Senior Research Scientist Quality Assurance GMP Process
Job Number: 91820
Category: Research & Laboratory
Location: 5323 Harry Hines Blvd, Dallas, TX
Department: 423016 - PD-Neurology
Full/Part Time/PRN: Day Job
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information
Experience and Education
Ph.D. degree with major coursework in field of assignment and six (6) years research experience in field of assignment, including at least one (1) year at level of Research Scientist or equivalent.
Master's degree with major coursework in field of assignment and nine (9) years research experience in field of assignment, including at least two (2) years at level of Research Scientist or equivalent.
Candidate would act as Quality and Compliance SME for clinical manufacturing operations; development and approval of cGMP documents including, but not limited to: SOPs, batch records, protocols and specifications; qualifications validations, and revalidations of facilities, equipment and processes related to clinical manufacturing; ensures facilities are suitable for products manufactured; internal audits of clinical operations on a timely basis; follow up CAPAs process; tracking of KPIs, and Quality Risk Management program for Clinical Operations; must be able to utilize experience, established industry practices and customer expectations to temper decisions under consideration.
- Plans, organizes, coordinates, directs and personally participates in major medical or scientific research projects, including development and implementation of research protocols. Selects key research personnel; determines specific goals or objectives to be attained; assigns and reviews work of subordinates.
- Reviews and analyzes resulting research data, revises techniques or approaches to work problems as indicated as necessary by research data. Compiles, writes and submits project results to principal investigator or department chairman.
- Prepares or assists in preparation of research papers, reports and abstracts for publication as one of co-authors.
- Designs, develops or adapts equipment used in experiments or research to obtain desired results.
- Plans and supervises training of technicians and other laboratory personnel with respect to proper laboratory techniques, use of laboratory equipment, and safety procedures.
- Confers with industrial, governmental or other groups concerning progress or results of research project.
- Supervises large group of employees engaged in performance of technical and professional work, which varies from routine to complex laboratory work tasks.
- Performs other duties as assigned.
UTSouthwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; sex; including sexual harassment; age; disability; genetic information; citizenship status; and protected veteran status. In addition, it is UTSouthwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.