Senior Engineer, MS&T

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

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. KBI has a robust total rewards strategy which includes an 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 and employee recognition programs

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.