Conduct advanced analytical analysis of starting materials, in-process materials, and finished materials following established procedures and protocols. Perform material analysis by utilizing chromatographic method development and execution.
Major Accountabilities:
Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation.
Use proper scientific tools to accurately analyze and trend data, where applicable.
Clearly and accurately records data and conclusions in laboratory notebook.
Prepares technical documents, including reports and procedures.
Communicates and collaborates routinely with colleagues within the function and sometimes within the sub-team. Functionally communicates with supervisor and mentor. Participate constructively in functional teams and at lab meetings, and offers assistance to co-workers.
General upkeep of laboratory, including equipment/ instrumentation.
Revise and author procedures and technical reports as needed.
Skills:
Quality – No critical audit observations.
Quality – Formal CAPAs and deviations not more than 30 days past due.
Timeliness – On time delivery of data in a suitable format (laboratory notebook, LIMS, technical report).
Throughput – Capable of managing several routine tasks at one time.
Adherence to *** standards and governing procedures and processes, in particular, quality, ethical, health, safety, and HSE standards.
Chromatography and Empower software
Education:
BS degree in Scientific discipline with 3 years of related experience;
MS degree in related scientific discipline with <3 years
Source: Job Diva – Job Listing
We are seeking a motivated and creative Researcher to join the Discovery Sciences group, reporting to a Scientist, to develop Client cell based assays for screening to advance projects to find therapies for neurodegenerative diseases, such as Alzheimer’s disease. The successful candidate will have significant experience in designing and performing experiments in cell based neuro-immunological and signaling assays. The position requires an enthusiastic person with the ability to work in a collaborative matrixed environment to positively impact the progress of projects. The candidate will progressively become independent and learn to develop or adapt new assays and technologies. Candidate is expected to plan, execute, analyze, and record experiments in a timely manner.
Basic Qualifications:
Master’s degree and 5 years of cell and molecular biology experience
OR
Bachelor’s degree and 8 years of cell and molecular biology experience
Preferred Qualifications:
• A B.S. with a minimum of 8 years of experience, or an M.S. with a minimum of 5 years of academic/industrial experience with strong scientific knowledge and research experience in cellular and molecular biology is required.
• Demonstrated independence in experimental design, execution, data analysis, and troubleshooting is necessary.
• Hands on experience with a wide range of in-vitro cellular and biochemical assays, including maintenance of variety of mammalian cell lines, generation of stable cell lines expressing target proteins, electroporation, transfections, western blotting, immunoprecipitation, Flow cytometry, microscopy (immunofluorescence), ELISAs (MSD), luciferase (firefly/renilla) reporter assays, siRNA/shRNA knockdown, CRISPR-mediated genome editing, RT-qPCR, lentivirus generation, and transduction is required.
• Prior experience in development of cell based assays for small molecule compound and/or antibody screening is required, including the high-to-low throughput methods, proof of concept assays, reporter assays are required.
• Eager to adapt and learn new methods and technologies is required
• Proficiency in using software packages such as Graph Pad, Microsoft office etc. for data analysis and figure generation is required.
• Attention to details, excellent organizational, and record keeping skills is a requirement.
• Excellent interpersonal skills with the ability to interact effectively with people, internally and externally is required.
• Background in microglial biology is preferred.
Source: Job Diva – Job Listing
Researcher, Discovery Sciences
The Researcher will contribute to the efforts of the Discovery Sciences team by developing assays for compound screening. This person will work under the supervision of a senior scientist and will be expected to work with increased independence over time. Responsibilities include developing and maintaining cell and tissue cultures, planning, executing, analyzing, and recording experiments using a variety of techniques. The candidate will show a willingness to learn and to adapt to new technologies as needed. We seek a creative, self-motivated, critical thinker who can thrive in a collaborative environment.
Qualifications:
– BS or MS in biology, pharmacology, cell biology, neuroscience, immunology or related field.
– Laboratory experience is essential.
– Experience with multiple cell culture models.
– Experience with protein detection techniques (Western blot, ELISA, imaging, flow cytometry).
– Experience with molecular biology techniques, development of stable cell lines.
– Ability to use automation is a plus.
– Experience with data analysis software.
– Excellent written and verbal communication skills.
– Detail oriented, highly motivated, flexible, and independent.
Source: Job Diva – Job Listing
POSITION SUMMARY:
Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support Client projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses.
Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies.
Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments.
ESSENTIAL FUNCTIONS: –
Executes laboratory experiments; makes detailed observations and analyzes data. – Prepares technical reports, summaries and quantitative analyses. – Maintains complete and accurate records. – Normally receives detailed directions on all work. – Makes suggestions to improve work processes. – Assists in reducing to practice patentable inventions. – Works on projects of moderate scope in which analysis of situation or data requires a review of identifiable factors. – Exercises judgment within defined procedures and practices to determine appropriate action. – May participate in cross functional technical team activities. – Presents and discusses data within group. – Monitors work to ensure quality, and continuously promote Quality First Time.
