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 Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes.
Executes bioprocess operations successfully primarily in Cell Culture/Upstream manufacturing
CIP/SIP/PT operations: cleaning, assembly, sterilization, disassembly, pressure test and operation of primary process equipment
Unit operations described in standard operating procedures and batch records (50%-100% of effort)
Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency
Trains Manufacturing Technicians on theories and concepts of the bioprocess operations
Completes required processing documentation including deviation reports, change control, product changeover, etc.
Identifies, creates and revises GMP documentation as required including MBRs
Performs review of GMP documentation and participates in training and development opportunities to gain understanding of compliance requirements and departmental policies.
Participates in validation activities including IQ/OQ/PQ and process validation
Assists in compliance and technical development projects
Performs document revisions to Standard Operating Procedures
Initial training and application of GMP regulations (ICH Q7A) as it applied to job function
KNOWLEDGE, SKILLS & ABILITIES:
Knowledge in relevant math, science and engineering disciplines.
Exercise independent judgement when applying industry practices and company policies to daily operations.
Demonstrated ability to communicate, read, and write in English.
Advanced computer skills including work with Excel and Word.
Must be detail oriented, with the ability to complete written and verbally assigned tasks following specific procedures.
Working knowledge of GMP regulations (ICH Q7A) as it applies to the job function.
Working knowledge of equipment and technology as it applies to this position.
Ability to interact constructively with peers and support groups.
Technical writing skills.
BS in Chemistry, Biology or other relevant discipline or equivalent combination of education and work experience
1-4 years relevant experience, including experience in aseptic processing.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE