AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
The Manufacturing Supervisor (Downstream) is responsible for overseeing staff in the execution of production processes for GMP manufacturing operations
Responsible for the daily organization of work flow; delegate responsibilities for shift operations as needed
Responsible for completing the required documentation including, but not limited to, deviation reports, change control, product change over and maintenance task
Responsible for the review and approval of executed manufacturing MBRs Monitor staff during operations as described in standard operating procedures and batch records
Ensure staff complies with all company/regulatory quality systems, safety procedures, and SOPs
Review and ensure errors during manufacturing operations are corrected
Establish priorities, set clear expectations, and demonstrate high standards of work practices
Train, coach, and mentor manufacturing team on manufacturing functions.
Promote a safe work environment.
KNOWLEDGE, SKILLS & ABILITIES:
Must be able to communicate clearly, both verbal and written, in English
Demonstrated expertise using Microsoft Excel and Word
Technical writing skills preferred
Strong organization skills with the ability to prioritize tasks for staff
Ability to work hours necessary to support production and / or maintenance activities.
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to work in loud noise environments
BS in Biochemistry, Biology, Chemistry or related field desired
8+ years GMP operations experience, including 3+ years leading a team/group
Experience in one or more of the following Bioprocess operations (filtration, purification, cell culture or recovery)
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE
CMC Icos Biologics Inc.