Knowledge, Skills and Abilities: –
Knows basic and some specialized laboratory techniques. – Familiar with searching scientific literature. – Skilled with use of word processing, spreadsheets, graphical and presentation software applications. Skills and experience on immunohistochemistry and histology, molecular biology (e.g. PCR, NGS, bioinformatics), brightfield and fluorescence microscopy, image processing, image analysis, computer programming and data analysis are highly desirable.
Source: Job Diva – Job Listing
Drives customer-centric service delivery, quality production, and optimization for impact and efficiency
Maintains high-quality data in and leverage analytics to drive data-driven decisions
Manages production agency/vendor management and UAT team to coordinate approval for launch
Adheres to processes and standards for campaign management and assess operational metrics in order to prioritize work and develop business-focused recommendations
Delivers Operational Excellence by identifying and implementing process improvements and informing standards that enable great customer experience
Uses expertise to influence overall service roadmap and portfolio
Tests pilots and drives adoption of new capabilities
Deep familiarity with service production marketing technology, processes, and tools
Digital media knowledge and experience in multichannel/digital marketing preferred
Ability to apply data and analysis to drive decision making
Strong project management skills to meet goals within constraints of time and budget
attention to detail to ensure quality and consistency of deliverables
Adept at vendor/agency management to maintain healthy partnerships and deliver operational excellence
Learning mindset and ability to identify/apply learning to other situations
Background/understanding of technology integration and related executional and process impact
Source: Job Diva – Job Listing
Duties:
Provide data review and data visualization for clinical trials
Program analysis datasets, tables, listings, and figures across several trials
Develop and comply with project/study programming standards and specifications following internal guidelines
Support quality control and quality audit of deliverables
Skills:
Expertise using SAS in the analysis and reporting of pharmaceutical data
Working knowledge of database design/structures
Experience with JReview and Spotfire is a plus
Education:
BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field
Source: Job Diva – Job Listing
The Regulatory Coordinator is responsible for providing operational regulatory and compliance support on development projects/major line extensions through development, registration, and approval including post approval commitments.
Major Accountabilities (Describe the main results of the role to be achieved)
Manage and prepare Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment , and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations
Contribute to Module #1 documents including FDA forms and cover letters for maintenance submissions with management oversight
Conduct monthly reconciliation to ensure timely submissions are in accordance with FDA regulations as well as meeting all *** requirements for submission-related activities
Support US regulatory compliance activities, including timely review and updates to product specific information as provided by program team representative into a compliance database (DRAGON), when applicable
Manage the user fee registration requests
Manage and execute drug shipment ticket review process (US)
In addition to regulatory manager, provide guidance to clinical functions on regulatory compliance activities, such as requirements for TOOs, VDRs, drug shipment etc.
Assist regulatory managers to support compilation and release of submissions to regulatory agencies as well as submission-related activities for regulatory responses to health authorities
Minimum of 2 years pharmaceutical experience desired
Prior publishing/Regulatory Operations experience desired.
Good communication and negotiation skills.
Proactive personality.
Fast and flexible, focused on timely delivery and stretch targets
Ability to plan and prioritize workload
Ability to work in a matrixed environment.
Ability to build effective relationships across teams/projects.
Source: Job Diva – Job Listing
Description:
We are looking for an experienced and talented senior staff engineer (senior architect) to join our software business unit platform team. Success in this role requires hands on working experience in API management and integration platform development, both frontend and backend, in cloud computing environment.
Responsibilities:
– Work with product and engineering management and other senior architects to create roadmap to shape the future of API and integration cloud platform in the software business unit to better serve our internal and external customers
– Design and implement both prototype and production code of several micro-services in the area of API lifecycle management, analytics, and/or integration framework
– Mentor junior engineers to create robust, testable and maintainable code to sustain rapid product development iterations
Requirements:
– 10+ years of industry experience with MS/BS degree in Computer Science, Mathematics, Physics or equivalent experience
– Excellent hands on full-stack coding skills in JavaScript, Java, SQL and NoSQL databases
– Comfortable picking up new technologies and get up speed quickly
– Working experience of Kubernetes, Docker containers, and leading cloud computing platforms
– Working knowledge of Artificial Intelligence and big data analytics is a plus
– Prior working experience in an API management and/or integration software vendor is preferred
Source: Job Diva – Job Listing
Description:
Provide operational leadership for assigned trials executing them on time and within budget
Overall coordination and management of clinical trials from startup to closeout
Liaise with other functional areas to identify issues, evaluate and make sound business decisions and ensure implementation of timely solutions.
