Perform routine analysis and testing in a GMP environment May participate in qualification/verification of assays Assay and documentation review and report writing Maintain personal training records. Attend all required training. May be responsible to provide training as applicable. Regular and reliable attendance on a full time basis [or in accordance with posted schedul

Develops, optimizes, qualifies and/or validates analytical methods using HPLC, LCMS, cIEF, CE SDS, UV and particulate matter quantitation and characterization assays (e.g. HIAC, MFI, DLS and HOUND). Coordinates and executes analytical method transfers between Clients and Aji Bio Pharma. Provides advanced technical problem solving without supervision in method development,

Follows method standard operating procedures (SOPs) and conducts analytical method transfer. Develops, qualifies, and validates analytical methods with minimal supervision. Investigates, creates, and develops new methods and technologies for project advancement under limited supervision. Analyzes in process, release and stability samples by battery of analytical methods a

Performs cGMP documentation/data review (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records. QMS process support for change controls and quality investigations. Performs AQL inspection of final filled product. Performs area line clearance operations in support of manufacturing operations. Provides QA oversight and performs real ti

Interacts with clients to ensure successful technical transfer and integration of lyophilization processes into Aji Bio Pharma's manufacturing operations. Provides technical and theoretical support to manufacturing staff within area of specialty. Writes and reviews SOPs, compliance, change controls, risk assessments and other technical and quality related documentation. E

Documentation Preparation (Protocol and Report Generation). Protocol Execution. Training, database entry, and audit support. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices Embodies Aji Bio Pharma's cultural values and al

Maintain process equipment in use ready state. Major equipment includes aseptic fillers and isolators, vial washing machines, ovens, and autoclaves. Monitor, respond to, and correct issues generating process, process support, and laboratory equipment alarms. Complete CMMS entries and required training activities. Travel between facilities to support all functional areas.

Design and implement reliability programs to improve uptime. Participate in design and installation stage of projects for new assets and modification of existing assets. Evaluate existing systems for continuous improvement opportunities. Provide technical support to manufacturing, maintenance and other technical personnel. Provide in depth technical review of all document

Manages the documentation/data review in support of manufacturing operations (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records) with junior staff. Designated subject matter expert during AQL inspection Assists in real time review of documents on the manufacturing floor Assists in the review and approval of executed and non execu

Conducts and reviews routine analysis and testing of samples under general supervision and may focus analysis and testing in a particular QC arena. Performs releases testing assays for in process, final product, raw materials, stability and other routine samples. Adheres to cGMP requirements and SOP's. Compiles data for documentation of test procedures. Responsible for st

Performs environmental monitoring within the microbiology laboratory, manufacturing suites, clean rooms, and drug product operations. Performs enumeration and gram staining of bacterial colonies. Sampling and analysis of the utilities including water, steam, and compressed gasses. Support process qualification of water, HVAC, and other systems. Must gown qualify and exemp

Provides HR guidance to employees and managers with regard to career development, recruiting, performance management, compensation, training, LOA, company policies, etc. Partners with hiring managers by participating in interviewing leadership candidates. Recommends compensation offers for new hires. Serve as subject matter expert on employee relations; conducting investi

Why join Ajinomoto Bio Pharma? Our mission is to help improve the health of humankind. We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which th

Train in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility. Train on required SOP's and execute training curriculum. Prepare materials needed for aseptic operations. Performs various routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations. Accurately documents data and complet

Contributes to customer audit program, including scheduling audits, hosting audits, communicating and coordinating with internal SMEs, responding to audit findings, and tracking completion of corrective actions. Contributes to internal audit program, including generating an audit schedule, conducting audits, writing audit reports, and evaluating responses to audit observa