Manufacturing Specialist I/II

About AGC Biologics  
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.   

 

SUMMARY: 

The Manufacturing Specialist I/II will be responsible for identifying and executing projects that relate to manufacturing readiness, right first-time execution, CAPA implementation and broad process improvements on the manufacturing floor and facility. This role works in close collaboration with site cross functional groups including, but not limited to QA, MSAT, Validation, and Facilities/Engineering.

PRINCIPAL RESPONSIBILITIES

• Support the implementation of corrective actions, change controls, and general process improvements in close collaboration with Process Transfer/Process Development, Engineering, QA, and Validation teams.
• Provide support and training to manufacturing staff for new equipment and processes.  
• Ensure process optimization and continuous improvement.
• Identify modern technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.
• Collaborate with engineering and validation teams to implement and qualify new equipment and controls.
• Author updates, review and approve quality documents, such as Standard Operating Procedures (SOPs) and other technical procedures.
• Follow-up on production campaigns including review and approval of executed batch records, troubleshooting, handling of Change Records and CAPAs.
• Represent the interests of the Manufacturing team, serve in multidisciplinary project teams, collaborating closely with other team members in a cooperative fashion to ensure project progression.
• Work closely with Manufacturing operations and QA team to drive CAPAs to timely closure.
• Serve as liaison between multiple groups including Manufacturing, Quality, and Process Development

KNOWLEDGE, SKILLS AND ABILITIES 

• Ability to interact constructively and influence peers and support groups.
• Prior experience technical writing and in a manufacturing environment preferred.
• Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time delivery. Must work well on a team and be able to troubleshoot and problem solve in a cross functional team setting.  Must be initiative-taking, action oriented, and have the ability to adapt to change.  Must be able to identify and flag risks in a timely manner to keep deliverables on track.
• Strong written and verbal communication skills are required. Ability to read and comprehend complex subjects. Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.
• Ability to understand and apply GMP regulations as they relate to manufacturing.

 EDUCATION/EXPERIENCE

• BA/BS degree in a science related discipline preferred or combination of education and work experience.
• Minimum 2+ years’ experience in bioprocessing manufacturing, preferably in large-scale operations
• Expertise in GMP and bioprocessing knowledge

 COMPENSATION RANGE:

 

$66,960 - $103,070

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Membe