Senior Engineer, Downstream Biologics & Process Transfer

KBI Biopharma; Boulder (CO); On-site; USD 118,000 - 178,000; Full time

Benefits offered by this job

Annual bonus

401K matching

PTO & holidays

Sabbatical program

Medical, dental & vision coverage

Job summary

KBI Biopharma is seeking a Manufacturing Science and Technology Senior Engineer to lead downstream process transfers, author and review critical documents, and support 24/7 manufacturing operations. The role requires deep bioprocess expertise and strong collaboration across Facilities, Process Development, QA, and Manufacturing.

Ideal candidates will have 11+ years in bioprocess development or manufacturing, with leadership experience and familiarity with cGMP, FDA/EMA guidelines, and regulatory

Qualifications

• 11+ years of bioprocess development or manufacturing experience
• Expertise in biologics, cell therapy, gene therapy, and drug substance production
• Strong knowledge of cGMP regulations, FDA/EMA guidelines, and validation principles
• Demonstrated leadership in cross-functional teams and project management

Responsibilities

• Own process transfer and implementation decisions for a product
• Subject Matter Expert for downstream drug substance operations (chromatography, tangential flow filtration, etc.)
• Review and approve significant technical documents including process descriptions and CPV reports
• Generate technical solutions to a wide range of difficult problems with individual effort and external expertise
• Delegate and manage the work product of others and supervise project resources
• Provide on-call or floor support to enable 24/7 plant operations on a rotating basis
• Lead cross-functional efforts and influence adjacent organizations; may supervise resources
• Represent KBI as a primary technical contact with clients on projects

Skills

Leadership

Communication

Problem solving

Education

Bachelor's in chemical engineering

Biochemical Engineering

Job description

KBI Biopharma is seeking a Manufacturing Science and Technology Senior Engineer to lead downstream process transfers, author and review critical documents, and support 24/7 manufacturing operations. The role requires deep bioprocess expertise and strong collaboration across Facilities, Process Development, QA, and Manufacturing.

Ideal candidates will have 11+ years in bioprocess development or manufacturing, with leadership experience and familiarity with cGMP, FDA/EMA guidelines, and regulatory