Senior Upstream Specialist- (6)

Main Focus-

+ GMP

+ 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.

Job Requirements

+ 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.