Client IT is looking for an experienced and hands-on IT Operations Manager to lead the day-to-day support of R&D systems for a global user base. This is a leadership position which requires a customer service focus and ability to manage a global support team.
This position will be work closely with R&D business users, IT teams, project teams, Lead / assist implementations in a GxP environment.
Key Responsibilities:
Supervises Level 2 and Level 3 global support teams on a daily basis.
Monitors and reports support team performance to IT and Business stakeholders
Is escalation point for all urgent support and/or system issues
Plans, supervises system upgrades and continuous improvement initiatives
Collaborates with IT Quality and QA in planning and approving change controls
Supervises vendors through regular checkpoints measuring performance against SLAs
Leads the IT Team in preparing and supporting Inspections
Collaborates with global Infrastructure teams in coordinating and communicating changes
Qualifications
The successful candidate will demonstrate the following qualities:
Project and people management skills and the ability to lead and work as part of a team
Ability to maintain open and frequent communication with support team and internal stakeholders.
Excellent written and communication skills
Experience presenting to senior IT and Business colleagues
Good listening skills with ability to make timely well-informed decisions
Ability to track project activities and track progress to business value realization
Willingness and ability to train and mentor staff
Ability to oversee multiple, projects in a simultaneous and compliant manner.
Experience
5+ years of experience in managing/leading IT support team in a GxP environment
Experience in technologies such as Oracle Clinical, Veeva, SharePoint, SAS, ELN
Thorough understanding of GxP Validation process
Biotech / Life Sciences experience is a plus.
Source: Job Diva – Job Listing
Duties:
Quality Assurance (QA) Associate I
Provide exceptional customer service to client's internal and external customers in all assigned tasks.
Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP)
Provide floor support for GMP activities
Monitor for GMP compliance of all in-process activities during GMP processing.
Perform AQL particle inspection of in-process product vials prior to packaging.
Gown qualified for entry into controlled manufacturing areas to perform quality functions as assigned.
Perform real time review of executed Batch Documentation and prepare for eventual disposition by QA management.
Organize documentation for Batch History Files and scan files.
Ability to search, document and generate quality event reports for Batch Release.
Assist with regulatory inspections and partner audits with management oversight.
Maintain databases as required
Other duties as assigned
Skills:
Strong knowledge of GMPs and their application
Prior experience with Batch Documentation review
Ability to work proactively and cooperatively with managers and operational staff to solve quality problems
Ability to manage multiple responsibilities with a high degree of self motivation
Good written, oral and interpersonal English communication skills
Ability to use Microsoft Word and Excel applications
Source: Job Diva – Job Listing
Partner w/dev team and support the documentation like system and data flows. Plan, draft and support communication efforts as needed
Facilitate workshops – story-boarding workshops, translate story-boarding artifacts into an electronic format and provide input in design sessions
Work closely with Project Manager / Scrum Master, Technical Lead, Developers, Software Quality Assurance to accomplish a successful project delivery, focused on Minimum Viable Product (MVP)
Support Organization Change Management tasks as needed
Define Agile structures and apply Agile principles (Themes, Epics, User Stories, etc.)
Document and analyze current and future business process models
Document and analyze requirements, scope, business rules (use cases) and user stories for any requests.
Clearly communicate keeping IT and the business stakeholders updated on progress, dependencies, risks, issues, key metrics
Plan user acceptance test (UAT), create UAT scripts and facilitate UAT and post-UAT outcomes and next steps
Perform knowledge transfer to training and communications teams
Support user deployment activities as needed
Be able to work flexible hours with teams at different time zones.
Project coordination, manage timelines, meet stakeholders, organize meetings
The IT Business Systems Analyst will be responsible for working closely with different business areas to define and drive technology-enabled solutions, with a strong focus on application development and system integrations with the necessary stability, usability, and scalability.
The IT Business Systems Analyst will be supporting projects in Corporate Relations working with many different functions around Roche/*** and experience at SENIOR level is required.
8+ years of experience working with business teams to define business problems, analyze business requirements & define user stories
Strong communication and documentation experience and skills.
Strong skills in critical thinking and analysis, small and large group facilitation skills
Strong verbal and written communication skills; ability to navigate, negotiate, influence across stakeholders
Strong business analysis experience in the area of application development and systems integration
Demonstrated success handling initiatives of high complexity and risk
Experience with various IT solutions, including SAP solutions like Workday and Servicenow
Experience with Agile methodology
Ability to multitask, work in a fast paced role and required the art of agility, flexibility and time management
Source: Job Diva – Job Listing
Senior Biostat programmer
Oncology PCU
To support the Oncology Business Group Biostatistics team by carrying out and conducting programming activities of statistical programmers, and coordinating with external vendors (as required), Statisticians, and other business functions to ensure timely and accurate programming and validation activities for clinical studies. Contributes to the overall efficiency and best practice running of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
Strong technical skills and Oncology experiences supporting submissions are required.
