Job Search Results for therapy

Insight Global is seeking a Combination Device Development Project Manager to join a pharmaceutical client's Device Product & Process Development (DPPD) Team. This team designs, develops, and... More commercializes novel biologic/drug/vaccine-device-enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of the device constituent of our company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection. Duties: *Collaborate with cross functional team members and support drug-device combination product program technical and engineering leads to develop and maintain project timelines. *Track project milestones, deliverables, and risks; prepare reports/dashboards/risk register that summarize key progress and issues on development programs across different device project teams, including preparation and presentation of routine updates to management. *Support teams through the effective execution of management-approved strategic plans for assigned projects; this includes ensuring key milestones are tracked, risk management plans are fully developed, deliverables/decisions are agreed upon and adhered to, communications within and external to the team are clear and effective when significant program deviations are encountered. *Support teams through scenario planning to evaluate the pros and cons of proposed scenarios, identify constraints and trade-offs between different scenarios, and provide new/updated timelines as needed. *Ensure project data are accurately reported in databases and understood by development team members and governance forums, including information used to derive costs, schedule, resources, and any other data pertinent to creation and management of project plans. *Ensure that team meetings have structure and clear purposes and goals; facilitate meetings, issue meeting minutes and clearly communicate decisions and action items to team members and relevant parties outside of the team. *Collaborate with project managers of the Development and Commercial Team and other working group and sub-team leads to integrate their timelines with the device development timeline. *Provide input/direction on program timeline needs to internal and external sites and integrate timelines from suppliers and sites into the device development timeline. *Develop and manage material demand schedule and interface with external partners & sites to ensure the availability of materials needed to support product development and commercial capability building activities.This is a hybrid role, required 2-3 days a week on-site in either Rahway, NJ or West Point, PA.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

The QC CRS Analyst is responsible for conducting biochemical and testing of raw material, in-process, final product release and characterization samples, including CAR-T. They are responsible for... More ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 -- 10 other Analysts within a functional Clinical Release and Stability Laboratory and report to the Senior QC Supervisor.Key Responsibilities:-Conduct analytical biological testing of clinical and commercial drug product/drug substance samples-Perform peer reviews and approvals of laboratory data-Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory data-Support of New Product Initiatives (NPI) including owning a project and perform project management functions with limited to no coaching from supervision/management -Perform Instrument Calibration and Preventative Maintenance-Update CRS-owned documents using the Document Management System (DMS) -Order/receive supplies and manage inventory-Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities-Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight-Act as a peer subject matter expert in assessing talent by participating in panel interviews for job-Complete invalid assay and general laboratory investigation records-Complete corrective and preventative actions (CAPA) as assigned-Assist in the execution of internal auditsWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

This person will work onsite in DHS processing centers, providing trauma-informed care, crisis intervention, and professional guidance to support children in federal custody. You will collaborate... More with facility staff, assess child well-being, and contribute to policy improvements that enhance child protection services.- 12 hour shifts, no on call hours (night or day shift is negotiable)- do the assessment with children (20 minutes), then documentation after each assessment (20-30 minutes) - on days that are slower, will do presentations for the CBP officersWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less

Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh/Dispense. Employee will work seamlessly across... More all areas and will be an SME for multiple areas. Leads new products introductions (NPIs) into CCTC with support from biological development (BD) and tech transfer teams (MSAT). Ensures all activities are tracked and performed to schedule. Actively collaborates with BD and MSAT to ensure cross functional alignment with platform process, equipment, raw materials and/or automation. Manufactures products in various phases of product life cycles from clinical thru launch.Clearly understands, communicates, and manages complexity in terms of documentation, sample handling, automation and cGMPs etc. for different phases of product life cycle. Manages, handles and troubleshoots single use technology (SUT) from end to end in manufacturing process. Monitors and controls all aspects of manufacturing processes using data trending and /or statistical process control. Works cross functionally to ensure process is controlled and issues are escalated and investigated.We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form. The EEOC "Know Your Rights" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Less