Identify and select high-quality clinical vendors in conjunction with the appropriate team members
Assure that team is receiving high quality, on time deliverables from internal and external vendors.
Collaborate with other team members to coordinate the development and finalization of key study documents including protocols, case reports forms, informed consent documents, study management plans and final clinical study reports.
Lead or facilitate teleconferences with internal or external group.
Assume co-monitoring responsibilities as needed.
Communicate with Principle Investigator, Study Co-Coordinator, and/ CRO (if applicable) to proactively recognize problem situations and work with other team members as required to resolve issues
Manage the publication process in conjunction with the publications team to assure that submission timelines are met.
Monitor and report clinical trial status using standard and adhoc review & reporting procedures and identify issues that affect functions. Ensure that each function is accountable for their deliverables.
In collaboration with Project Management and utilizing various tracking mechanisms, manage clinical trial project milestones and budget. Proactively identify issues and escalate to appropriate managers.
Required Qualifications:
At least 5 years of experience in the management of clinical trials as a study manager, significant knowledge of overall clinical drug development and general clinical research operations in Big Pharma or CRO.
Ability to manage multiple projects simultaneously with strong organizational and planning skills.
Well-developed analytical and problem solving skills.
Communicates issues to Director with action plans for resolution.
Knowledgeable in all required regulatory and compliance standards and guidelines including ICH-GCP.
Experience of phase III and Phase IV as a study manager is required minimum 5 years at this level, global experience
Must have experience of set up and close out of phase II/III global clinical trials.
Experience of IVRS and eDC (inform ideally) set up is also required
Ability to effectively work with teams and promote collaborations.
Exceptional interpersonal skills including the ability to influence negotiate and resolve conflicts.
Excellent verbal and written communication skills and the ability to interact with all levels of management within the organization and to external business contacts.
Experience using the Inform database, PowerPoint and Excel software.
Independent judgment and decision-making skills with respect to functional responsibilities.
Innovative and motivated in optimizing clinical operations processes to meet deliverables.
Minimum BS or BA in related field; focusing on biological science or nursing preferred or equivalent.
Advanced Degree preferred
Experience in the epilepsy therapeutic area preferred, but not required.
Source: Job Diva – Job Listing
Job Duties:
• Perform daily animal health observations and animal care for rodents including weekends and holidays
• Perform cage changing and monitoring of food and water
• Maintain inventory of supplies, such as food, bedding, PPE, other general supplies
• Sanitize housing and procedure rooms, and maintain facility in good condition
• Operate cage washer and autoclave
• Perform technical procedures including restraint, euthanasia, anesthesia, recording of body weight and health observations
• Prepare animals for experimental procedures, including tattooing, shaving, implanting transponders under anesthesia.
• Assist with in vivo studies, including compound administration, health assessments, some tissue collection
Job Qualifications
High school diploma, plus 1 to 4 years of experience with small animal handling; LAT certification desired, or willingness to study toward certification.
• Ability to work weekends and holidays
• Proficient in rodent handling, restraint and PO dosing
• Experience with marmosets desired but not required
• Ability to work independently while maintaining communication with supervisor.
• Detail oriented, with good organizational and communication skills.
• Familiar with USDA and AAALAC guidelines and requirements
• Professional attitude; ability to work well with researchers and other technical staff.
• Ability to lift, pull and push 50 lbs.
WEEKEND HOURS REQUIRED. 4 HRS SAT and 4 HRS SUN. FLEXIBLE WEEK SCHEDULE.
Working Conditions
Work is primarily performed in office and animal facility settings. Due to the nature of the position, there is possible exposure to hazardous waste; chemical hazards, including explosives, corrosives, and carcinogens; radioactive and biohazardous materials.
Source: Job Diva – Job Listing
Duties:
Responsible for the execution and analysis of experiments and analytical procedures. Displays an investigative or technological orientation in designing, executing and interpreting experiments and analytical procedures. Investigates basic technical problems and performs routine scientific procedures and experiments under general supervision.
Plans and prioritizes concurrent experimental procedures. Integrates, complies, and tabulates data and assists supervisor in the analysis and interpretation of the results. May provide oral presentations on results to other department members. Works under active supervision.
Follows established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy. Contributes to the completion of milestones associated with specific projects. Failure to achieve results or erroneous execution may cause delays in program schedules, and may result in the allocation of additional resources.
Frequent internal company contacts. Infrequent inter- departmental and outside constituent contacts on routine matters.
Experience: 0 to 3 years.
