Senior Engineer, MS&T

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

Benefits offered by this job

annual bonus structure

medical, dental, and vision coverage

paid PTO and holidays

Sabbatical program

401K matching with 100% vesting in 60 

employee recognition programs

Job summary

KBI Biopharma, Inc. in Boulder, CO is seeking a Manufacturing Science & Technology Senior Engineer focused on downstream processes to drive technology transfer and support 24/7 manufacturing operations.

You will author and review critical documents and collaborate across Facilities, Process Development, Supply Chain, Quality, and Manufacturing teams. The role requires deep biosubstance experience, leadership in cross-functional teams, and strong regulatory knowledge.

Qualifications

• 11+ years of experience in bioprocess development or manufacturing within the biotech or biopharma industry.
• Expertise in biologics, cell therapy, gene therapy, drug substance production processes.
• Strong understanding of cGMP regulations, FDA/EMA guidelines, and validation principles.
• Demonstrated leadership in cross-functional teams and project management.
• Excellent communication, analytical, and problem-solving skills.
• Experience with regulatory submissions (IND, BLA, MAA) is a plus.

Responsibilities

• Provides process engineering ownership for a product, including all process transfer and implementation decisions.
• Subject Matter Expert of all downstream drug substance operations (chromatography, tangential flow filtration, clarification, normal filtration, etc.).
• Reviews and approves significant technical documents including process descriptions, process qualification protocols and reports, and CPV reports.
• Ability to generate technical solutions to a wide range of difficult problems through individual effort and leveraging external expertise.
• Ability to delegate and manage the work product of others.
• In-depth knowledge of process validation practices and associated regulatory expectations.
• Requirement for on call or on the manufacturing floor activities to support 24/7 plant operations on a rotating basis.
• Works with minimal direction toward predetermined long-range goals and objectives.
• Conceives plans and conducts engineering studies in areas of considerable scope and complexity.
• Leads efforts of organization within functional boundaries and influences efforts of adjacent organizations.
• May be expected to directly supervise project resources.
• Represents KBI as one of the primary technical contacts with clients on projects.

Skills

Leadership in cross-functional teams

Project management

Excellent communication

Analytical problem-solving

Regulatory submissions knowledge

Education

Bachelor’s in chemical engineering, biochemical engineering, or related field

Job description

The Manufacturing Science and Technology (MS&T) Senior Engineer is responsible for technology transfer activities (mainly downstream focused), document authoring/review, and manufacturing facility support to ensure client program success. The role requires significant collaboration with all departments Facilities and Engineering, Process Development, Supply Chain, Quality, and Manufacturing teams to ensure projects are executed efficiently. The Senior Engineer should demonstrate proven technical expertise in downstream microbial biologics and have strong knowledge of industry best practices.

Key Responsibilities

• Provides process engineering ownership for a product, including all process transfer and implementation decisions.
• Subject Matter Expert of all downstream drug substance operations (chromatography, tangential flow filtration, clarification, normal filtration, etc.).
• Reviews and approves significant technical documents including process descriptions, process qualification protocols and reports, and CPV reports.
• Ability to generate technical solutions to a wide range of difficult problems through individual effort and leveraging external expertise.
• Ability to delegate and manage the work product of others.
• In-depth knowledge of process validation practices and associated regulatory expectations.
• Requirement for on call or on the manufacturing floor activities to support 24/7 plant operations on a rotating basis.
• Works with minimal direction toward predetermined long-range goals and objectives.
• Conceives plans and conducts engineering studies in areas of considerable scope and complexity.
• Leads efforts of organization within functional boundaries and influences efforts of adjacent organizations.
• May be expected to directly supervise project resources.
• Represents KBI as one of the primary technical contacts with clients on projects.

Qualifications

• Bachelor’s in chemical engineering, Biochemical Engineering, or related field
• 11+ years of experience in bioprocess development or manufacturing within the biotech or biopharma industry
• Expertise in biologics, cell therapy, gene therapy, drug substance production processes
• Strong understanding of cGMP regulations, FDA/EMA guidelines, and validation principles
• Demonstrated leadership in cross-functional teams and project management
• Excellent communication, analytical, and problem-solving skills
• Experience with regulatory submissions (IND, BLA, MAA) is a plus

Salary Range: $118,000.00 - 178,000.00 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range.

Benefits

• annual bonus structure for all employees
• medical, dental, and vision coverage
• paid PTO and holidays
• Sabbatical program
• 401K matching with 100% vesting in 60 days
• employee recognition programs

Equal Opportunity Employment

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them. We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills. At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.