Seeking Entry Level candidates with a Bachelor's Degree in Biology, Chemistry, Microbiology, Biochemistry, or other scientific field, to work as QA Analyst / Consultants for a pharmaceutical client in Fort Worth, TX 76134. Recent graduates are fine.Technical Accountabilities:- Audit product lots- Pull analytical samples- Pull, log and inspect retention samples- Review MBR for release- Review and approve autoclave reports and logbooks- Update databasesEducation/Experience:- B.S. in Science (Chemistry, Biochemistry, Biology, Microbiology, Pharmacy) Demonstrated excellent written/verbal/interpersonal/communication and ability to perform effectively in a fast paced, team oriented environment. Skills:- Good computer skills- Good time management & communication skills- Attention to detail- Ability to multi-task- Fluent in English
Careerbuilder • Fort Worth, U.S.
Location: Bayport, TXThe Chemical Process Engineer – Staff will be responsible for engineering needs demonstrating skills in plant troubleshooting, process design, process control and monitoring, project management and implementation, capital budget developments and management, new technology development and implementation. The Chemical Process Engineer – Staff will be responsible for interfacing with other parts of the organization which include safety, environmental, process safety management, and product quality. Primary ResponsibilitiesConduct process troubleshooting. Identify and implement process improvements;Maintain and improve process control systems;Identify and manage capital and other various projects through completion;Process Safety Management (PSM) - Complete various PSM responsibilities including Management Of Change (MOC) and Standard Operating Procedures (SOPs);Implement safety and environmental improvements; andMonitor and improve product quality. Required Education and ExperienceBS in Chemical Engineering or other Engineering discipline is required;Minimum of five (5) years experience as a process engineer in a chemical manufacturing environment is required;Experience leading cross-functional teams and projects also required;Strong computer skills including Microsoft Office Suite, SAP required;Ability to configure and maintain process control systems such as Delta V and PLCs ( Desired) Experience leading small to medium size capital projects required; and Experience with the following unit operations and equipment (reaction, distillation, heat exchange, pumps, scrubbers, cooling towers) also is required.
Goodyear Tire & Rubber Company • Pasadena, U.S.
Summary of Role\:GlobalFoundries Fab 9, the world leader in RF semiconductor manufacturing in Essex Junction, VT, is seeking an entry level Semiconductor Process Engineer. The individual selected for this position will be part of the Manufacturing Engineering organization with primary responsibilities focused on development, support and continuous improvement of 200mm semiconductor manufacturing processes.Essential Responsibilities include\:Establish and manage the equipment quality control planDrive continuous improvement efforts in support of throughput improvement, cost reduction, and yield learningDefine and maintain equipment installation process qualification roadmaps - Drive process qualifications, implement process control plans and configuration with the area equipment engineers, including qualification, start up and volume ramp of process equipmentDesign, execute, and analyze experiments to screen and optimize manufacturing processes to meet technology (performance, yield, and reliability) and manufacturing (process stability, cost of ownership) targetsMust be technically inclined and able to lead hands on, tactical troubleshooting efforts to resolve long term performance issues; must be able to deconstruct and understand complex systemsCollaborate with GlobalFoundries integration, equipment and quality engineering to support the development of improved next generation technologies.Support technology transfer to other fabricatorsAbility to marry both the equipment and process sides of issues, focusing on delivering the right results on productOther Responsibilities\: Perform all activities in a safe and responsible manner and support all Environmental, Health, Safety & Security requirements and programs.Qualification:Required Qualifications\:Technology related Bachelor’s Degree in Chemical Engineering, Electrical Engineering, Materials Science, Solid State Physics or other relevant disciplineFluent in English10% travel may be requiredPreferred Qualifications\:COOP/Intern in semiconductor or manufacturing industryKnowledge of semiconductor/silicon processingUnderstanding and knowledge of Statistical Process Control (SPC) and Design of Experiments (DOE)Prior experience working in a semiconductor cleanroom environmentTechnology related Master’s and/or PHD degree\: Chemical Engineering, Electrical Engineering, Materials Science, Solid State Physics or other relevant disciplineAbility to work effectively and efficiently with diverse teams, customers, internal and external partners
Careerbuilder • Essex Junction, U.S.