Main duties/responsibilities:
1. Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (Client), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications). Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files). Working with external vendors in order to develop or monitor the content and structure of SAS data sets.
2. SDTM and ADaM technical knowledge required. In addition, knowledge of agency requirements including ICH, FDA, and other guidances is strongly recommended. Knowledge of current FDA submission process (Define.xml, etc.) is strongly recommended. Developing and maintaining SOPs, SWPs and other related technical documents, providing input to the Database and CRF Development. Providing input in developing statistical analysis plans, producing specifications of analysis datasets, validation plans, and other related documents. Good understanding with different phases of clinical trials, protocols, and CRF designs.
3. Maintaining standards for programming activities (SDTM, ADaM, directory structure, etc.), and guiding/coaching Statistical programmers.
4. Working independently as well as in teams to accomplish tasks and goals defined by supervisor. Attending required training and meetings and bringing in new ideas to improve the programming process.
Minimum of Bachelors degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred. Strong educational background is expected.
Minimum 8 years experience in SAS programming in biostatistics department environment for phase I-IV clinical trials in a pharmaceutical/CRO environment. Lead Programmer experience is expected.
Strong managerial / technical understanding of programming and clinical related issues along with an ability to demonstrate significant leadership of SAS programming technical activities in a clinical pharmaceutical/CRO environment. Understanding of submission-related activities and experience with agency-related requirements expected. Define.XML knowledge and familiarity with a submission process is preferred.
Oncology and in-depth ADaM programming required. Submission support with compliance is expected. (this text is what was sent to you earlier and should be ok.)
Skills and aptitude required:
Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. Knowledge of SDTM and ADaM standards.
Proven experience with UNIX and Windows operating systems.
Understanding of the software development life cycle.
Understanding of FDA guidelines.
Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
Applies good judgment and demonstrates initiative to resolve issues. Proactive and effective working. Accountable. Leadership expected.
Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required
Advanced Degree
Source: Job Diva – Job Listing
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.Provides assistance in the execution of experiments and analytical procedures by performing routine scientific procedures and experiments according to detailed protocols. Integrates, compiles, and tabulates data and reports results to supervisor. Work is closely supervised. Assignments are task-oriented with detailed instructions. Follows standard practices to obtain data. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group. Experience: 3 to 6 years.
Hands-on experience with LC/MS, preferably on small molecule quantification
Hands-on experience with biochemical assay
Hands-on experience with western blot or ELISA
Excellent laboratory, computer, documentation, and organization skills, as well as good oral and written communication abilities
Source: Job Diva – Job Listing
Summary:
To support the Oncology team by carrying out and conducting programming activities of statistical programmers, and coordinating with external vendors (as required), Statisticians, and other business functions to ensure timely and accurate programming and validation activities for clinical studies. Contributes to the overall efficiency and best practice running of the Biostatistics group, demonstrating the ability to work efficiently and to a high standard within a clinical team environment.
Strong technical skills and Oncology experiences supporting submissions are required.
Duties:
Required:
Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related science discipline. Masters preferred. Strong educational background is expected.
• Minimum 8 years’ experience in SAS programming in biostatistics department environment for phase I-IV clinical trials in a pharmaceutical/CRO environment. Lead Programmer experience is expected.
• Strong managerial / technical understanding of programming and clinical related issues along with an ability to demonstrate significant leadership of SAS programming technical activities in a clinical pharmaceutical/CRO environment. Understanding of submission-related activities and experience with agency-related requirements expected. Define.XML knowledge and familiarity with a submission process is preferred.
• Oncology and in-depth ADaM programming required. Submission support with compliance is expected. (this text is what was sent to you earlier and should be ok.)
• Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. Knowledge of SDTM and ADaM standards.
• Proven experience with UNIX and Windows operating systems.
• Understanding of the software development life cycle.
• Understanding of FDA guidelines.
• Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
• Applies good judgment and demonstrates initiative to resolve issues. Proactive and effective working. Accountable. Leadership expected.
• Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required
Source: Job Diva – Job Listing
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Learn about and understand the basics of what kind of scientific data we collect and manage in this translational area of research at gRED. Understand trends in data file types, volume and associated metadata for exploratory research.Work cross-functionally with key contacts from other project teams in order to facilitate discussions around software integration plans or new use cases. Partner with our tech lead(s) to document stories and epics in JIRA and put our developers on the top priority tickets ensuring we can meet near term objectives for development. Do gap analysis, solution evaluations and proposals, ensure alternative solutions are explored and that selected solutions are scalable. Identify opportunities for streamlining or automation in data management processes. Employ tools like workflow modeling, activity diagrams. Make and maintain documentation: user guides, status updates, timelines, internal wiki application/project documentation, compliance documentation for internal risk assessments, vendor assessments and more. Generate polished and concise communication tools for larger projects with minimal oversight from the project lead or project manager (Project charters, requirement documents, use case documentation, lessons learned/retrospectives, project delivery summaries, release announcements). Generate test scripts and run user acceptance testing. Use testing summary info to ensure releases are well vetted prio r to Go/No Go decision meetings.Manage stakeholders effectively and understand the business needs from scientific and data management perspectives.
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| Education: |
Scientific background or have worked in Biotech/Pharmaceutical R&D + BS/BA or a higher degree with 4+ years relevant experience. |
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Source: Job Diva – Job Listing
Description:
We are looking for CPU Design Verification Engineers at various levels for a family of high-end 64 bit super scalar micro-processors.
Responsibilities (depends on the detailed assignment, the candidate may actually carry out a portion of the responsibilities below):
Responsible for the verification of a CPU sub-block(Instruction fetch, Out-of-Order, Load Store Unit, Level 2 Cache, MP cache coherency) at the full-chip level
Draft and review the test scheme and test plan
Work with a team of DV engineers in development of all test cases at the core-level (developing test-cases using an in-house random test generator)
Develop assertions, checkers, functional coverage according to the testplan
Run nightly regressions, triage & debug failures.
Requirements:
4-10 years of design verification experience in micro-processor design, with programming ability in C, C++, UVM and System Verilog.
Knowledge in CPU verification.
Must be a highly organized, detail-oriented self-starter, who works well independently, as well as in a team environment.
Masters degree preferred.
Good verbal and written communication skills.
Preference for candidates who have previous experience in core-level CPU verification and assembly programming in ARM, RISC-V, X86.
Source: Job Diva – Job Listing
Duties:
Develops global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, vaccines and/or consumer health care products) in collaboration with other parts of GRA. Assures effective involvement with change control systems. Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies. Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.
Skills:
Global operational experience with a mid/large-size Regulatory CMC and Devices Organization.
Must have some knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues.
Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences.
Fluency (oral and written) in English language is strongly recommended.
Potential to be able to mentor and train other contractors is desirable but not essential.
Be proficient in the use of databases and tools (Regulatory databases, Excel, PowerPoint, etc.).
Education:
Minimum of a Bachelor's Degree; advanced degree (Masters, PhD) in a science/health field (e.g., Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable.
An understanding of Regulatory CMC and eCTD content Modules 1-3 through technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) or direct Regulatory CMC experience is required.
Source: Job Diva – Job Listing
We are seeking a highly motivated bench scientist to join our multidisciplinary Genomics team to work closely with our diverse group of disease area partners to impact drug discovery and development.
Our Genomics group, within the Chemical Biology and Therapeutics drug discovery platform, applies state of the art genomic technology solutions to the discovery of Client drug targets, identification of new therapeutic modalities and characterization of their mode of action. Further, we continuously strive to identify, evaluate, and develop new genomic technologies (e.g., CITE-seq, scATAC-seq, spatial transcriptomics) to remain at the cutting edge of target and drug discovery.
Key responsibilities
Independently operate Illumina Sequencers (HiSeq, NovaSeq, MiSeq)
Independently QC different types of pooled sequencing libraries on Tape Station, Q-Bit, Bioanalyzer
Learn, independently run, optimize and troubleshoot NGS workflows like RNA-Seq, scRNA-Seq, targeted sequencing, whole exome/genome etc.
Develop, evaluate and implement custom NGS workflow tailored to specific drug discovery projects
Work collaboratively in an interdisciplinary team of NGS scientists, cellular biologists and computational biologists to apply genomic technologies to further target and drug discovery efforts
Own some laboratory operations responsibilities like maintenance of specific instruments, supplies, etc.
Present data within group and at project or unit meetings, contribute to internal and reports
B.Sc. or M.Sc. in Molecular Biology, Biological Sciences, Biotechnology, Bioengineering or related fields with 5+ years of relevant laboratory experience
Strong understanding of NGS technologies including molecular biology, sample preparation (including liquid handling automation), sequencing, data QC and interpretation
Hands-on experience with Illumina sequencing platform and NGS library preparation
Strong communication, presentation, organizational, interpersonal and teamwork skills are essential
Detail-oriented, self-motivated and scientifically driven with proficient reasoning skills in experimental design and data interpretation
Ability to work semi-independently in a multidisciplinary, fast-paced, dynamic and results-oriented environment
Source: Job Diva – Job Listing
We are seeking a highly motivated bench scientist to join our multidisciplinary Genomics team to work closely with our diverse group of disease area partners to impact drug discovery and development.
