Latitude, Inc. Upstream Manufacturing Manager in Rockville, Maryland
The primary role of this position is to provide technical support for both government contracts and commercial projects as related to GMP upstream production tasks.
This position requires the hands-on experience in the GMP laboratories related to cell culture techniques. The candidate must follow strict planning and coordination of work and timing/rotations for the assigned tasks. The candidate must be proficient in cell culture techniques, systems and preparation of buffers and solutions and Bioreactor operations. This position also requires working in close association with Process Development team and the ability to lead the tech transfer efforts from PD to GMP manufacturing.
Knowledge and experience with Stir Tank Bioreactor system and MFCS software used for upstream 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
Comply with GMP regulations by strict adherence to departmental policies and procedures
Lead a team of supervisors and 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 that all processing equipment and instruments are identified and maintained as per internal approved procedures.
Must have strong experience in the transfer and production of GMP candidates
Knowledge of cell culture techniques, process platforms, and production equipment operations
Experience in a GMP environment required.
Proven supervisory and leadership experience involving a minimum 2-3 staff members.
Ability to perform statistical analyses and presentation of data.