Description:
Perform Statistical Analyses, review programming and data checking preferably using SAS. Primarily works with other Statistical programmers on ongoing clinical studies. Must work well both independently and with team members. Needs to be able to be on-time with deliverables, and for those deliverables to be of quality. Works with Statistician or Statistical programmer to assure results are consistent with expectations, and Quality control procedures are followed. Plans and carefully documents differences between programming results between program developer and Statistical QC programmer.
Perform statistical analyses and produce outputs for CSR, integration, publication, marketing research, etc. Confirms that tracking sheets are current for projects, and may also confirm that results are consistent with earlier generated results. Bachelors degree or above preferred. Mathematics, Statistics or Computer Science degree preferred. No pharmaceutical experience is required. Must, however, be detail oriented and process oriented. Good problem solving, writing, and communication skills required. Excel, Acrobat, and Word recommended. XML a plus.
Source: Job Diva – Job Listing
Responsible for designing, developing, and updating required technical documentation. Responsible for technical writing/editing for all types of documentation produced within a modern software development environment. Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.Documents programming standards and procedures.
SCIENTIFIC PHARMACEUTICAL PRODUCTION TECH WRITING EXPERIENCE
Technical writing abilities and good time management. Strong root cause analysis skills with cGMP experience. To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required.
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.
Skills:
HPLC
SDS-PAGE
A280 preferred
Education: Bachelor's degree required
Source: Job Diva – Job Listing
Duties:
Candidate to author/review/approve CMC technical documents in Company’s internal document system to support regulatory submissions (may include BLA, MAA, IND, supplements) to US FDA and international Health Authorities. Must have working knowledge of biologic/drug regulations (FDA, ICH, EU, etc) related to CMC. Provide regulatory guidance for development projects, post-approval CMC changes/variations. Must have working knowledge of GMPs. Must be well-organized, work with minimal management and meet aggressive timelines. Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.
Experience with drug/biologics licensure
Prior regulatory experience
Technical writing experience (CMC experience) Scientific background
Skills:
CMC/ Regulatory writing experience – 3 + years authoring CMC regulatory documents including Module 2 and Module 2.3
Scientific background, vaccines preferred Microsoft Office (word, excel, powerpoint) Documentum/ Veeva Applications Trackwise Applications ICH Guidelines GMP experience
Experience with drug/biologics licensure preferred
Prior regulatory experience
Education: BS in Biology/Chemistry or related field
Source: Job Diva – Job Listing
Maintaining and coordinating the Record Retention process of GMP documents for the Antigen Platform. This responsibility includes onsite and offsite record retention.
Creation and control of Production logbooks pre, post and during use.
Maintaining document control through Production Floor Support, including but not limited to exchanging inactive official copies of documents for active official copies of documents in real time.
Supporting production needs by being responsible for performing administrative tasks such as gathering and preparing documentation to support investigations, operational optimization and/or change controls/CAPAs
Ensure cGMP regulations regarding documents, logbooks and forms are adhered at all times for the Antigen Vaccine Platform.
Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
Experience: 0-3 years
Attention to details
Able to gown aseptically multiple times throughout the course of a day.
Working knowledge of cGMP is required
Good Communication skills both written and verbal
Proficiency in WORD, and EXCEL, and have a working knowledge of other MICROSOFT OFFICE programs.
Excellent organizational skills.
Sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.
Work quickly with a high degree of accuracy.
Technical Writing experience preferred
Previous experience working within a production department of a pharmaceutical company preferred
Candidate must be able to work extended and flexible hours (including weekends) when needed.
Source: Job Diva – Job Listing
Duties:
The successful candidate will be responsible for independently setting up a range of flow-based experiments that include routine flow cytometry, complex highly multi-parametric analyses, hematopoietic single cell sorting, and other specialized cell characterization methods.
He/She will be responsible for maintaining flow cytometry equipment and training users on the proper design of experiments, use of equipment and correct data analysis.
The qualified candidate should have a desire to build on their existing knowledge of cell phenotyping, and a willingness to take on new challenges toward the goal of building a state-of-the-art flow cytometry lab.
Perform cell sorting and manage sort requests.
QC instruments on a daily basis and troubleshoot problems; build and change cytometer configurations as needed.
Develop and perform multi-color staining assays for primary human and mouse phenotyping experiments.
Characterize and qualify reagents to be used in analysis and sorting assays, including FACS antibody panels and titers.
Perform data analysis using FlowJo and FACSDiva applications when needed.
