Senior Engineer, MS&T

KBI Biopharma•Boulder, CO

2d•$118,000 - $178,000•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Experience with regulatory submissions (IND, BLA, MAA) is a plus

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.