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 and cell and gene therapies. 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.

JOB SUMMARY

Responsible for bioprocess operations in Manufacturing and compliance with established processes and standards. 

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Responsible for bioprocess operations (bioreactor inoculation, filtration, purification, cell culture/separation, chromatography, or recovery) as well as CIP/SIP operations (cleaning, assembly, sterilization, disassembly, and operation)
• Complete processing documentation (including deviation reports, change control, product changeover, etc.)
• Create, review, and revise GMP documentation (SOPs)
• Recommend and execute projects and bioprocess operation improvements to reduce risk and increase efficiency
• Train others in bioprocess operations and documentation practices

• Participate in compliance and technical development projects
• Supports or may lead multiple more complex projects/initiatives/work items under broad supervision
• Analyzes issues and makes decisions based on standardized processes and procedures under close supervision
• Communicates moderately complex concepts and interacts with others to inform and direct action
• Acts as a resource for less experienced team members and colleagues

LEADERSHIP SKILLS

• Analyzes multiple sources of information and evaluates several alternative solutions before confirming correct path
• Explains complicated information and effectively lays out variations of alternatives to consider
• Works across teams effectively

• Applies understanding of how the team relates to other closely related areas to improve efficiency of own team

QUALIFICATIONS 

Required:

• BS/BA degree and 5 years of relevant experience. 8 years of GMP relevant experience may substitute for stated requirements

Compensation Band:

$ 37.54 - $45.05

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.