Senior Upstream Specialist- (6)
- Expired: March 10, 2021. Applications are no longer accepted.
+ 5+ years of Upstream experience
+ Experience with Aseptic Technique and Cell Culture process
The personnel must maintain Aseptic process throughout the upstream process tasks.
+ Hands on experience with Aseptic Technique and Cell Culture process for Adherent and Suspension Cell lines
+ Maintain and foster an environment of safety in the laboratory by becoming trained in and adhering to the safety policies of the laboratory.
+ Comply with GMP regulations by strict adherence to departmental policies and procedures and timely accurate completion of records as needed.
+ Lead a team of 3-5 direct reports by providing guidance and supervision.
+ Foster team building and provide the necessary training to other staff members as required
+ Generate the applicable GMP documents for review and approval and validation.
+ Ensure smooth transition of projects from Process Development to Manufacturing
+ Ensure that all processing equipment and instruments are identified, and maintained as per internal approved procedures.
+ Communicate and suggest regular process improvement to management
+ Work effectively with QA/QC, manufacturing, facilities and other support staff personnel.
+ Multi-tasking ability to handle multiple projects well; and keep the team motivated.
+ Work within aggressive timelines collaboratively with cross-functional departments
+ Cross train as needed on new processes.
+ B.S. degree in a biological or related science with a minimum of 5-7 years of Upstream Processing experience in a cGMP environment is required.
+ Must possess clear understanding of the principals 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
+ The position requires the ability to lift up to 50 lbs. weight.
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