TFF Process Engineer - GMP Scale-Up Expert

MEDVACON LIFE SCIENCES, LLC; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

MEDVACON Life Sciences, LLC in New Jersey seeks an experienced Tangential Flow Filtration (TFF) Subject Matter Expert to provide technical leadership in process development and manufacturing for regulated pharmaceutical programs.

The successful candidate will lead TFF strategy, scale-up, validation, and troubleshooting, collaborating with QA, Regulatory, Engineering, and Manufacturing to ensure compliant, robust processes.

Qualifications

• Significant pharma experience in Tangential Flow Filtration.
• Proven ability to scale and troubleshoot TFF processes.
• Knowledge of membrane selection and operating parameters.
• Experience with GMP manufacturing and process validation.
• Support regulatory interactions and vendor evaluations.

Responsibilities

• Serve as SME for TFF process development, scale-up, validation.
• Develop and evaluate TFF processing strategies.
• Assess parameters, membranes, flux, pressure and diafiltration.
• Support GMP manufacturing scale-up and implementation.
• Develop process characterization and validation strategies.
• Provide input to protocols, risk assessments, control strategies.
• Support regulatory interactions related to processes.
• Troubleshoot performance, fouling, yield and scale-up challenges.
• Collaborate with vendors and cross-functional teams.

Skills

TFF SME

Process development

GMP manufacturing

Process validation

Regulatory support

Vendor collaboration

Job description

MEDVACON Life Sciences, LLC in New Jersey seeks an experienced Tangential Flow Filtration (TFF) Subject Matter Expert to provide technical leadership in process development and manufacturing for regulated pharmaceutical programs.

The successful candidate will lead TFF strategy, scale-up, validation, and troubleshooting, collaborating with QA, Regulatory, Engineering, and Manufacturing to ensure compliant, robust processes.