Responsibilities. Follow all company safety rules, regulations and job safety analysis. Must complete plant lock out procedures and key interrut. Fill and operate shelf carton erector and clear minor jam. Responsible for quality of product including but not limited to. Discarding obviously defective packages, removing and saving syringes. Checking packaging for correct countChecking for damage to syringe Inserting brochures as required. Palletizi...
Responsibilities. Involved in the programming activities on multiple projects/ studies across various therapeutic areas, both internally and externally by CROs. Creates and reviews annotated CRF to SDTM datasets. Provides support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company' s strategic objectives. Functions as a positive role model for setting ...
Roles & Responsibilities. Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout, Modeling, and Documentation. Equipment and Tooling Development. Process Development and Characterization. Test Method Development and Validation. Developing / Updating MPIs. Supplier Development and Component Engineering. Manufacturing Engineering Support / Engineering Documentation. Update work instructions to match the p...
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 lower-level Data Management staff assigned to his/her studies Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies. build effective relationships with CRO / vendor counterparts. Reviews protocols ...
Job Summary. We are seeking a detail-oriented and technically skilled Veeva QMS Support Specialist to provide end-user support, configuration assistance, and continuous improvement for our Veeva Quality Management System (QMS). This role serves as a bridge between Quality, IT, and end users, ensuring smooth implementation and operation of Veeva QMS modules including Change Control, Deviations (QE), Continuous Improvement/CAPA. Responsibilities. S...
Responsibilities. Proven leadership in testing/validation for medium to large system implementations, ensuring GxP compliance and quality delivery. Extensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomes. Proficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoint) for project management and reporting. Expertise in Client ALM for managing testing cycles, with broad technica...
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, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding o...
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 plans with cross-functional development and manufacturing teams. Execute regulatory strategies: track and manage progress within defined timelines. Articulate complex CMC...
Job Summary. We are seeking a skilled and motivated .NET Developer to join our dynamic team. The ideal candidate will have a strong background in software development, with experience in designing, developing, and maintaining applications using the .NET. This role requires a professional level of expertise and involves collaborating with cross-functional teams to deliver high-quality software solutions across multiple projects. Responsibilities. ...
Roles & Responsibilities. Responsible for the dispensing of raw materials liquids and powders (hazardous and non-hazardous), acids/bases, under cGMP conditions to support the manufacture of therapeutic proteins (API). Individual will be required to perform and monitor all dispensing processes and weighs, including liquid, powder (hazardous and non-hazardous), acids and bases. All processes will be completed per cGMP guidelines to support the manu...
Job Description. The Biologics Drug Product Development team develops antibody drug conjugates (Client) and other biologics by state-of-the-art formulation and analytical technologies. We create valuable intellectual property through new formulation compositions, cost effective manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content. We are looking for a highly motivated person to support Devel...
Job Description. Uses scientific education and analytical chemistry experience to perform simple to moderately complex laboratory testing within a good manufacturing practices laboratory to generate results. Interprets data output to determine conformance to specifications. Acts as a team member in the API/ Raw Material/ In-Process/Drug Product testing laboratories. Responsibilities. Independently performs and verifies a multitude of laboratory t...