Help train other users on all aspects of flow cytometry from planning experiments, acquisition and analysis.
Interpret and summarize experimental data and report summaries in team meetings, as needed.
Experience working in or running a core facility is a plus.
Experience running high content microscopy platforms, including Perkin Elmer Operetta and EMD Millipore ImageStream, and associated data analysis is a plus.
Experience with or a willingness to be trained on the operation of hematology analyzers (Advia, Beckman Coulter) is a plus.
Well versed in a variety of cell based methods with a strong understanding of tissue culture, cell biology, immunoassays, and general laboratory techniques.
Qualifications:
PhD degree with 5+ years flow cytometry experience in appropriate scientific area related to position. A degree in cell biology, immunology, molecular biology, microbiology, or biochemistry is preferred.
Have an understanding of flow cytometry fundamentals and experience with analyzers including: Client LSR II, Canto II and Guava EasyCyte HT.
Experience cell sorting on a Client FACSAria Fusion
Comfortable developing and running 6+ color FACS panels.
General ability working with Windows and MAC operating systems and computer hardware/devices.
Proficiency with the following software: Microsoft Office, FACSDiva, FlowJo, MACSQuantify, Forecyte and Graphpad Prism.
Source: Job Diva – Job Listing
JOB SUMMARY
Under the direction of their supervisor, this individual will be responsible for managing BLA applications and providing US regulatory support for marketed Company vaccine products, contributing US Regulatory strategies as a member of applicable Global Regulatory Teams.
Contributes to the development and oversees the successful implementation of regulatory strategies for assigned products, including submission and maintenance activities related to BLA applications.
Leads and/or participates on multi-disciplinary matrixed project teams that work to project deadlines while adhering to regulatory requirements for products and/or projects.
Consults with management to develop and communicate robust product-specific regulatory strategies to mitigate risk; works in conjunction with brand team management and global regulatory lead to provide advice and risk/benefit analysis to maximize value to stakeholders.
Serves as primary contact with FDA, manages FDA relationships ensuring communications are documented; establishes and maintains strong collaborative relationships with Legal, Medical, Marketing, Supply Chain, and Compliance.
Manages and participates in the development, monitoring and updating of standards and processes related to biologics regulations.
SKILLS:
Knowledge and understanding of complex medical and scientific subject matter.
Ability to work well within cross-functional teams.
Can demonstrate solid oral communication and writing skills.
Understanding of the U.S. pharmaceutical market place, and familiarity with medical terminology.
Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
Develops collaborative relationships to facilitate the accomplishment of work goals.
In conjunction with their supervisor, generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.
Can build networks to obtain cooperation.
Unquestionable ethics, professional integrity and personal values consistent with the Company values.
Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well.
Deals with people in an honest and forthright manner representing information and data accurately.
EDUCATION:
Bachelor’s degree from an accredited four-year college or university
Source: Job Diva – Job Listing
Manages project information to support decision making by project teams, Life Cycle Teams (LCTs) and Life Cycle Committee (LCC).
Responsibilities
• Manages project information to support project teams, LCTs and LCC decision making.
• Tactical coordination of timelines/budgets for all projects and functions within a LCT:
• Manage execution of cross-functional plans and track of progress of activities;
• Integrated resource and budget planning;
• Identify gaps, potential bottlenecks or delays and challenge assumptions;
• Risk management incl. critical path, risk assessment, scenario creation and analysis;
• Proposes options to close gaps and get projects back on schedule;
• Single point of control for project data (collect from functions/finance; owns version management and release of changes);
• Compile and communicate project reports.
• Guides team processes, ensuring consistency, transparency and optimization.
• Implements / pulls in best practices to project teams; fosters continuous improvement by ensuring knowledge, experience exchange.
• Guides and manages preparation for project milestone reviews.
• Defines, measures and reports key performance indicators for their projects, enabling teams and functions to measure and improve quality, efficiency and effectiveness.
• Meeting management (sets agenda, organizes meetings, edits minutes).
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.
Skills:
HPLC
SDS-PAGE
Education: Bachelor's degree required
Source: Job Diva – Job Listing
POSITION SUMMARY:
Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support Company projects. Executes laboratory experiments; makes detailed observations and analyzes data. 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.
SKILLS:
– Knows basic and some specialized laboratory techniques. – Familiar with searching scientific literature. – Skilled with use of word processing, spreadsheets, graphical and presentation software applications.
EDUCATION:
– Requires Bachelor’s degree in Science.
