T2: Technical Associate of Biotherapeutics Drug Product Manufacturing is a GMP Drug Product manufacturing position responsible for the execution and review of batch records following site approved standard operating procedures (SOP) inside the Chapel Hill Manufacturing Facility. This position will maintain and prepare equipment, revise SOPs, Train personnel, formulate drug products, aseptically fill and inspect drug products manufactured according to approved SOPs and batch records.
- Manages own time and professional development; accountable for own results. Begins to prioritize own workflow.
- Adheres to Company safety procedures and guidelines by practicing and promoting safe work habits.
- Maintains areas and manufacturing documentation in compliance with SOPs, GLPs, and cGMPs.
- Identifies and solves moderately complex problems. Makes decisions that require choosing from limited options. May seek the input and assistance of others.
- Develops and revises GLP and GMP SOPs and master production records and solution batch records to ensure their compliance with cGMP’s.
- Has solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for position. Expanding technical skills and range of operational knowledge.
- Strictly adheres to SOPs, GLP, and cGMP regulations, including GMP batch records, and accurately completes documentation associated with preclinical and clinical manufacturing.
- Manufactures research, pre-clinical (GLP) and clinical (GMP) grade rAAV vectors utilizing shaker flasks, WAVE bioreactors and stir tank bioreactors along with depth filtration, centrifugation, column chromatography, and TFF.
- Performs routine maintenance and troubleshooting of equipment and processes.
- Excellent oral and written communication skills; authoring of SOPs
- Comfortable with training new operators
- Good working knowledge of GLPs and regulatory compliance requirements in a cGMP environment.
- Experience working with computerized system (bioreactors, chromatography systems, filtration units). Understandings of scientific principles in order to problem solve and troubleshoot test results.
- Ability to think critically and demonstrate troubleshooting and problem solving skills.
- The successful candidate will possess strong interpersonal, teamwork, and collaboration skills.
- In addition, possesses strong workload planning skills, organization, and attention to detail, and follow through.
- Ability to prioritize and multi-task concurrent project demands.
- Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel.
Vacancy Type: Full Time
Job Location: Durham, NC, US
Application Deadline: N/A