Job Summary
The Senior Manager/Manager serves as a QCFU resource for managing the compliance of CMOs (Cell banking, Bulk Drug Substance, Packaging/Labeling) and external testing labs to ensure product and associated data adheres to cGMPs, EMEA, ICH and JP regulations, and Client requirements. This role participates in the resolution of CMO operational issues, maintains an effective working relationship with CMO’s and internal team members, tracks quality related issues, and participates in CMO business meetings as required.
This position works with DI+, PMCFU, and Exton CMC Program Management on a day-to-day basis to ensure review and approval of internal/ external deviations and change controls, master and executed production batch records, test methods, release specifications, qualification/ validation/ stability protocols and reports, quality agreements, reference standard implementation, and BLA/IND/IMPD documentation.
This role is responsible for batch disposition and supporting external audit activities, where required.
This position works independently to ensure processes and products produced in the development and commercial phase within adhere to international GMP requirements. The decision-making scope of this position requires the person to determine suitability of product for further processing and eventual use in clinical and commercial product.
This position will support the creation and improvement of Quality Systems, while ensuring seamless and efficient efforts are applied to project activities.
This role ensures compliance with established policies and procedures.
Essential Functions
1. Assess suitability of cell banks, bulk drug substance, and packaged / labeled drug product for further processing and eventual use clinical and commercial product
2. Ensure CMO compliance to international GMP regulations as well as Client expectations including trending and evaluation of issues for impact to product on a continual basis as well as external audit support
3. Support review of technical protocols, reports, batch records and regulatory documentation (BLA/IND/IMPD) with emphasis on adherence to agreed quality systems and international regulations
4. Support review of deviations, OOS, and change controls affecting both internal and externally approved processes/ products including corrective action recommendations and approval of final actions
5. Develop, implement and maintain processes and procedures to support quality systems specific to the CMO interactions; Ensure processes and procedures are adhered to, consistent with GMPs, and value-added.
Requirements
• B.S. in Science related field (or equivalent)
• Minimum of 3 years of drug/biotech experience
• Minimum of 5 years of quality auditing in GLP, GMP and/or ICH/GCP environment
• Knowledge and experience with all aspects of Quality System Management, lot disposition, deviation and investigations, CMC participation, training, and auditing
• Thorough working knowledge of regulated GMP systems as well as FDA, EMEA, ICH and JP regulations
• Ability to effectively communicate verbally and in writing
• Collaborative working style (internal and external) with supervisory experience
• Flexible in working with associates from all departments and organizational levels, including external partners, while meeting commitments
• Experience with requirements relating to the development of antibody-based bio therapeutics pharmaceutical development processes
• Problem-solving and decision-making skills, as well as the ability to prioritize and successfully manage complex and competing projects
• Ability to travel up to 25%
Source: Job Diva – Job Listing
The IT Technical lead will be responsible for working closely with IT Business partners, Business analysts, development and testing teams to implement required updates to datamarts and Qlikview/Qliksense dashboards, in preparation for the California Consumer Privacy Act on Jan 1st 2020. This is a critical, aggressive program that will require the technical lead to design and deliver system updates across multiple systems in their function.
Skills
Education
Source: Job Diva – Job Listing
The IT Technical lead will be responsible for working closely with IT Business partners, Business analysts, development and testing teams to implement required system changes, in preparation for the California Consumer Privacy Act on Jan 1st 2020. This is a critical, aggressive program that will require the technical lead to design and deliver system updates across multiple systems in their function.
Skills
Education
Source: Job Diva – Job Listing
The IT Business Systems Analyst will be responsible for working closely with partners from US medical affairs, Commercial and Employee experience/user services and IT, to assess and document system and process updates required to comply with the California Consumer Privacy Act.
Skills
Education
Source: Job Diva – Job Listing
Receiving, shipping, storing and tracking biological samples using a Biological Sample Management Database.
