Senior Engineer

Manufacturing Science and Technology Senior EngineerThe 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 ResponsibilitiesProvides 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 field11+ years of experience in bioprocess development or manufacturing within the biotech or biopharma industryExpertise in biologics, cell therapy, gene therapy, drug substance production processesStrong understanding of cGMP regulations, FDA/EMA guidelines, and validation principlesDemonstrated leadership in cross-functional teams and project managementExcellent communication, analytical, and problem-solving skillsExperience with regulatory submissions (IND, BLA, MAA) is a plusSalary Range: $118,000.00 - 178,000.00Salary 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 programsKBI 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.