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

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.