Downstream MS&T Engineer II/III

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 with minimal direction and have excellent communication skills.

The scope of this role includes:

• Lead technical transfer projects for new molecules as well as platform and/or repeat early-mid stage clinical manufacturing programs
• Support and/or drive 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 (PFD) generation, scale­ up calculations, defining equipment and solution requirements, and generation bill of materials (BOM) and new specifications
• Providing technical support for cGMP production runs, deviations, change controls, and CAPAs
• Compiling process data and communicating out to the client and upper management via production updates and campaign summary reports.
• Supporting/leading complex investigational and troubleshooting efforts and providing recommendations to manufacturing for implementation
• Supporting/leading collaboration on strategic projects or studies with external partners (i.e. process development, vendors) and presents results in technical reports
• Author/Review Material Specifications in accordance with compendia requirements and meeting grade requirements for introduced process.

Minimum Requirements:

• Level II: BS in Science or Engineering with minimum of 4 years industry experience, Masters with 2 years industry experience or PhD with no years industry experience.
• Level III: BS in Science or Engineering with minimum of 7 years industry experience or Masters with 5 years industry experience or PhD with 3 years industry experience
• Expertise in upstream and/or downstream processing techniques and equipment in biologics
• Experience with technical transfer and scale up is required
• Experience with GMP compliance requirements
• Working knowledge of Process Development and technical knowledge supporting IND development and early phase cGMP production
• Working knowledge of late stage and commercial programs is an added bonus
• Experience working in a cGMP manufacturing environment is preferred

Salary ranges:

MS&T Engineer II - $73,265.00 / yr - $100,739.00 / yr

MS&T Engineer III - $92,933.00 / yr - $127,783.00 / yr

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. 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 is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

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.