Assessing sample shipments upon receipt; maintaining and tracking inventory (formalin fixed paraffin embedded blocks, formalin fixed tissue in specimen containers, OCT embedded frozen tissue, flash frozen tissue, serum and other biological samples)
Will be responsible for hands on inventory management of stained and unstained microscope slides
Whole slide scanning
Skills: relevant experience, computer skills, ability to work in a fast paced enviroment. Experience working with databases, exceptional attention to detail
1+ years of experience handling biological specimens
Excellent written and verbal communication
Ability to talk to customers, managers and technical personnel with credibility
Demonstrated leadership skills; ability to work across organizational lines
Customer service or histology background
Organized and detail-oriented
Exceptional problem solving skills with the ability to work independently
Experience with Microsoft Office (Word, Excel, Outlook)
Source: Job Diva – Job Listing
We are seeking an energetic and enthusiastic chromatographer who demonstrates expertise within chiral analytical and purification processes for Drug Discovery projects. The candidate's primary responsibility includes development of chiral and achiral methodologies to purify chemist's samples and investigational analytical and preparative studies of small molecules to support medicinal chemistry projects. The candidate will be expected to communicate well with medicinal chemists, Analytical Sciences, Mass Spec, NMR spectroscopists and other colleagues, in these efforts.
At least 3 years of relevant industry experience and demonstrated success in all aspect of modern chromatography methodologies. You must have a strong understanding of organic chemistry and in-depth experience of chromatographic methods, ideally with expertise within chiral analytical and purification processes SFC and HPLC. Also expertise in data analysis/interpretation and chromatographic instrumentation, data management, software are essential. Excellent communication skills and strong interpersonal skills are required.
Source: Job Diva – Job Listing
Remote CRA II / Clinical Research Associate II with 50% travel within WA, OR, MT, UT, NV, CA
Summary:
The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country.
The Senior CRA is responsible to deliver data within timelines and required quality standard, and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
Allocation, initiation and conduct of trials
Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial
Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Company procedures
Facilitates the preparation and collection of site and country level documents
Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate
Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions
Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
Attends onboarding-, disease indication and project specific training and generalCRAtraining as required
Documents monitoring activities appropriately following Company standards
Collaborates with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed
Participates from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
Performs additional task as assigned
Skills:
Minimum of 3 years of experience in site monitoring
Excellent knowledge of the drug development process specifically clinical trial/research
Knowledge of international standards (GCP/ICH, FDA, EMEA)
Ability to manage multiple priorities and manage time efficiently.
Basic project management skills to support in CSM activities.
Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
A minimum of 50% overnight travel may be required.
Advanced communication skills, ability to influence others.
Good strategic thinking: Ability to anticipate potential issues and take appropriate actions with or without supervision.
Education:
Degree in scientific or healthcare discipline
Source: Job Diva – Job Listing
Duties:
Responsible for providing operational and program level support for several Phase I/II clinical trials under the leadership of the assigned Lead CTL. This support includes planning, set-up, maintenance and closeout of trials as applicable.
Major Accountabilities:
Support TCO Lead CTL and CTLs in group in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of related study documents (eg sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
Support CTLs by setting up and maintaining appropriate study tracking forms including:
enrollment log/trial allocations forms, site and vendor contact lists, drug shipping logs, set up and maintenance of team membership and contact lists.
Support CTLs in managing interactions with relevant functions including Drug Supply Management and local organizations (CPOs). Support CTL with all US drug supply shipping (initial and re-supply) to local CPO and all US sites to ensure timely SIV and uninterrupted patient treatment. Function as the liaison with US local depot to ensure drug delivery and relabeling occur in a timely fashion and track all drug at the central hubs.
Support CTLs in all drug tracking (central hubs, local CPOs and sites) to ensure adequate supply, monitor expiration dates and assist in relabeling as appropriate. Support CTL in tracking all batch numbers used throughout trials and assist with preparation of appropriate CSR appendices.
Provide vendor and budgets tracking and support. Manage and track US invoices for third party vendors.
Associates based in TCO Shanghai, support local CTA submission including validation of translation of protocols, amendments, ICFs, IBs etc. for TCO trials with sites in China.