A Pharmaceutical Company is seeking a Research Associate in Frederick, MD. Role Description This role will provide process engineering and analytical support for commercial manufacturing of cell therapy. Working cross functionally with quality, operations, material management, facility and engineering functions, the role is expected to provide technical input for product/process response and investigations, technology implementation, technology transfers, process validation and regulatory filings. • Execute scientific laboratory studies to support process/product understanding and continuous improvement projects • Execute analytical testing of cell therapy products – flow cytometry, ELISA and PCR assays. • Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench • Provide technical input to the execution of process validation and comparability campaigns. • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing • Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation. • Participate and report to a cross-functional team to advance production activities. • Participate in Operational Excellence activities within Tier Structure. • Participate continuous improvement projects supporting commercial manufacturing site • Ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing. • Support technology transfers of launch and commercial cell therapy products • Effectively & efficiently communicate manufacturing process performance internally. • Support the implementation of automation and IT infrastructure projects • Assist in writing technical documentation (protocols & reports for equipment/instrument qualifications, comparability, and cell therapy manufacturing process validation) Skills & Requirements • Bachelors Degree in Biochemical Engineering, Tumor Immunology, Biotechnology or Life Sciences. • Basic understanding in Bioprocessing, Cell Culture and Biochemistry. • Knowledge of ELISA and/or PCR testing • Knowledge in flow cytometry and data analysis (FACSDiva, FlowJo, GraphPad Prism, Excel) is a plus • Ability to think critically, demonstrate troubleshooting and problem-solving skills • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment • Previous experience with other technologies is a plus • Experience with the use of Microsoft word, Excel, Power Point, Smartsheet, Prism, JMP, and other data analysis applications • Highly collaborative with excellent interpersonal, verbal and written communication skills • Ability to think critically with demonstrated problem-solving and troubleshooting skills • Comfortable working in a fast-paced company environment with minimal direction and able to adjust workload/assignments based upon changing priorities • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
HAYS PLC • Frederick, U.S.
An American Company is seeking a Statistician II/III in Gaithersburg, MD. Role Description We are seeking a Statistician II/III to join our Data Science and Statistics team. This position directly supports all our nonclinical groups, and provides guidance in the utilization of appropriate statistical methodology to scientists and management. • Provide sound strategic, scientific, and statistical input to support our nonclinical research and development projects, through design of experiments and by using appropriate statistical methodology and sample size. • Prepare statistical analysis plans; analyze experimental and historical data. • Create design of experiments and perform various types of statistical analyses to develop predictive models and optimize conditions for processes, methods, and drug product/drug substance storage. • Perform stability analysis to identify degradation rates and expiration dates. • Prepare the statistical section of technical reports and presentations. • Engage in discussions and research to ensure the central place of applied statistics in research, development, quality, and validation projects. • Manage one's projects effectively, and meet deadlines with high quality of standards • Explain statistical designs and concepts to non-statisticians • Meet company milestones Skills & Requirements • A degree in Statistics/Biostatistics, Bioengineering, Chemical Engineering, or a related field, with at least 5 year of relevant experience is preferred. • Sound knowledge of theoretical and applied statistics is required, with an emphasis on experimental design in biotechnology, power calculations, survival analysis, etc. • The candidate should have hands-on experience with using and scripting statistical software packages including JMP, SAS, and R. • Familiarity with ICH guidelines • Experience in the drug development field is preferred. • Must be an effective team player, able to thrive in a fast-paced team environment, and also work independently on projects. • Excellent interpersonal, oral, and written communication skills. • Leadership ability to influence team members and communicate statistical concepts across functions.
HAYS PLC • Gaithersburg, U.S.
Our client, one of the largest Contract Development & Manufacturing Organizations (CDMO) in Europe is currently looking for their future Analytical Development Labs Head. Your responsibilities:Based in the Innovation and Development group, you will bring a deep understanding of development and validation of modern analytical methods, with a passion for leading dynamic and high performing teams in an evolving environment (internally, externally). External collaboration with clients and technology partners is an important part of the role.Lead and support a team of technicians and scientists.Maintain an up-to-date understanding of trends, requirements, and regulations in analytical methods.Ensure that a comprehensive analytical platform is in place for all aspects of Safety, Identity, Strength, Purity and Quality.Provide quality, on time, analytics for external client projects in various phases of development (pre-clinical, clinical), and ensure the transferability of methods into QC labs to support clinical and commercial release testing. Your profile:PhD in Life Sciences preferred, with a focus on proteins or biochemistry.Ideally 8+ years of experience in an applied setting, with experience of working in multi-disciplinary teams.Previous experience in management of teams.Strong understanding of biological production processes.Solid understanding of analytical method development and validation (accuracy, precision, robustness, etc), including regulatory expectations (e.g., ICH, EP, etc).Great experience in Project Management.Strong oral and written English skills Business fluent English (B2-C1 level); similar level in French (B1-C2).
Approach People Recruitment • Paris, France
Vos Missions :• Rédiger et exécuter des protocoles d’essais en respectant les standards internes. • Définir et participer aux étapes d’industrialisation et / ou amelioration de procedés de fabrication • Définir la stratégie et exécuter les validations initiales des nouveaux procédés et équipements complexes • Participer au transfert technologique des procédés de fabrication définis et communiqués par les équipes Développement et projets, • Créer ou mettre à jour la documentation projet ou du système du SMQ dans le cadre de son activité en conformités avec les standards internes. • Soutenir les activités de production en prodiguant une expertise pour la résolution de difficultés process Proposer, harmoniser et implémenter les méthodes de travail en vue de cette amélioration • Participer et/ou animer le processus d’analyse de risque, • Participer si nécessaire au processus de déviation, investigation et CAPA • Participation aux validations ou revues périodiques, • Réaliser un reporting régulier de son activité, • Veiller au respect du système Qualité en vigueur, des bonnes pratiques de fabrication, des règles d’hygiène et de sécurité, des règles de fonctionnement de l’entreprise. • Préparer la documentation technique nécessaire pour soutenir un examen des autorités compétentes concernées, en accord avec les normes applicables en vigueurQualifications & Experience• Diplôme d’ingénieur ou équivalent, • Expérience d’au moins 2 ans en R&D ou en Engineering, idéalement acquise dans le domaine de la chimie des polymères, des dispositifs médicaux. en qualification / validation • Connaissances de la norme ISO13485, des BPF et autres normes applicables au dispositif médicaux • Maîtrise des outils informatiques de bureautique standards • Français et anglais courant • Expérience projet en tant qu’acteur ou gestionnaire ayant permis de démontrer une aisance relationnelle, des capacités à dialoguer avec des interlocuteurs variés internes et externes à l’entreprise
Approach People Recruitment • Lausanne, Switzerland
A Pharmaceutical Company is seeking a Lipid Nanoparticle Scientist in San Diego, CA. Role Description The successful candidate will design, manufacture and characterize lipid nanoparticles for the delivery of nucleic acids as well as other novel nanoparticle-based drug delivery formulations containing small molecules, RNA, DNA and proteins. The work is multi-functional and includes formulation design, analytical methods development, physical characterization, experimental design, sample analysis and interpretation of results. The candidate with be expected to bring prior experience in the field and interact closely with other researchers in the design of lipid nanoparticle delivery formulations. This is a hands-on, laboratory-based role in a highly collaborative early development environment. Job Description: • Must have experience with lipid nanoparticle delivery of RNA or DNA for transfection to mammalian cells or in-vivo models. • Must have experience in nanoparticle formulation and nanoparticle drug delivery. • Must have experience in development of methods to analyze and characterize nanoparticle formulations, components and functionality. • Background in the biology of gene transfection and expression is a plus. • Experience and technical proficiency with HPLC and other methods for analysis and quantification of small molecules, DNA and proteins is preferred. • Previous experience and technical proficiency in the physical characterization of nanoparticles, including particle sizing is a plus. • Familiarity with lab-scale nanoparticle preparation techniques, including microfluidics technology, is preferred. • Experience with alternate pharmaceutical manufacturing technologies homogenization, lyophilization, micronization, etc. is a plus. • Strong interpersonal, communication, collaboration and problem solving skills. • Ability to document work and proven record of scientific technical writing. Skills & Requirements • Qualifications: Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Biomedical Engineering or closely-related discipline with an emphasis in delivery of nucleic acids. M.S. or B.S. in similar fields acceptable with a minimum of 6+ years of relevant industrial experience.
HAYS PLC • San Diego, U.S.