JOB SUMMARY:

The Upstream MS&T Senior Engineer will apply sound scientific and engineering principles to successfully transfer, enroll, and manage new biopharmaceutical processes in the cGMP manufacturing facility. The scope of this role includes:

• Leading and providing guidance on multiple technical transfer projects for challenging clinical and commercial manufacturing programs

• Leading commercial project/product as process steward, and leading supporting activities for process validation

• Driving business decisions and operations related to facility fit, time in plant and new technologies or equipment and communicating recommendations to the client

• Performing facility fit activities including process flow diagram generation, scaleup calculations, defining equipment and solution requirements, and generation of bill of materials (BOM) and new item specifications

• Providing supervisory and technical support for cGMP production runs, CAPAs, process and product impact assessments for deviations and change controls Providing supervisory and technical support during technical document execution, new equipment testing, water runs in manufacturing.

• Collecting and analyzing process data, experimental study data (i.e. multivariate analysis), and communicating out to the client and upper management via production updates and campaign summary reports

• Leading complex investigational and troubleshooting efforts and providing recommendations to manufacturing and PD for implementation

• Leading collaboration on strategic and complex projects or studies with external partners (i.e. process development, vendors), providing mentorship to other engineers, and presenting results in technical reports and internal and external (industry technical conference) presentations

• Supporting IND and BLA filing, and providing guidance with US, EU, and ICH regulations and guidelines

• Serving as a technical SME during regulatory and approval inspections, authoring storyboards and presenting to regulatory agencies

JOB RESPONSIBILITIES:

The candidate should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines. The ability to manage multiple projects and resources is required. The candidate should have the ability to work independently and with teams (in a supervisory role). The candidate should also possess excellent communication skills.

• Lead technical transfer of new processes into manufacturing and conduct facility fit, author PFDs, develop time in plant estimates and define equipment selection.

• Author / Review technical documents including supporting batch records, solution/media records, project reports, manufacturing process calculations templates, user requirements specifications, etc.

• Lead technical deviation investigations and collaborate with Manufacturing, Investigators and QA to determine event impact, perform root-cause analysis and corrective action identification and implementation.

• Bill of Material (BOM) generation for new process introductions as well as updating BOMs for process modifications.

• Determine equipment sizing, media and solution preparation methods and volumes, and assist in coordinating with vendor.

• Collect, organize, and analyze process data from engineering and manufacturing runs for presentation at project meetings.

• Escort client into manufacturing suites for Person in Plant activities

MINIMUM REQUIREMENTS:

• BS in Science or Engineering with minimum of 9 years industry experience, Master’s with 7 years industry experience, or PhD with 6 years industry experience.

• Extensive expertise in upstream and/or downstream processing techniques and equipment in biologics

• Expertise in technical transfer and scale up is required

• Knowledge of industry best practices is preferred including equipment design, process technologies, process validation and requirements of regulatory agencies (health authorities) is required.

• Experience with GMP compliance requirements

• Working knowledge of Process Development and technical knowledge supporting IND development and GMP production

• Experience working in a cGMP manufacturing environment in a technical or engineering role is preferred

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, 401K matching, and employee recognition programs.

About KBI:

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

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.