FUJIFILM DIOSYNTH BIOTECHNOLOGIES Biotechnology Process Engineer/Scientist in COLLEGE STATION, Texas

Summary: The Biotechnology Process Engineer/Scientist, 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. Essential Functions: Applies scientific and cGMP manufacturing expertise to address issues in the technology transfer and implementation of client specified manufacturing processes for biologics including viral based products and vaccines. Serves on cross-functional technology transfer teams that include client technical staff and internal process development and manufacturing teams. Identification of single-use process equipment of appropriate scale and quality for the cGMP execution of client specified manufacturing processes. Assists in the preparation of user requirements, vendor quotes, and purchasing of equipment. Provides technical information for the preparation of change controls, protocols, and new user training for the process equipment. Reviews process requirements for GMP manufacturing through process specifications and batch records. Identifies raw materials and consumables of appropriate quality for the cGMP execution of client specified manufacturing processes; assists in the preparation of material specifications, vendor quotes, and the purchase of the materials. Responds to client and/or internal staff questions or concerns about cGMP equipment, materials, and procedures. Uses key and critical process parameters and their associated critical quality attributes to assist in the preparation of product specifications. Provides data analysis from each manufacturing run that will be included in intermediate and final project summary reports and other team deliverables. Contributes to and ensures the achievement of goals and tech transfer milestones on multiple projects without delay in schedule or excessive use of resources. Perform all other duties as assigned. Required Knowledge/Technical Expertise Individual will have knowledge/expertise relevant to: Working within cGMP environments in relation to biologics and vaccine manufacturing. Hands on process development or manufacturing experience with clinical scale projects. Experience with single-use manufacturing equipment and materials. Understanding and experience in aseptic techniques. Document writing including protocols, batch records, and SOPs and summary reports. Experience with Microsoft Excel, Word, and PowerPoint. Other Abilities: Build credibility by performing high quality work. Expand the technical capabilities of teams using academic and hands-on experience. Trains other members of the team with respect to the day-to-day goals and activities by imparting their expertise to the group. Effectively communicates results of own work through meetings, presentations, discussions and documentation with some input from supervisor. Minimum supervision required on day-to-day activities and accomplished tasks. Ability to work in a team oriented environment is essential, as this person will work closely with other team members and clients. Self-motivated and capable of demonstrating technical competence. Excellent interpersonal communication skills and ability to influence and collaborate in a team environment. Analytical and excellent problem-solving skills. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential func