Senior MS&T Engineer: Tech Transfer & Process Innovation

Elektrofi; Boston (MA); On-site; USD 116,000 - 162,750; Full time

Benefits offered by this job

Employee Stock Purchase Program

401(k) matching

Tuition reimbursement

Job summary

Halozyme Hypercon is seeking a Senior Engineer II, Manufacturing Science and Technology to execute technology transfer and continuous process improvements for our Hypercon formulation process. You will support CDMOs and partner sites, interfacing with PM, Analytical & Process Development, Quality, Supply Chain, Engineering and Manufacturing.

Global travel up to 25% during start-up is possible. Lean Six Sigma will be used to measure KPIs and drive performance improvements in a fast-paced

Qualifications

• Eight years in a cGMP/cGCP environment is required, preferably in biologics or cell & gene therapy.
• Minimum of 5 years supporting process technology transfers and new site start-ups.
• Experience with aseptic bulk formulation and filling for mABs, ADCs, AOCs, vaccines, or cell & gene therapies.

Responsibilities

• Technology transfer execution and routine manufacturing support for bulk aseptic formulation and filling.
• Create technology transfer plans, campaign reports, change controls, and CMC documentation.
• Lead process and manufacturing risk assessments with mitigation plans.
• Review engineering drawings, P&ID, automation modules, batch records, and validation strategies.
• Coordinate with internal and external stakeholders for production plans and capacity.

Skills

Technology transfer

cGMP experience

Biologics engineering

Process development

Cross-functional

Education

Bachelor's degree in Engineering

MS/PhD in Engineering (plus)

Job description

Halozyme Hypercon is seeking a Senior Engineer II, Manufacturing Science and Technology to execute technology transfer and continuous process improvements for our Hypercon formulation process. You will support CDMOs and partner sites, interfacing with PM, Analytical & Process Development, Quality, Supply Chain, Engineering and Manufacturing.

Global travel up to 25% during start-up is possible. Lean Six Sigma will be used to measure KPIs and drive performance improvements in a fast-paced