Summary: The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.

Summary: The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.

Summary: The Quality Assurance (QA) Analyst I, under direct supervision, will be responsible for assisting with the review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements;  

JOB PURPOSE Working as part of the Fujifilm Diosynth (FDB) Enterprise Project Management Office (ePMO), the job holder will project manage and/or play a significant role in the delivery of projects which are part of the FDB Global Business Change Plan (GBCP).  This will involve key strategic and large matrix projects which include to varying degrees – global, multi-site, significant third party involvement and strategic client collaborations. The post holder will manage a portfolio of business projects, encompassing both development of systems and the delivery of business change (non-customer facing projects).  The GCBP is a rolling multi-year portfolio of projects that enable achievement of the agreed FDB Business Mid Term Plan (MTP)/Long Term Plan (LTP), required for long term business success. The delivery arm of the GCBP is the ePMO, which has been identified by the Executive Leadership Team (ELT) as a necessary foundation for the delivery of the high volume of transformation projects required in the FDB MTP/LTP. The ideal candidate will possess excellent influencing skills and have demonstrable experience in realizing and driving forward a cohesive program of work, with the ability to resolve inter-dependencies across the company. The job holder is expected to have experience of successfully leading multi-stream or multi-site projects, delivering coherent, workable and ‘bought in to’ solutions. The successful candidate will be meticulous, process-driven and have first class organizational skills.  Experience of relevant project management software applications is desirable.

Summary:   Our site is dedicated to cutting-edge areas like gene therapy and vaccine development, such as COVID-19, and continuously growing into new capabilities and fields. The work here has a start-up feel, as it is dynamic and ever-changing. The challenges we work on across end-to-end manufacturing help advance our partners’ possibilities forward.    The Director of Analytical Development is responsible for providing technical leadership in the area of virus-related vaccine and biotherapeutic technology transfer, development and in analytical methods development.  This individual will help deliver virally-based capability for current and future clients. 

Summary: The Quality Control Chemist III, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.  Following Tech-Transfer Activities, the candidate will be responsible for performing in-process, release and stability testing using the established analytical methods.

Summary The Quality Control Cell Biology III will be responsible for assisting in the qualification of test methods for in-process and final products. Be able to work under minimal supervision. Perform advanced assays requiring precise analytical skills and understanding of cell biology and immunology principles.

Summary: The Quality Control Chemist II, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.  Following Tech-Transfer Activities, the candidate will be responsible for performing release and stability testing using the established analytical methods.

Summary The Quality Control Chemist I, under general direction, will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.

Summary:  The Engineer I functions within a team based organization to actively address complex cGMP manufacturing issues.  The individual is responsible for analyzing process technologies in support of new project proposals and assist in the technical transfer into the manufacturing group.   This individual must work in a collaborative manner coordinating the transfer of biological drug processes from process development (internal or client) groups in a  CMO environment.

Summary:  The Senior Manufacturing Lead – Upstream will lead a team and work directly with a range of technologies following aseptic techniques and procedures in a cGMP environment.