Supports the Lead CTL or CTLs as the local trial leader (LTL) for US operational activities including working closely with US Clinical Operations for US study start up meetings and trial agreements in addition to all other US based study start-up activities working closely with the US Clin Ops Oncology to ensure timely Study Initiations and VDR (Verification Document Receipt) support; Updates Global ICF templates for all trials to ensure appropriate US standard language incorporated at time of package release while acting as the US liaison with Legal and the US sites through IRB approval process.
Set up and maintain eTMF tracker in CREDI for all studies. Provide support to CTL to ensure timely completion of eTMF tracker for CSR.
Support CTL in delegated aspects of trial data analysis and reporting, including attendance at all relevant study meetings (i.e. CTT and dose escalation meetings). Provide support in meeting scheduling and distribution of meeting agendas/minutes.
Assist with data monitoring such as tracking/filing of protocol deviations, generating data listings and database metrics.
Assist CTL with preparation and distribution of study tools needed at study start up and throughout trial as appropriate.
Education:
Bachelor degree or equivalent education/degree qualification in life science/healthcare required.
At least 1 year of involvement with clinical study planning, execution, reporting or publishing activities (either at a local medical organisation, investigational site, pharmaceutical company/CRO, or clinical fellowship program) preferred.
Must be proficient in Word, Excel, Outlook
Source: Job Diva – Job Listing
The scientist works in the product testing to support new product development and existing products. Duties encompass execution of testing of bulk and surface polymer properties in support of a variety of vision care projects, gauge improvement and assistance with new gauge development.
Major Accountabilities:
Performs experiments in mechanical, surface and permeability techniques of polymers and contact lenses, including sample preparation, measurement as well as associated calculations of results according to established SOPs or protocols.
Applies fundamental level analysis to provide solutions to rudimentary problems arising within the department
Responsible for instrument operation, and maintenance including troubleshooting and advanced functionality assessment.
Maintain good documentation and records for cGxP / OSHA compliance.
Effective collaboration within the team and with cross functional team members
Assists with design and development of new analytical gauges and methods as needed
Key Performance Indicators:
Careful and consistent execution of established tests and developmental methods
Key attention to details
Experience with “micro-manipulation” of small samples highly preferred.
Flexible, open and eager to learn new skills and able to transition quickly and smoothly between diverse test methods and work assignments
Data-driven application of scientific and engineering skills to provide quality data to support the project
Draws independent conclusions from data results.
Accurate interpretation of atypical / out of trend sample and prompt attention to subsequent notification process
Compliance with all regulatory, quality, and safety requirements
Source: Job Diva – Job Listing
Description:
Note: This is a 12 hr day shift position
Conducts QC analytical testing of raw materials and in process samples as required to support contact lens production.
Performs tasks according to approved SOP’s, methods, and procedures in compliance with cGMP, FDA regulations and Corporate Quality Policies.
•Conducts analysis and data collection necessary to support release of raw materials, parts, packaging components, in-process samples, and formulations
•Proper use of analytical equipment, such as GC, HPLC, UV-Vis, FTNIR, IR, Titrations, USP Monograph Testing, Viscometer, Particle Size Analyzer, GPC.
•Completes documentation relating to material analysis and enters data into database/software systems; such as MES, SAP or LIMS.
•Provides technical input on observed issues with methods, procedures, and practices.
•Conducts lab/ nonconformance investigations, and special projects as assigned.
•Completes and participates in training activities which maintain or improve laboratory skill sets and practices.
•Defines and works on resolving technical problems within defined scope and within level of expertise.
•Actively works in a team environment and participates in natural work groups and increases productivity.
Assists with method implementation and/or method transfer and equipment qualification activities as assigned
.
Qualification and Required Skills:
Bachelor of Science (BS) degree in Chemistry from an accredited college or university (no biology degrees)
•Minimum of 2-3 years of experience working in an analytical laboratory in a regulated industry
•Operating at least two of the following analytical instruments or systems: GC, HPLC, UV-Vis, FTNIR, IR, Titrations, USP Monograph Testing, Viscometer, Particle Size Analyzer, GPC.
•Excellent oral and written communication skills.
•Excellent level of written and spoken English Required.
•Highly motivated, goal orientated achiever with ability to prioritize and organize own work semi-independently.
