cGxPServe

Roles & Responsibilities: Bachelor of Science Degree from accredited institution in Manufacturing Engineering Mechanical Engineering Industrial Engineering or a related degree. Master of Science Degree from an accredited institution in Manufacturing Engineering Mechanical Engineerin More...

Job Description: The Business/Data Analyst (Analyst) is a key contributor to the Data Analytics team. The analyst synthesizes and leverages datasets based on applied modelling and analysis of data sources with process knowledge of all the key processes in client Complete Access parti More...

Responsibilities: Lead and manage the Process Validation and Verification qualification at the plastic suppliers and other commodities across IGTD portfolio. Looking to hire somebody with Manufacturing Engineering and Design expertise to review the Specification of Product and Part r More...

Job Description: The Manufacturing Engineer I is an entry-level position responsible for supporting manufacturing engineering to ensure efficient manufacturing processes. Engineering services may include value stream management A3 problem solving process development project management More...

Responsibilities Evaluate and improve contract manufacturers processes through research design and collaboration. Develop and optimize manufacturing processes and equipment in partnership with vendors. Onboard and manage contract manufacturers ensuring regulatory compliance. Enhance More...

Job Description: The primary location for this role is Wilson NC. Design is taking place in Conshohocken PA. The design phase requires a hybrid work location of remote and onsite in Wilson as well as routine travel to Conshohocken. Once the design phase is completed this role will su More...

Responsibilities: However they will mainly fall within the areas of Pharmaceutical Biotechnology or Biologics Regulatory Affairs. This individual will prepare compile and submit CT/IND/MAA I NOA manage and implement label review translation requirements fee requirements and may suppo More...

Job description: Responsible for managing and compiling CMC sections of marketed product variations. Partner with RA CMC Project Leads and develop module 3 content and project timelines. Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections. More...

Roles & Responsibilities: Bachelors degree in engineering construction science life sciences chemical engineering biochemical engineering or related field. Minimum of five (5) years of pharma/biotech manufacturing experience in providing engineering commissioning or validation suppor More...

Responsibilities: Responsible for supporting the clinical development Neuroscience team with medical and safety monitoring. Provides medical monitoring and observation of clinical trials to ensure safety and adherence to protocol. Coordinates conducts and communicates overview of saf More...

Responsibilities: Responsible for supporting the clinical development Neuroscience team with medical and safety monitoring. Provides medical monitoring and observation of clinical trials to ensure safety and adherence to protocol. Coordinates conducts and communicates overview of saf More...

Responsibilities: Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards conventions and regulatory requirements. Perform hands on primary st More...

Responsibilities: Facilitating business data collection reporting efforts and generating periodic product PSUR / post market surveillance reports. Use local and global systems to collect various post market information such as complaint field corrective action and CAPA data. Work wit More...

Job Description: Responsible for the labeling inspecting and packaging of final container products with manual and/or automated packaging systems. Operates equipment that packages materials or products by inserting them into containers or filling containers from spouts or chutes. May More...

Responsibilities: Support the Lead Data Manager across one or more clinical studies. Reviews protocols for appropriate data capture including electronic (eCRF) design. Support CRF design review and validation of clinical database. Provide expertise and support oversight of database s More...

Responsibilities: You will critically review DM documents for accuracy and acceptability for junior level CDMs to ensure standards for data collection are applied to all studies. You will train and supervise clinical data associates. You will collaborate with all cross-function team More...

Job Description: The primary role of Manufacturing Quality function is to design implement and monitoring quality control programs. Key deliverables include but not limited to recommending changes to methods procedures and standards to improve quality of output based on analysis of d More...

Roles & Responsibilities: Primary - Review and process first part approvals for Customer New Product Development (NPD) initiatives including development review and submission of all required supporting documentation. Work with Customer facilities as required to achieve acceptable out More...

Responsibilities: Requires proficiency in Quality Assurance Procedural work and expertise in Application work by combining hands-on experimentation with scientific principles and knowledge from science/engineering education to drive foundational technical understanding and solve tech More...

Responsibilities: Cleaning and transforming raw clinical trial data from various sources to ensure accuracy and consistency for PK/PD analysis. Writing SAS code to perform descriptive analysis of PK/PD data and statistical analysis of exposure-response relationships. Data visualizati More...