Senior Regulatory Affairs Associate Experience Biologic CMC 5+ years of experience Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to new application, post approval variations Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appr

Under departmental supervision, the Medical Writer will research, create, edit, and coordinate the production of PBRER/PSUR for submission to regulatory authorities. The Medical Writer would serve as the primary client contact. The Medical Writer must have minimum 3 years of experience in authoring or supporting PBRER/PSUR Key Accountabilities Accountability Supporting Ac

The Senior Manager, Quality Control Analytical will report to the Director of the Quality Control Analytical team at the Resilience Philadelphia site. This motivated and organized individual with strong people skills will provide supervision and technical expertise to the QC Analytical laboratory while maintaining open communication channels to meet the needs of the organ

Environmental Scientist / Wetland Scientist Natural Resources York, PA ID 20772 Full Time/Regular Johnson, Mirmiran & Thompson is a dynamic, 100% employee owned consulting firm of more than 2,000 professionals that provides a full range of multi disciplined engineering, architecture, information technology, and related services to public agencies and private clients throu

Provide subject matter expertise (SME) in Biologics Formulation and DP process development including lyophilized presentation development. Author and review CMC modules of IND and BLA filings Support tech transfer of biologics drug product processes to commercial scale contract manufacturing organizations (CMOs) Serve as Person in Plant (PiP) during batch production to ac

Write and edit lean clinical regulatory documents companywide for sense, clarity, accuracy. Provide writing support for a wide range of documents, including investigator's brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs. Work with the lead writer to create, manage and communicate the document timeline to ensure all revie

As a Quality Control Team Leader at Purolite, an Ecolab Company, you will be responsible for the following Independent testing of raw material, in process, finish product and packaging materials testing. Daily checks balances, refrigerators, stability chambers. Physical testing, pH, Conductivity, KF (Karl Fisher), Particle Size, Moisture Analyzer. Instrument analysis such

Instructional Designer Job Locations US PA Worcester ID 2024 10487 # of Openings 1 Category Human Resources Responsibilities Under limited supervision, this exempt position is responsible for working with subject matter experts to design, develop, and implement effective learning experiences utilizing innovative solutions that support our educational needs. The Instructio

Senior Systems V&V Engineer (Smith & Nephew, Inc., Pittsburgh, PA) Manage and own all aspects of system verification for programs within a work stream, including determining creation, management and ownership of testing strategy, integration testing, robustness testing strategies, and defect management. Participate in requirements discussions and provide input to testabil

Leads multidisciplinary teams in delivering on the design, execution, strategy and management of various development, clinical pharmacology and regulatory engagements, from early translation to late development. Works collaboratively with and leads Certara team members and clients to develop clinical pharmacology and quantitative program strategies that are fit for purpos

Job Type Regular Research Project Coordinator for Education & Labor RAND Research Administrative Operations has an exciting opportunity for a Research Project Coordinator (PC) who will serve in a role as Quality Assurance Coordinator (QAC) for the Education and Labor division (50%), along with other similar project management activities that will be determined at time of

The successful candidate will contribute to several JJR&R Lab projects, including an evaluation of a citywide effort to increase access to criminal record clearing, a multi county evaluation of juvenile diversion reforms, and a large scale randomized controlled trial (RCT) within the School District of Philadelphia. The successful Assistant Research Professor candidate wi

All activities below will be performed independently and then reviewed by the mentors for discussion and revisions. Develop short term (6 months) and longer term (1 2 years) career goals. Develop important and novel research questions within the context of the research program. Analyze neuroimaging and epidemiological data Interpret results. Write manuscripts based on res

Training Lead, ERP General Resume Submission Pittsburgh, PA ID 2800 Full Time/Regular Headquartered in Pittsburgh, Pennsylvania, at Chromalox a Spirax Sarco Engineering company, we build advanced thermal technologies for the world's most challenging industrial heating applications. We do it better and have been doing it longer than anyone else. Chromalox started with an i

Lead collaboration with business stakeholders and implementation partners to configure, build, and deploy the MES systems. Lead cross functional technical team to ensure a successful implementation of MES systems and technology. Lead teams of business units, application developers, security, and infrastructure engineering to troubleshoot application integrations that supp