Senior Research Scientist Quality Assurance GMP Process

University Of Texas Southwestern Medical Center   •  

Dallas, TX

Industry: Hospitals & Medical Centers


5 - 7 years

Posted 71 days ago

This job is no longer available.

This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information


Salary Negotiable

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.

Job Summary

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.

Job Duties

- 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.

Job Number: 91820