Associate Director, Process Sciences
Associate Director, Process Sciences, (College Station, TX) Optimize & supp operational excellence & lean activities to supp tech transfer of projs from Process Dvlpmnt to Manuf for cGMP manuf of therapeutics & vaccines. Lead activities fr Cell & Gene Therapy & Saturn (Monoclonal Antibody) manuf ops in prep for & execution of Process Validation. Analyze process tech, id equipment for manufacturing scale projs, & provide tech sales proposal supp fr new projs. Mng engineers & techn staff. Oversee design, planning, & interpretation data frm Process Characterization experiments. Ensure safe & quality system compliant ops of new process thru execution of tech risk assessments & implementation of mitigation to reduce risk to acceptable levels. Provide engg guidance & oversight fr system & equip design, selection, purchasing, receipt, commissioning, specs, & modifications. Review, revise, & approve SOPs & work instructions fr cGMP manufacturing of commercial products. Reqt's: Master's or equiv in Chem, Bio, Life Sci, Biotech, Chem Eng, Process Eng, or rltd fld & 2 yrs exp in position offered or rltd, incl 2 yrs exp: w/ Perf Mngmt & Project Mngmt of team responsible for multiple Tech Transfer projects: Transfer Doc Review & gap Anlys, Equip Selection, Process Specification, BOM Generation, Batch Documentation generation, Health & Safety Assessments & PPA; Sales & Op Planning & Tracking: Mngmt of Bus Milestones thru use of Tier Reporting; cGMP & QA concepts: Root Cause Anlys using LSS tools fr investigation of Deviations & implementation CAPAs; Process Characterization: Appl FMEA Risk Assessment, DOE & Statistical Anlys of data; Validation: Spec of Processing Equip thru URS/FS/DQ & Validation thru IQ/OQ/PQ; Design & implementation of single use processing sols for cGMP manuf.
Resume to FUJIFILM Diosynth Biotechnologies Texas, LLC to kathy.schroeder@fujifilm.com & ref title in subject.