Senior Biopharma Process Engineer - Tech Transfer & Readiness

Lotte Biologics; City of Syracuse (NY); On-site; USD 110,000 - 154,000; Full time

Job summary

LOTTE BIOLOGICS in East Syracuse, NY seeks a Senior Process Engineer to lead biotech manufacturing readiness, tech transfer, and lifecycle optimization for monoclonal antibody (mAb) and antibody-drug conjugate (ADC) processes within a CDMO environment.

You will collaborate with MS&T, Facilities, and Capital Projects to ensure manufacturing readiness, facility-fit, and robust process performance, owning technical decisions from proposal through commercial manufacturing and lifecycle improvements.

Qualifications

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field is required; advanced degree preferred.
• 8+ years in biopharmaceutical process engineering with CDMO or multi-client experience strongly preferred.
• Experience with mAb manufacturing; ADC manufacturing experience and containment systems preferred.
• Proven leadership in cross-functional technical initiatives with impact on quality, safety, cost, or schedule.
• Professional Engineer licensure or relevant pharmaceutical engineering/training is beneficial but not required.

Responsibilities

• Serve as the senior process engineering owner for client programs and manufacturing platforms across technology transfer and lifecycle improvement.
• Lead risk-based, independent engineering decisions involving process design, scale-up, and GMP compliance; document rationale and risks.
• Coordinate cross-functional problem solving across MS&T, Manufacturing, Quality, Facilities, and other teams; drive durable solutions.
• Lead facility-fit and manufacturing-readiness assessments for mAb and ADC processes, evaluating equipment, automation, utilities, and containment.
• Translate client process knowledge into robust engineering deliverables, including URS, flow diagrams, mass/energy balances, and acceptance criteria.
• Own technical gap assessments and recommend equipment modifications or capital investments; emphasize safety, quality, and cost.
• Interface with clients and governance teams; present positions, resolve conflicts, and communicate residual risks.
• Provide leadership for technology transfer, scale-up, validation, and routine operations, ensuring readiness and transfer of knowledge.
• Lead structured risk assessments for process/equipment interfaces; ensure closure and ownership.
• Direct resolution of deviations and bottlenecks using first-principles engineering and data analysis; drive CAPAs.
• Oversee design reviews, FAT/SAT, commissioning, qualification, startup, and handover for new installations and expansions.
• Define engineering acceptance criteria for upstream, downstream, single-use, and high-potency systems as applicable.
• Prepare and review high-quality technical deliverables and CGMP-compliant documentation.

Skills

Biopharmaceutical process engineering

MAb & ADC processing

Cross-functional leadership

Technical decision making

Client-facing

Education

Bachelor’s degree in Chemical Engineering or related

Professional Engineer licensure or equivalent (beneficial)

Job description

LOTTE BIOLOGICS in East Syracuse, NY seeks a Senior Process Engineer to lead biotech manufacturing readiness, tech transfer, and lifecycle optimization for monoclonal antibody (mAb) and antibody-drug conjugate (ADC) processes within a CDMO environment.

You will collaborate with MS&T, Facilities, and Capital Projects to ensure manufacturing readiness, facility-fit, and robust process performance, owning technical decisions from proposal through commercial manufacturing and lifecycle improvements.