Sr. GMP Specialist – Upstream PD
The role of the Sr. GMP Specialist – Upstream is to provide technical support related to GMP upstream production tasks. The candidate in this position is to take the lead in the upstream process of proteins, viral vectors and vaccines for phase 1 and 11 clinical trial material.
The main responsibilities will include but are not limited to:
- Prepare Solutions and Media, Cell Culture scale up and Bioreactor Operation
- Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.
- A strong knowledge of aseptic cell culture processes.
- Requires judgment to know when it is necessary to consult with supervisor and/or support groups.
- Operate systems that clean and sterilize tanks and filtration systems.
- Write and Revise GMP Bath Records and Standard Operating Procedures.
- Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
- Comply with safety requirements, cGMP, SOP and manufacturing documentation.
- Operate automated systems for equipment operation.
- Work within a team including interactions with support groups for planning of production activities, and receipt of material.
- Participate in technology transfer of processes from Process Development to Manufacturing.
- Occasional overtime and weekend work is required.
- Work cross functional with the downstream manufacturing group to provide resources as needed
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:
- B.S. degree in a biological or related science with a minimum of 4-5 years of Upstream Processing experience in a cGMP environment is required. Work experience may be substituted in lieu of a degree.
- Must possess clear understanding of the principles involved in various cell culture procedures, Bioreactor Operations and GMP regulations related to Biologic Manufacturing for Phase 1 and 11 clinical products. This will include safety and efficacy, as well as the yield and productivity of a process.
- The candidate must have strong and effective interpersonal skills (both written and oral) and ability to communicate effectively with QA/QC, manufacturing, facilities and other support staff.
- Task and Team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multi-task is essential.