Source: Job Diva – Job Listing
Position Summary
The resource should play the role of a functional SME along with Application support.
Should possess functional knowledge of treasury management products such as Kyriba/FireApps & Plan On
The role is responsible for lifecycle management, driving continual improvements, and the management of change of the IT service for applications, ultimately ensuring high customer satisfaction.
The role also negotiates Operational Level Agreements (OLAs) with the service providers of underpinning IT services and ensures that the relevant resources are engaged and coordinated.
Ensures effective management of IT Services for applications across their entire lifecycle within an agreed governance model
Acts as a functional SME in Treasury management and Kyriba tool
Ensures high customer satisfaction
Fix issues using Knowldge articles or route the ticket to relevant support groups
Coordinate with various vendors and ensure the avaiability of app at all time
Negotiates SLAs with customers and BIMs, and OLAs with Service Providers of underpining services to make sure the customer needs are met
Approves project handover to operations
Captures Demand effectively from various areas e.g. Business, IGM, Infrastructure
Contributes to and actively participates in continuous improvement / cost reduction programs.
Proposes and implements operational improvements, based on a fair technical and good domain understanding, that provide value to IT and/or business
Plan, budget and resource all initiatives requested by the business area for a particular application(s).
Progress is tracked, risks and issues are managed and changes to plans are communicated regularly to all stakeholders
Monitors Service Levels, communicates regularly about KPIs to appropriate stakeholders and defines plans for continuous improvements, including Service Providers when appropriate
Acts as a first point of escalation for operational issues for all stakeholders
Ensures adherence to quality standards as defined by the IT Organization
Ensures the applications are audit ready and provide appropriate response to audit / IGM assessment findings and recommendations
Minimum requirement is a Bachelor's Degree in Computer Science or a related discipline.
Good oral and written communication skills.
Ability to communicate and interact with peoples at all levels globally
>=8 years of professional experiences in areas such as project management, software engineering, validation, regulatory and compliance. Demonstrated ability to lead people.
Domain knowledge : Life Science Domain, Treasury Management, Contract Management (Plan On)
Source: Job Diva – Job Listing
Position Purpose Develops methods, designs, plans, performs and interprets scientific experiments for the advanced analytical analysis of starting materials, in-process materials, and finished materials. Perform material analysis by utilizing chromatographic method development and execution.
Major
Accountabilities Independently designs multiple studies or develops non-standard procedures of higher complexity which requires studying multiple variables and critical attributes to achieve functional deliverables. Upon completion, work is reviewed for adequacy in meeting objectives. Provides technical leadership by troubleshooting problems of moderate complexity and developing thorough, practical solutions that are consistent with organization objectives and require creativity. Has general knowledge of most typical functional activities and deep knowledge in 1-2 specific areas. Executes studies and conducts testing without deviation. Analyzes data from multiple, complex studies to derive a decision on functional deliverable. Thoroughly and clearly documents experiments in laboratory notebook, prepares technical documents for single, multiple, standard, complex studies. Writes sections of regulatory documents related to function deliverables. Communicates and collaborates with colleagues within the function and within sub-teams. Communicates functionally with supervisor and mentor. Participates constructively in functional -teams and at lab meetings. Offers assistance to co-workers. May lead a functional sub-team to achieve specific functional.
Preferred experience and troubleshooting abilities with chromatographic techniques such as gas chromatography (GC) and with high performance liquid chromatography (HPLC or UPLC), in additional to other standard analytical chemistry analyses. Experience with medical device analytical chemistry testing according to ICH and ISO guidelines.
Key Performance
Indicators Quality – No critical audit observations. Quality – Formal CAPAs and deviations not more than 30 days past due. Adherence to standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards. Measurable contributions to increasing efficiency and productivity in the work related to assigned projects. Adherence to costs, quality, quantity, and timelines for all assigned tasks. All studies conducted are thorough, technically sound, completed in a timely manner and will meet regulatory guidelines.
Source: Job Diva – Job Listing
Position Purpose Develops methods, designs, plans, performs and interprets scientific experiments for the advanced analytical analysis of starting materials, in-process materials, and finished materials. Perform material analysis by utilizing chromatographic method development and execution.