Key responsibilities
Independently operate Illumina Sequencers (HiSeq, NovaSeq, MiSeq)
Independently QC different types of pooled sequencing libraries on Tape Station, Q-Bit, Bioanalyzer
Learn, independently run, optimize and troubleshoot NGS workflows like RNA-Seq, scRNA-Seq, targeted sequencing, whole exome/genome etc.
Work collaboratively in an interdisciplinary team of NGS scientists, cellular biologists and computational biologists to apply genomic technologies to further target and drug discovery efforts
Present data within group and at project or unit meetings, contribute to internal and reports
Education:
B.Sc. or M.Sc. in Molecular Biology, Biological Sciences, Biotechnology, Bioengineering or related fields with 1-3 years of relevant laboratory experience
Some understanding of NGS technologies including molecular biology, sample preparation (including liquid handling automation), sequencing, data QC and interpretation
Hands-on experience with Illumina sequencing platform and NGS library preparation is a strong plus
Strong communication, presentation, organizational, interpersonal and teamwork skills are essential
Detail-oriented, self-motivated and scientifically driven with proficient reasoning skills in experimental design and data interpretation
Ability to work semi-independently in a multidisciplinary, fast-paced, dynamic and results-oriented environment
Source: Job Diva – Job Listing
Manages clinical and lab services projects from initiation through contract completion. Applies project management skills and experience in delivering projects on time, within budget and with high customer satisfaction. Facilitates cross-functional interactions to complete the assigned projects within the deadline and compliance with protocol.
This job is second in the Clinical Sciences project management job series comprising four levels. The employee is assigned on projects that may be limited in scope and/or of low to medium complexity. It may involve collaboration with other Clinical Sciences Program Specialist Senior or Clinical Sciences Program Manager.
| Responsibilities |
| Manages clinical testing and lab services projects from initiation through contract completion in collaboration with Specialist Senior or Program Manager. |
| Performs tactical coordination of timelines for all projects and functions within CDx Pharma Services and: – Develops project plans, establish and coordinates timelines for assigned projects and functions. – Manages execution of cross-functional plans and tracks progress of activities – Identifies gaps, potential bottlenecks or delays and challenge assumptions – Proposes options to close gaps and get projects back on track. |
| Oversees and guides day to day activities of sample process flow and accurate reporting of results. Implements / pulls in best practices within the clinical sciences team; fosters continuous improvement by ensuring knowledge and experience exchange. |
| Guides and manages cross-functional interactions to complete the assigned projects within the deadline. |
| Interface with resources outside of the company (Contract Research Organizations (CROs), site investigators, client counterparts, etc.) and serves as single point of contact |
| Bachelor's Degree | in a related field or equivalent combination of education and work experience. | |||||
| Master's Degree | in a related field | |||||
| Specific Project Management Training, or Clinical Research training and/or certification. | ||||||
| 3 years | of project and/or clinical trial coordinator/management experience. | |||||
| Experience with projects that require rapid activity/milestone achievement. | ||||||
| Experience in clinical trial management and knowledge of bio-sample (clinical testing) management and process flow preferred. | ||||||
| Previous experience with standard project management process (PMI) desired. | ||||||
| Diagnostic and/or Pharmaceutical industry and relevant diagnostic area knowledge preferred. | ||||||
Source: Job Diva – Job Listing
· Responsible for eCOA project timelines, translations, eCOA study specifications, executing UAT, and ensuring collection of eCOA is in accordance with Standard Operating Procedures (SOPs) and ICH/GCP.
· Provides input into protocol development as it relates to clinical outcomes
· Responsible for reviewing and approving project related eCOA study documentation during the course of the Project Lifecycle
· Supports internally sourced studies and studies outsourced to Clinical Research Organizations (CROs)
· Responsible for creating and enforcing eCOA systems standards, managing vendor performance, and supporting training & education of stakeholders.
· Defines and supports strategy for eCOA migration and COA validation
· Demonstrated knowledge of eCOA system development processes
Source: Job Diva – Job Listing
This role would function as the primary lead on documentation, testing, maintenance, and operations; participate in the requirements and process analysis; Validation & Testing including writing and executing test cases; function as the technology analyst; partner with the Business Technology team members on all technical aspects of the project; document throughout the whole SDLC, proficient in SCRUM/Agile methodology, proficient in wireframe, visio/flow charts, and presentations.
