Senior Engineer, MS&T

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

Benefits offered by this job

Annual bonus

Medical coverage

Dental coverage

Vision coverage

PTO and holidays

401K matching

Job summary

KBI Biopharma in Boulder, CO, seeks a Senior MS&T Engineer to lead downstream tech transfer and provide manufacturing support to ensure client program success. You will own process transfer decisions, act as SME for chromatography, TFF, filtration, and review critical documents while collaborating across Facilities, Process Development, QA and Supply Chain.

Requires 11+ years in bioprocess development/manufacturing, a Bachelor's in chemical or biochemical engineering, and strong knowledge of

Qualifications

• 11+ years of experience in bioprocess development or manufacturing within biotech/biopharma.
• Strong leadership in cross-functional teams and project management.
• Expertise in biologics, cell therapy, gene therapy, and drug substance production processes.

Responsibilities

• Owns process transfer and implementation decisions for a product.
• Subject Matter Expert for downstream drug substance operations (chromatography, TFF, clarification, filtration).
• Reviews and approves significant technical documents (process descriptions, qualification protocols, CPV reports).
• Generates technical solutions to difficult problems solo or with external experts.
• Delegates and manages work, with knowledge of process validation and regulatory expectations.
• On-call or on-floor support for 24/7 plant operations on a rotating basis.
• Leads and plans engineering studies toward long-range goals; conducts complex analyses.
• Leads organization within functional boundaries and may supervise resources.
• Represents KBI as primary technical contact with clients.

Skills

Bioprocess development

Project management

Cross-functional collaboration

Communication

Analytical skills

Problem-solving

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. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, PTO and holidays, 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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.