cGxPServe

Roles & Responsibilities: We are looking for a Lead Consultant with strong expertise in Laboratory Information Management Systems (LIMS) to lead and support LIMS functional consulting engagements. The ideal candidate should have significant handson experience in LIMS implementation c More...

Responsibilities: We are seeking a skilled Clinical Data Management Lead to oversee the execution of clinical trials. This role will be responsible for ensuring highquality data collection review and delivery within scope on time and with precision. Lead clinical trial project teams More...

Responsibilities: Experience in green or brown field GMP MFG facility startup including process systems automation utilities facilities and operations. Strong technical background in Process and Manufacturing engineering manufacturing operations and financial fundamentals. Strong ana More...

Responsibilities: Perform qPCR analysis including the extraction of nucleic acids from a variety of sample types and using multiple platforms. Accurately prepare and handle smallvolume samples using precision pipetting while maintaining a sterile work environment. Follow established More...

Responsibilities: Precisely follow company tissue requests study designs protocols and SOPs for the complete processing of tissuebased products with minimal supervision. Perform lab testing to demonstrate the ability of the product/device to function as intended under study director/ More...

Job description: The Process Development Tech II position exists for the processing of human porcine and fatbased tissue products. It requires clean room gowning and working in a lab setting. The Process Development Tech II serves as a subject matter expert and ensures the continuous More...

Job Description: The Environmental Monitoring (EM) Core Technician will be responsible for conducting EM tasks in support of production and aseptic processing of clinical grade products. The core tech will also be responsible for maintaining stocking and setup of clean room environmen 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 jam. Responsible for quality of product including but not limited to. Discarding ob More...

Job description: As a member of the Vantive Acute Therapies Verification and Validation engineering team you would be responsible for supporting product verification validation and compliance test activities on electrical and mechanical medical device components/systems. Your expertis 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 to. Discarding More...

Job Description: As a member of the Vantive Acute Therapies Verification and Validation engineering team you would be responsible for supporting product verification validation and compliance test activities on electrical and mechanical medical device components/systems. Your expert More...

Job description: Were seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 yea More...

Responsibilities: Leads a large clinical study or a series of related studies with minimal guidance. Represents Data Management at study management team meetings. Provides mentoring and training to lowerlevel Data Management staff assigned to his/her studies. Manage and monitor the p More...

Responsibilities: As a Senior Statistical Programmer you will develop new software applications or customize existing applications to meet specific scientific project needs. Create Client computational approaches and analytical tools as required by research goals. Consult with resea 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 delivery within budget on time. Generate validate and/or r More...

Responsibilities: The Manager Regulatory Affairs will be responsible for managing regulatory requirements and inmarket product compliance to maintain and further develop the regulatory capability of the USbased regulatory team for Alchemee (previously The Proactiv Company). The Manag More...

Job description: The Quality Engineering Manager will lead all Quality Engineering activities and incoming quality issues. Ensure all quality related systems of the plant are established and documented to provide a safe and effective product. Build sound technical and organizational More...

Job description: The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. Associates are expected to execute process recipes follow written procedures (SOPs) monitor equipment and processes perform basic laboratory tasks inc More...

Responsibilities: Actively participate on CMC development teams to plan regulatory strategies by defining pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately marketing approvals. Align CMC regulatory plan More...

Responsibilities: Provide support for all aspects of reporting including report development maintenance and documentation. Develop test debug and deploy the SAS programs. Develop statistical analysis using standard reporting ad hoc reporting and data statistics. Develop SAS and SQL q More...