Major
Accountabilities Independently designs multiple studies or develops non-standard procedures of higher complexity which requires studying multiple variables and critical attributes to achieve functional deliverables. Upon completion, work is reviewed for adequacy in meeting objectives. Provides technical leadership by troubleshooting problems of moderate complexity and developing thorough, practical solutions that are consistent with organization objectives and require creativity. Has general knowledge of most typical functional activities and deep knowledge in 1-2 specific areas. Executes studies and conducts testing without deviation. Analyzes data from multiple, complex studies to derive a decision on functional deliverable. Thoroughly and clearly documents experiments in laboratory notebook, prepares technical documents for single, multiple, standard, complex studies. Writes sections of regulatory documents related to function deliverables. Communicates and collaborates with colleagues within the function and within sub-teams. Communicates functionally with supervisor and mentor. Participates constructively in functional -teams and at lab meetings. Offers assistance to co-workers. May lead a functional sub-team to achieve specific functional.
Preferred experience and troubleshooting abilities with chromatographic techniques such as gas chromatography (GC) and with high performance liquid chromatography (HPLC or UPLC), in additional to other standard analytical chemistry analyses. Experience with medical device analytical chemistry testing according to ICH and ISO guidelines.
Key Performance
Indicators Quality – No critical audit observations. Quality – Formal CAPAs and deviations not more than 30 days past due. Adherence to standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards. Measurable contributions to increasing efficiency and productivity in the work related to assigned projects. Adherence to costs, quality, quantity, and timelines for all assigned tasks. All studies conducted are thorough, technically sound, completed in a timely manner and will meet regulatory guidelines.
Source: Job Diva – Job Listing
Description:
Dues and responsibilities include providing strategic leadership and oversight of therapeutic area-specific scientific communication activities, including:
o Understanding of the medical strategies, disease areas, and objectives necessary to provide strategic input to a broad range of stakeholders on matters related to scientific communications planning and data dissemination/disclosure
o Development and execution of the strategic scientific plan, including the scientific communication platform, strategic publication plan, and additional educational resources that align with program objectives
o Lead scientific communication team to ensure alignment of cross-functional stakeholders on the external scientific communication plan
o Conduct gap analyses to identify medical/scientific communication needs or opportunities
o Manage tracking of company- or investigator-led publications
o Monitor related industry issues for publication planning (e.g., ICMJE), ensure adherence to company best publication practices, and participate in educating internal stakeholders about best publication practices
o Provide writing and editorial support for Medical Affairs-driven publications
o Track timelines and milestones for projects contracted with communication agencies providing tactical support and provide status reports to Medical Communications Senior Management
o Ensure work is high quality and developed on time and budget
Additional duties may include:
* Assist Head of Medical Communications in managing team members, including assigning tasks and reviewing efforts of direct reports, and collaborating with team members to advanced Seattle Genetics’ scientific communications
* Recommend and implement innovate approaches for enhancing Medical Communications deliverables
* Support achievement of broader Medical Affairs organizational goals, projects, and timelines as needed
Source: Job Diva – Job Listing
Duties:
Responsible for initiating, directing and executing scientific research, development and manufacturing process strategies to support new and existing products. Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems. Plans and executes laboratory research.
Maintains broad knowledge of state-of-the art principles and theories. Makes contributions to scientific literature and conferences. Serves as an in-house and outside consultant. May act as a spokesperson for corporate scientific affairs and advise top management. Participates in development of patent applications. Promotes and participates in the professional development of scientists and laboratory facilities. Uses professional concepts to contribute to the development of product or process principles and to achieve objectives in creative and effective ways.
Conducts research and development activities for products, methods and/or processes. – Projects are assigned with defined scope and goals. – Direction is provided by more senior scientists, management or project leader. – Participates in efforts to define new components, products or processes and identify technical challenges. – Makes suggestions to improve work processes. – Creates potentially patentable components for systems, reagents or processes.
Plans and executes assigned projects; utilizes thorough technical and theoretical understanding of numerous techniques. – Analyzes data, evaluates results, forms conclusions and provides/implements process or document improvements. – Applies advanced scientific knowledge to projects. – Executes experiments; participates in experimental design. – Utilizes DOE where appropriate. – Participates in cross functional technical team activities. – Shares knowledge and expertise with others. – Participates in project planning, process updates and contributes to experimental design. – Prepares and delivers presentations of project results to own or other groups. – Monitors work to ensure quality, and continuously promote Quality First Time.
Knowledge, Skills, and Abilities: – Demonstrates potential for technical proficiency, scientific creativity, collaboration with others and independent thought. – Strong understanding of scientific principles and concepts. – Applies advanced technical writing skills to produce reports and documents.
Source: Job Diva – Job Listing
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