Skills
HPLC
SDS-PAGE
A280 preferred
Education:
Bachelor's degree required
Source: Job Diva – Job Listing
Job Responsibilities:
Writing and editing test methods procedures (SOPs), validation/qualification reports/protocols and development reports for analytical methods.
Application of technical experience and understanding of CMC or analytics into the writing or reviewing of documents.
Generation of Excel templates and macros to allow for the generation of consistently formatted tables and graphs.
Must work effectively in a team environment, with individuals at all levels within the organization. Collect and interpret feedback to be incorporated into documents.
Write relevant compliance and operations related SOPs, generate technical templates etc. and professionally format documents.
Basic Qualification:
Experience writing technical documents for a CMC related area, preferably in method development/validation or product characterization with experience working a GMP regulated area.
Must have excellent planning, organization, and time management skills.
Must have a strong technical comprehension and writing capability along with verbal communication skills.
Expert in Microsoft Word, Excel and PowerPoint
Must have excellent attention to detail and ability to generate professionally formatted documents
The desired candidate will have the ability to work independently with limited supervision.
Source: Job Diva – Job Listing
Duties:
We are seeking a highly motivated scientist to participate in development, qualification, and transfer, as well as release and stability testing support, of analytical methods used for characterization of protein and gene therapeutics in early stage development (Phase I/II).
Platforms in use include spectrophotometry and ELISAs, gel and capillary electrophoresis, and liquid chromatography (e.g., affinity, SEC, and reversed-phase separations) for the purposes of drug substance and/or drug product lot release and stability testing.
Author assay protocols and technical reports, participate in sample testing and use of LIMS, and design, execute, and interpret laboratory experiments and data in conjunction with an electronic lab notebook.
Abilities to multitask and work independently or with a multidisciplinary team are desired.
This job is within a cGMP setting and requires excellent verbal and written communication.
Skills:
The successful candidate must have a strong ability to work independently and effectively, as well as handling multi-tasks spontaneously and meeting timelines efficiently and productively.
The preferred candidate should have a fundamental knowledge of cGMP, strong technical skills in protein analytics, and excellent compliance and organizational skills. The ability to write and communicate scientific data effectively is desired.
Education:
Ph.D. degree in Protein Biochemistry or related discipline and 0 to 2 years of experience in the biotechnology/pharmaceutical industry related to protein analytics.
Source: Job Diva – Job Listing
Duties:
The Statistical Programming Contractor supports statistical programming activities in the production of the analysis datasets, tables, listings, figures, electronic submission components, and complex ad hoc analyses. Depending on experience level, may lead a study.
Does both production and QC programming of SDTM datasets, analysis datasets, tables, listings, and figures, for multiple clinical trials using SAS software.
Ensures standards at a drug program level; integrates data across multiple studies or drug programs.
Works with minimal supervision under the direction of a lead programmer.
Communicates issues to lead programmer or manager.
Must meet timelines or communicate proactively and effectively if timelines are at risk so that plans can be adjusted.
Expected to contribute to departmental process improvement initiatives.
Skills:
Able to handle a moderate to large volume of complex tasks with minimal supervision.
Previous SAS programming experience, including SAS STAT, GRAPH and MACRO.
Able to handle ad-hoc requests with minimal guidance.
Previous relevant pharmaceutical/biotech industry experience.
Recognizes when negotiating skills are needed and seeks assistance when necessary.
Extensive knowledge of drug development process and clinical trials.
Excellent organizational, interpersonal, and communication skills.
Extensive knowledge of drug submission requirements, relevant ICH and FDA/EMEA guidelines, CDISC standards.
Education:
Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc. 3 to 10 years of pharmaceutical/biotech industry experience
Source: Job Diva – Job Listing
Description:
We are looking for Data Engineers to join our growing team of NFVCC core network data engine project. As a team member, you will be working and optimizing data pipeline, as well as, optimizing data flow and collections. The Data Engineer will have to research, develop and maintain tools used to architect, create, debug, analyze and maintain a network operation knowledge graph. The right candidate must be an expert on knowledge graph integration, and consistency.
Requirements
Experience in creating and maintaining knowledge graph data structures
Experience in semantic consistency checking
Ability to manipulate and analyze large scale, high-dimensionality data
Ability and experience in data integration
Experience with a relevant database management system
Ability to search for datasets and to integrate them in a coherent and consistent structure
Java, and/or Python experience
SQL, SPARQL or other graph database querying language experience
Qualifications
Degree (B.S/ M.S./Phd) preferably in statistics, computer science, computer engineering
3+ years of experience in creating and maintaining knowledge graph
Must be excited about demonstrate new algorithms in a fast and changing environment where solutions have not been already defined
Experience with machine learning
Source: Job Diva – Job Listing
© tech-observer 2019 All Rights Reserved.
Follow Us :
