Senior Engineer, MS&T

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 -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:

• Bachelors 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: $118000.00 - 178000.00

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidates 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.

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.