•Proficiency in MS Word and MS Excel and demonstrated application of problem solving/trouble shooting tools .
Source: Job Diva – Job Listing
Description: The individual in the position will be a key contributor and in partnership with operational stakeholders participate in the entire development life-cycle, develop and implement from proof-of-concept to release innovative solutions based on a variety of software platform solutions (e.g., SmartSheet, Spotfire, Tableau, R-Shiny). In addition, the individual will effectively capture and help support end-users and maintain key business operational data (e.g., KPIs related to financials, contracts, vendors).
Responsibilities:
¿ Participate in the entire development and implementation of solutions based on Smartsheet
¿ Implement where applicable features and improve preexisting tools
¿ Build and maintain integrations with other technology platforms: Smartsheets, Google, Microsoft, Tableau, Spotfire and others
¿ Participate in all phases of quality built/checks and resolution of technology/process issues
¿ Captures and maintains operational data related to but not limited to resource management, financials, contracts, vendors
¿ Identifies areas of best practice and process improvements.
¿ Participates in cross-functional initiatives and programs as assigned.
¿ May lead or be a representative on functional groups goals, initiatives and work-streams.
Qualifications & Requirements:
¿ 5+ years of software/solution development and implementation experience in order of importance Smartsheet, Spotfire, Tableau, and R-Shiny.
¿ Familiarity with relational databases.
¿ Experience implementing responsive designs for mobile, tablet, and desktop browsers.
¿ Strong organizational skills with attention to details.
¿ Proven track record of independently managing multiple competing projects simultaneously .
¿ Ability to prioritize and apply sound decision-making with limited information.
¿ Excellent communication skills with an ability to effectively coordinate/influence cross-functional teams and stakeholders, in a geographically diverse, fluid, interactive environment.
¿ BS or MS in Computer Science, a related field, or equivalent industry experience
Source: Job Diva – Job Listing
Duties
Responsible for the coordination and execution of multiple website/mobile related projects ensuring consistency with brand strategy and business objectives
Works in partnership with internal and external teams to deliver web projects on time and budget through effective management of the project timeline, issues, risks, dependencies, and deliverables
Has a good understanding of web best practices including user experience, SEO, A/B testing, and website performance optimization
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
Skills
Deep familiarity with service production marketing technology, processes, and tools
Experience with website management tools like AEM, Google/Adobe Analytics, JIRA, Confluence is highly desirable
Digital marketing 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
Experience in the software, Client, pharmaceutical or biotech industry preferred
Source: Job Diva – Job Listing
Sr. SAS Programmer Analyst
Perform SAS programming to provide complex data review listings/reports to support different functional groups for Oncology trials.
Program data review checks as necessary to facilitate data cleaning activities.
Design standard programs and macros using study metadata.
Design and develop SAS macros, applications, and other tools to expedite SAS programming activities to support different areas of Clinical data review.
Develop standard SAS utility macros for developing standard programs.
Develop and maintain the programs including testing and organizing the SAS datasets, SAS programs and related documentation.
Ensure all programming activities and processes are performed following standard operating procedures and good programming practices.
Participate in system validation, customization, and integration of new tools and technologies.
Qualifications:
Strong SAS programming skills required in Windows & UNIX environment with proficiency in SAS/Base, SAS Macros, SAS/Graph, SAS/SQL.
Experience in writing SAS tools and developing generic SAS programs for clinical studies
Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide, SAS Data Integration Studio, SAS Studio is a plus
Knowledge of program development in JReview is a plus.
Knowledge in developing SDTM specifications, programs, and validation are desirable.
Good understanding of relational databases such as ORACLE, Knowledge of the EDC system, InForm, and underlying data structure is desirable.
Good understanding of system development life cycles, GCP, and related regulatory guidelines.
7-10 years of experience in programming with clinical trial data and preparing programming and test documentation.
Experience with all clinical phases I, II, III and IV of oncology trails is desirable.
Good understanding of Recist, mRecist, irRecist and Rano criteria.
Extensive experience of handling external data, such as lab data, PK,Tumor,Biomarker,Imaging etc.