QC Vera/Client ALM, Jira, Having experience in Pharma (specially in Biopharmaceutical), regulatory compliance knowledge is plus.
Prefer Boca Raton at least for initial period until team starts performing smoothly
May be 10% or less
Analysing and Defining Requirements
Responsible for the elicitation and analysis of business requirements in collaboration with various stakeholders and effectively translates these into functional requirements of the target solution. Identifies and establishes scope and parameters of systems analysis to define outcome criteria and measure-taking actions. Leads and coordinates a team utilizing internal and external resources to deliver systems analysis and solution design.
Drafting and Designing
Responsible for identifying the design of the target solution and preparing the required system design documentation (architectural specifications, diagrams and charts, functional and configuration specifications) to ensure the visualization of the technical implementation of user requirements, and to provide direction to system programmers
Collaborates with Infrastructure specialists and directs as appropriate to deliver the target technology environment.
Implements the design by means of configuration and software development using internal and external resources
Testing and Validation
Contributes to the compilation of validation planning in agreement with a Quality position Controls and monitors the implementation of the defined measures in the validation plan
Prepares test cases and scripts that are relevant to the design and functional requirements while adhering to CSL defined quality and governance standards and procedures
Collaborates with Process Owners/Business stakeholders to ensure test applicability
Coordinates or conducts system functional testing with internal or external resources as appropriate
Prepares training materials and user manuals
Designs and conducts user training sessions, with emphasis on relating the configuration and technical setup to the functional/business requirements and defined CSL enterprise application standards.
Operations and Support
Responsible and accountable for the ongoing operation and maintenance of applications for the assigned IT functional areas
This includes providing 2nd or 3rd level incident support, change management, and maintaining the upkeep of technical records and documentation.
Proactively communicates the status of ongoing daily support and problem resolution.
Ensures effective problem analysis and resolution of issues of diverse scope in a timely fashion and escalates issues when needed to appropriate levels of IT or Business.
Provides off hours support as it relates to IT functional area
Project Work
Assumes project responsibilities as assigned for small to large scale projects (in terms of cost, scope, complexity and business criticality), that are either locally or globally managed
Performs matrix roles as assigned for local and global projects
Contributes to the definition of plans and manages projects involving all aspects of the technical solution including data sourcing, migration, design, implementation, and quality assurance.
Team Work
Leads by example in working collaboratively with internal employees, vendors, and consultants to effectively implement solutions
Develops and maintains mutually productive relationships in the workplace. Builds and leverages their own networks of expertise formed with other senior internal and external personnel for the benefit of the team.
May contribute to departmental budget and resource planning, as directed
Directs and conducts research and analysis on new and innovative solutions, releases, enhancements and considers their applicability to CSL.
Leads the identification and implementation of means to improve the qualities and efficiencies of IT processes, systems, and results
Keeps abreast of current technologies and professional concepts as it relates to the assigned IT functional area
Maintain Regulatory Compliance
Effectively follow global IT procedures and policies are followed consistently as defined by our Quality Management System (QMS)
Follows the appropriate global regulatory guidelines and current Good Manufacturing Practice (cGMP)
Conducts directed investigational activities to support the development of enterprise-wide application strategies, designs, and plans that can be integrated with and support Business strategies and the resulting Application Portfolio
Is responsible for engaging with Application vendors in alignment with CSL and CSL stakeholders and strategy
Source: Job Diva – Job Listing
Join a team dedicated to supporting downstream process development and other activities within Biologics Purification Development (R&D).
Independently performs tasks which include preparation of buffer solutions, cleaning and sanitization of labware, equipment preparation and sterilization, and assistance with ordering, stocking and organizing chemical and non-chemical supplies. Clean and organize laboratories, common equipment, lab areas, and other parts of the building as needed. Depending on performance, responsibilities may expand to include activities such as packing of chromatography columns, execution of chromatography and filtration operations, execution of analytical assays (e.g. HPLC, ELISA, SDS-PAGE), and/or execution of scientific experiments. May involve work with hazardous materials. On the job training will be provided.
A general knowledge of laboratory procedures, equipment and terminology. Able to carry out tasks according to verbal and written instructions. Should be able handle and prioritize multiple tasks simultaneously. Demonstrated interpersonal skills and effective communication and teamwork skills required. Demonstrated ability to operate and care for laboratory equipment. Requires physical demands of lifting up to ~25 pounds.
Source: Job Diva – Job Listing
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