cGxPServe

Responsibilities: This role participates in the recruitment and screening activities to ensure successful enrolment of volunteers into studies scheduled at the Phase 1 Unit. Interfaces with research participants to support efforts to determine eligibility and consenting of study part More...

Responsibilities: Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects. Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards regulatory requirements and statistical instructions. Develops and/ More...

Responsibilities: We are seeking a highly skilled and motivated Imaging Scientist at Scientist I level to join our Immunology Department. The successful candidate with a demonstrated ability to work in a matrix environment will work to develop and support small animal imaging project More...

Responsibilities: Ensure departmental or functional training plans in place and appropriate. Perform vendor qualifications regarding statistical programming functions and manage CRO programming issues and activities to ensure on time deliverables within budget. Generate validate and/ More...

Responsibilities: Serve as the main contact for service-related inquiries from recruitment managers employees and other HR team members. Ensure the complete resolution of HR requests including tracking and tracing. Offer outstanding customer service by promptly resolving queries and More...

Job Description: We are seeking experienced CQV (Commissioning Qualification and Validation) Validation Engineers to join our team for immediate contract assignments. These roles are focused on the close-out phase of CQV activities for major capital projects within a fast-paced regula More...

Responsibilities: Preparing documentation for international regulatory registrations. Preparing technical documentation to compliant to MDD and EU MDR. Defining worldwide regulatory requirements are necessary for regulatory approval of products. Participating in cross functional team More...

Roles & Responsibilities: 10 years of experience providing IT support for LIMS systems in a pharmaceutical biotech or laboratory setting. Experience with Lab Vantage LIMS is strongly preferred; experience with Lab Ware LIMS also considered. Strong understanding of laboratory processe More...

Job Description: Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry manufacturing and control (CMC) sections to ensure timely preparation of submission documents. This position will coordinate activiti More...

Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation review completion and delivery of statistical programming activities and deliverable More...

Job Description: The MES Engineer will support the implementation maintenance troubleshooting and continuous improvement of Manufacturing Execution Systems (MES) in a pharmaceutical or manufacturing environment. Responsibilities include requirements gathering testing troubleshooting s More...

Responsibilities: Develop and implement regulatory filing timelines for new and existing products in key markets such as US EU and Asia markets. Prepare and submit new global market device applications and amendments. Prepare and oversee the review of Traditional 510(k) Premarket Not More...

Responsibilities: The Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) in compliance with current Good Manufacturing Practices (cGMP). This entry-level role involves executing production processes operating and monitoring equipment performing b More...

Responsibilities Follow all company safety rules regulations and job safety analysis. Must complete plant lock out procedures and key interrupt. Fill and operate shelf carton erector and clear minor jams. Responsible for quality of product including but not limited. Discarding obviou More...

Responsibilities: Lead clinical data management activities for multiple complex studies from study startup to database lock and final reporting. Develop and manage data management timelines for multiple projects ensuring all milestones are met according to project plans. Design build More...

Responsibilities: Assessing potential suppliers via on-site Quality Cost Logistics Development Management (QCLDM) audits driving implementation of Lean BIQ & APQP continuously reviewing supplier capacity assuring production readiness through rigorous review of supplier PPAP submissio More...

Job Description: The Biochemist I am expected to work independently performing all laboratory multitask functions involved in Conjugation. The person directly reports to the immediate supervisor assisting him/her with the day-to-day laboratory operations. This position is further resp More...

Job Description: Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning /sanitizing. Monitor machine functi More...

Responsibilities: Collect enter and manage clinical trial data using electronic data capture (EDC) systems. Perform data validation and query management to ensure data quality and compliance with study protocols. Assist in the development of case report forms (CRFs) and data manageme More...

Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe support of international product registrations and related regulatory affairs activities including execution of procedures and s More...