Senior MS&T Engineer — Downstream Biologics & Transfer

KBI Biopharma

Boulder (CO)

On-site

USD 118,000 - 178,000

Full time

4 days ago

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Benefits offered by this job

Annual bonus

Medical coverage

Dental coverage

Vision coverage

PTO and holidays

401K matching

Job summary

KBI Biopharma in Boulder, CO, seeks a Senior MS&T Engineer to lead downstream tech transfer and provide manufacturing support to ensure client program success. You will own process transfer decisions, act as SME for chromatography, TFF, filtration, and review critical documents while collaborating across Facilities, Process Development, QA and Supply Chain.

Requires 11+ years in bioprocess development/manufacturing, a Bachelor's in chemical or biochemical engineering, and strong knowledge of

Qualifications

11+ years of experience in bioprocess development or manufacturing within biotech/biopharma.
Strong leadership in cross-functional teams and project management.
Expertise in biologics, cell therapy, gene therapy, and drug substance production processes.

Responsibilities

Owns process transfer and implementation decisions for a product.
Subject Matter Expert for downstream drug substance operations (chromatography, TFF, clarification, filtration).
Reviews and approves significant technical documents (process descriptions, qualification protocols, CPV reports).
Generates technical solutions to difficult problems solo or with external experts.
Delegates and manages work, with knowledge of process validation and regulatory expectations.
On-call or on-floor support for 24/7 plant operations on a rotating basis.
Leads and plans engineering studies toward long-range goals; conducts complex analyses.
Leads organization within functional boundaries and may supervise resources.
Represents KBI as primary technical contact with clients.