Latitude, Inc. Senior Upstream Specialist- (6) in Rockville, Maryland
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.