and prepare summary report. Skills:     ·         ...

Duties:Must be able to work independently to perform business analysis activities towards goals of a program of information/data governance/security/compliance-related projects and initiatives. Must be able to independently and effectively engage in all typical project functions including but not limited to: Schedule/Time Management Status Reporting Issue Management Risk Management Documentation Management Requirements Management   Generally has 7-9 years experience Skills Must have a minimum of 7 ...

  Duties Manages one or more non-technical projects within the constraints of scope, quality, time, and cost, to deliver specified requirements. Responsibilities may include resource allocation and all phases of development life cycle (i.e. feasibility study, requirements, analysis, ROI, business plan, design testing, and implementation planning). Regularly interacts with management. Coordinates and directs the activities of project team members. Ensures all project requirements and/or objectives ...

This is a home based permanent position. Must have strong experience in Solid Tumor Oncology. 2 years of Monitoring experience required: 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 regulatory requirements,  Standard Operating Procedures (SOPs), Standard ...

Responsibilities: • Must be able to work independently to perform business analysis activities towards goals of a program of information/data governance/security/compliance-related projects and initiatives. • Must be able to independently and effectively engage in all typical project functions including but not limited to: o Schedule/Time Management o Status Reporting o Issue Management o Risk Management o ...

Responsibilities: - Responsible for review and closure of product quality complaints and medical reports for Pharmaceutical products. - Ensures individual case report files are complete, all documents are properly attached and meet the criteria for closure. - Major Accountabilities include: review and closure of pharmaceutical complaint files Requirements: - Associates degree required, Bachelors degree preferred - Detail oriented - Organizational skills a must - Advanced computer ...

  Duties Responsible for review and closure of product quality complaints and medical reports for Pharmaceutical products. Ensures individual case report files are complete, all documents are properly attached and meet the criteria for closure. Major Accountabilities include: review and closure of pharmaceutical complaint files Skills Advanced Computer skills Detail oriented Organizational skills a must Ability to Multi-task   Education Fluency in English essential associates degree or ...

 Come work for a well known CRO in TX.  They are seeking RCRA's who have 2+ years of on-site monitoring experience in any therapeutic area.  Attractive compensation and benefits.

 Hello,   My name is Phil and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a  IGM Business Analyst for a prominent client of ours.  This position is located in Fort Worth, TX. Details for the positions are as follows:   Duties: ·         Must be able to work independently to perform business analysis activities towards goals of a program of information/data governance/security/compliance-related projects and initiatives. ·         Must be able to ...

Job Overview Apex is an environmental consulting firm that offers stable leadership and growth, views employees as valuable resources, and rewards success with competitive pay and bonuses. We are seeking a self-motivated Water/Wastewater Project Engineer to join our team in Frisco, TX and become an integral part of our continued success story. Responsibilities This position entails engineering design, process control, regulatory permitting, operations planning, project scheduling, project ...

Contract opportunity with our client in Fort Worth, TX. Duties: Support deliverables needed for Elemental Impurities project. Deliverables include method development and method validation for testing of raw materials and finished products for metals content by ICP-MS instrumentation. Routine sample analysis using the ICP-MS instrumentation and related equipment for sample preparation. Instrument and equipment qualification and development of instrument operating procedures. Routine preventative ...

  Perform business requirement analysis, system design, configuration, development, validation testing and system administration tasks for  Quality Systems such as Corrective and Preventive Action, Plant Change Management, and. Complaints Management. Perform daily administrative related to technical and functional support of Trackwise application, including user interaction. Adhere to and proactively address all compliance processes and procedure related to GxP systems Document process and ...

 Duties Project and Service Quality Manager. Quality Assurance Process and project Review, focusing on Service Desk, Documentation review, review and develop test scripts, quality plan, quality report, test remediation, CFR 11 validation expertise; 3-5 years experience. Skills Microsoft Office expert level, Validated environment experience   Education Bachelors or equivalent experience

    Responsibilities: Responds to adverse event and quality reports received from external customer groups - healthcare professionals, patients, caregivers, the general public and ensuring prompt, accurate, quality assured documentation and responses. Addresses and expedites product complaints under the company's complaint policy and procedures, and ensures compliance with federal regulations. ...

  Duties Injection Molding Technician. This position will assist Molding Engineers in the setup, operation and product packaging of an injection molding machine producing plastic parts. Skills General Laboratory exerpience is preferred. Injection Molding experience would be ideal.   Education B.S degree in Chemistry, Biochemistry, Microbiology, Biology, Biomedical Science/Engineering or 5 years of work experience.  

