Downstream Process Development - Principal Scientist

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:

This is a Principal Development Scientist position in the Downstream Process Development group.  Primary responsibilities include development of processes and characterization for GMP manufacturing, client management, and technology development. In addition, management and scientific mentoring of junior personnel, and helping to support and manage laboratory and equipment operations.

 

PRINCIPAL RESPONSIBILITIES:

• Coordinate downstream development activities leading to clinical and commercial manufacturing for multiple client projects
• Work with clients and internal project teams in the successful completion of contract manufacturing projects
• Present data at client project teams and written reports
• Take a leadership role within the department for developing downstream processes:
• Design downstream processes capable of scaling to GMP production in the AGC manufacturing environment
• Develop, coordinate, and communicate experimental plans within the department
• Execute and manage DoE modeling of critical protein purification processing, and bench scale experiments
• Manage large data sets and provide technical guidance to others in the analysis and interpretation of data
• Assesses data integrity to provide expert interpretations and recommendations to project teams
• Write contract manufacturing development reports, characterization development protocols and characterization reports
• Coordinate activities and experiments with project management, manufacturing, upstream development, and analytical development
• Provide technical support to manufacturing during large scale manufacturing campaigns
• Leads peers, scientifically, with experimental design and innovation, successful initiatives and a superior understanding of scientific disciplines
• Contribute to the overall operation of the lab and infrastructure improvements
• Provide technical support in the laboratory as necessary
• Implementation of new equipment and technology
• Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives

 

KNOWLEDGE, SKILLS & ABILITIES:

• Background in downstream purification development and process characterization
• Management experience of a scientific staff
• Excellent technical writing and presentation skills
• Establishes new scientific and technical directions.
• Taking a strategic view, contributes with organization-wide impact.

 

EDUCATION/EXPERIENCE:

• BS/BA and 22+ years of experience, MS/MA and 15+ years of experience, or PhD or equivalent and 12+ years of experience. Equivalent education and experience may substitute for stated requirements. 
• Demonstrated experience in a protein purification and characterization of processes
• Evidence of supervisory, technical guidance and leadership experience
• Experience with process validation activities and knowledge of large scale manufacturing activities in a GMP environment
• Experience with JMP or other statistical analysis tools would be beneficial

 

COMPENSATION RANGE:

$164,400 - $226,050

 

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 A