Good understanding of standards specific to clinical trials such as CDISC, SDTM, MedDRA, WHODRUG.
Good understanding of Regulatory requirements for submissions to FDA, PMDA and EMA.
Strong problem solving skills
Able to work independently and a team player, good organizational and time management skills.
Excellent communication skills & capable of communicating technical concepts
Excellent organizational skills, demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.
NOTE: We need someone experienced in writing complex macros and generic programs and related experience.
Source: Job Diva – Job Listing
The Drug Safety System Specialist is a support role for the Drug Safety Systems team that will focus on tasks related to the management and business utilization of the drug safety database, drug safety data and reports. Responsibilities include:
• Business support activities related to the safety database including understanding and documenting business requirements and configuration management.
• Managing and facilitating the process for generation of aggregate safety reports to ensure compliance with global regulatory requirements.
• Collaborating with IT, internal key stakeholders and external business partners to coordinate the appropriate deliverables for aggregate safety reports, drug safety business requirements and data requests.
• Recommending technical solutions and reports to Drug Safety colleagues by analyzing the needs of the business and aligning with available tools and data
Demonstrated proficiency and experience:
• Bachelor's degree required
• Ability to successfully lead meetings comprised of internal & external resources (up to 35 attendees) including executive level attendees
• Proficient in interpreting regulatory requirements and effectively conveying meaning to educate and resolve discrepancies amongst a diverse audience
• Business and data analysis skills in pharmaceutical or related space
• Business requirements gathering and specification development
• Creating test scenarios and executing test protocols
• Strong understanding of Microsoft Office tools including Word, Excel, Power Point and Visio; Excel skills to including pivot tables and functions
• Time management skills with ability to handle time sensitive deadlines and quickly pivot when unexpected events or changes present themselves
• Excellent communication (written and oral) and collaboration with technical and non-technical audiences
• 2+ years in in the pharmaceutical industry preferably in one of the following areas: Drug Safety, Clinical Operations, or Regulatory Affairs
Desired proficiency and experience:
• Knowledge of global aggregate report regulations and guidance (e.g. PSUR/PBRER, DSUR, PADER)
• Direct experience with systems and data that support Drug Safety (e.g., Argus, ARISg)
• SQL Skills
• Report development using business intelligence tools with structured data sets
Source: Job Diva – Job Listing
The Sr. IT Systems Analyst is a member of the IT Business and Systems Analysis Center of Excellence (CoE) and is responsible for deploying, configuring, and implementing technology systems at ***; acting as subject matter expert where appropriate; and providing ongoing process and enhancement support post-implementation.
• Responsible for the implementation and ongoing support of IT applications, including on-prem server-based applications, laboratory systems, and SaaS solutions.
• Complete upgrades and enhancements to existing applications
• Requisition application servers and assist in application installation
• Identify gaps between business needs and technical capabilities; work to find innovative solutions that meet business objectives or create new business opportunities
• Create user documentation and train personnel on applications/reports/solutions, as required
• Represent the needs of our customers to the solution vendor(s)
• Author and refine system support processes, flow diagrams, configurations, and interdependencies
• Develop effective working relationships with our internal customers and vendors during project meetings, on-site visits and conference calls
• Assists our internal customers in developing working scenarios for testing
• Participate in GxP validation/qualification of systems including writing, reviewing and executing validation protocols when assigned GxP systems
• Communicate support issues, solutions and progress to management
• 8+ years experience supporting and implementing large scale IT solutions
• Bachelors Degree or higher in Business, Computer Science, Engineering or related discipline, or equivalent work experience
• Familiarity with implementing, integrating, and supporting laboratory systems
• Demonstrated technical understanding of application architecture to include application servers, web servers, configuration files, relational databases, SQL and reporting applications
• Experience with basic scripting, command line execution, development of batch files
• Proven knowledge of IT solutions and application management through various product cycles and business environments
• Ability to prioritize and quickly adapt to changing situations
• Excellent communication skills, including the ability to interface and influence at multiple organization levels
• Strong interpersonal skills, with a high degree of self-motivation and ability to work independently
Source: Job Diva – Job Listing
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