Opportunity for a senior level scientific strategist to lead and influence translational science teams, biology groups, clinical pharmacologists, biomarker discovery efforts, early phase clinical trial design and therapeutic development strategies for the creation of novel oncology drugs. Shall: *** Interact and establish relationships with KOL's throughout the world of Oncology *** Serve as a liaison for clinical development to promote seamless transition between research and development *** ...

 They are requiring candidates to have the following experience:  1+ Years MSL experience is a must Strong Science Background Preferred Hospital setting experience is required 5 years of experience (hospital experience in cath lab, special procedures, endoscopy, bronchoscopy suite) Experience with Infusion drugs is a plus Oncology experience is a plus Degree: RNs, PAs and Nurse Practitioners or PharmD, PhD

Exciting MSL opportunity based out of Baltimore, Philadelphia, D.C, Dallas or Houston Must have a science background 1+ years of MSL experience Must have a MD, PhD or Pharm D.

Perform microbiological environmental monitoring of fill rooms, ancillary room and compounding areas. This will include utilites (compressed air, water and steam), air sampling (viable and non-viable), surface sampling and personnel sampling. This position will require company uniform, steal toed shoes and a garbing qualification to enter controlled areas. No make-up or jewelry allowed. Group setting with approximately 5 other analysts. Overtime and weekend work may be required. Skills word, excel, ...

Contact Kristine at 815-756-1221 for more details. Qualifications: - MS/PhD Food Science - 5+ years of research and product development experience in a food or ingredient company - Project management skills - Excellent communication and leadership skills - Able to travel 15% - Strong working knowledge of ingredient functionality and product formulation - Familiar with turning business needs into technical decisions Responsibilities: - Will support market objectives by creating new opportunities for ...

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 ...

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 ...

Contact Crystal at 815.756.1221 for more details. These positions will be responsible for scale-up, formulation, management of technicians, customer presentations, data record keeping, and customer technical service. Qualifications: - BS Chemistry, Biology - 5+ years of coatings development - Experience with 2k, thermoset, and air-dry coatings technologies - Project management skills - Customer presentation experience - Excellent communication skills - Minimal travel required, 10%

Job Title: Global Trade Compliance Governance Posting Type: Contingency # of Positions to Fill: 1 Location Country: Americas City: Dallas, TX Functions Executive / General Management Industries Chemicals / Plastics / Composites Other factors Will Relocate Interview Travel Reimbursed Detailed Description Purpose and Summary of position: The Global Trade Compliance Governance Manager will have primary responsibility to ensure adherence to our global trade compliance policies and ...

HISTOLOGY SUPERVISOR Responsible for competency, evaluations, hiring, disciplinary actions, and continued education of histology related personnel. Responsible for suggesting terms of employment, contract negotiation (contract employees), and following the processes of rehabilitation and disciplinary actions of lab related employees. Acts as liaison between histology personnel and Laboratory Manager. To perform this job successfully, an individual must be able to perform each essential duty ...

Contact Kimberly for details: 815-756-1221 The Chemist will be responsible for formulating silicone and other elastomers for R&D activities. Will develop new products and be a technical support as needed to customers. Qualifications: - BS-PhD Chemist - 2+ years in silicone elastomers applications or coatings formulation - Experience with LDR, HCR, RTV and HTV systems - Assertive

Select Staff is seeking a dynamic Microbiologist to join a team of dedicated professionals focused on client service and quality. The ideal candidate will be motivated, energetic, forward thinking, and possess outstanding technical skills. Company is located in South Dallas. Manage all micro documentation Track, trend, and investigate of all factory consumer complaints. Become a link between hygiene (micro) and complaint investigation / education Trouble shoot, track and trend micro data. ...

Seeking 5+ years experience in biological manufacturing in a quality assurance function with track record designing, planning and conducting live training classes to administer Learning Management System, maintain training metrics, assign curricula, conduct curricula maintenance, facilitate timely completion of site training requirements, identify training needs, and perform GMP training. Diverse career path choice and generous benefits package including 401(k) plan which matches, medical, dental, ...

This person will oversee a staff of seven chemists for testing and analysis of chemical, biological and microbiological products, raw materials, in-process materials and stability samples in support of sterile drug product processing and manufacture. Specific areas of expertise needed to be successful in this position include analytical methods development (HPLC, GC, etc.) and validation, sterile/aseptic product experience a BS degree minimum in Chemistry required and at least six years drug industry ...

This person will be resonsible for a wide range of validation projects for one of the world's leading sterile drug firms to include Cleaning, Sterilization (Steam/Autoclave and EtO), HEPA filtration systems, water to include RO, DI, WFI, SIP, CIP, process validation and other areas. Qualified candidates must have four or more years of aseptic process validation experience, a BS degree minimum in an Engineering or Scientific discipline, and an ability to manage multiple projects simultaneously. This ...