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

Medical, dental, and vision coverage

PTO and holidays

401K with vesting

Job summary

KBI Biopharma, Inc. in Boulder, Colorado, seeks a Senior Engineer for Manufacturing Science and Technology to lead downstream technology transfer, document authoring, and plant support for client programs.

This role requires collaboration across Facilities, Process Development, Supply Chain, Quality, and Manufacturing to ensure efficient project execution. You will serve as downstream SME for chromatography, filtration, and related operations, review critical documents, manage cross-functional

Qualifications

• Bachelor’s degree in chemical engineering, biochemical engineering, or related field.
• 11+ years of experience in bioprocess development or manufacturing in biotech/biopharma.
• Expertise in biologics, cell therapy, gene therapy, and drug substance production.
• Strong understanding of cGMP, 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

• Provide process engineering ownership for product transfer and implementation decisions.
• Subject Matter Expert for downstream drug substance operations (chromatography, TFF, clarification, filtration).
• Review and approve technical documents including process descriptions and validation reports.
• Generate technical solutions and leverage external expertise.
• Possibly supervise project resources and delegate work.
• Support 24/7 plant operations on a rotating basis.

Skills

Bioprocess development

Biopharma industry

Biologics

cGMP compliance

Regulatory submissions

Project management

Cross-functional leadership

Communication skills

Analytical skills

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

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

• 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.

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.

If you do not see a position that matches your background, we invite you to return to our site often as positions are updated frequently.

Please Note: To 3rd Party Search Firms/Employment Agencies: All inquiries must be directed to [e-mail]. Please do not call or email any KBI Biopharma employee about current or future job openings. All resumes submitted by search firms or employment agencies to any employee at KBI Biopharma via-email, telephone, social media or other means will be deemed to be the sole property of KBI Biopharma, unless the firm submitting the resume has previously entered into a written agreement with KBI Biopharma regarding recruitment services and has been approved by Human Resources to work on an open position. KBI Biopharma will not pay any fee or remuneration with respect to candidates without complying with this requirement.