Bioconjugation Process Development & Manufacturing Lead

Telix Pharmaceuticals (AMER)•Angleton, TX

2d•Hybrid

About The Position

The Bioconjugation Process Development and Manufacturing Lead will provide technical leadership and hands-on execution for purification process development, technology transfer, process optimization, scale-up, and manufacturing support of bioconjugate programs. This role is responsible for developing and transferring purification and conjugation processes for proteins from development laboratories to GMP manufacturing environments. The successful candidate will be an experienced process development and manufacturing scientist with expertise in chromatography-based purification platforms, process scale-up, and GMP manufacturing operations. The individual will independently design and execute laboratory studies, author development and technology transfer documentation, establish scalable manufacturing processes, and support manufacturing campaigns at internal facilities. This position requires significant hands-on experience operating, troubleshooting, and commissioning chromatography systems similar to ÄKTA Avant, ÄKTA Pure, and ÄKTA Pilot systems in both non-GMP and GMP environments.

Requirements

Science or engineering degree with minimum relevant experience as applicable: BS with 5 years of experience, MS with 3 years of experience, PhD with 2 years of experience.
Minimum 2 years of hands-on experience in purification process development, purification process scale-up, or biologics manufacturing.
Demonstrated hands-on experience developing, optimizing, and scaling chromatography-based purification processes for recombinant proteins, monoclonal antibodies, antibody fragments, fusion proteins, and/or bioconjugates.
Demonstrated experience transferring manufacturing processes from development laboratories into GMP manufacturing facilities.
Hands-on experience working in both non-GMP and GMP environments.
Experience supporting clinical and/or commercial biologics manufacturing campaigns.
Ability to work in radiation areas after appropriate training.
Extensive hands-on experience operating and configuring ÄKTA chromatography systems.
Strong understanding of purification process scale-up principles, control strategies, and manufacturing readiness.
Experience authoring development reports, technology transfer packages, protocols, manufacturing instructions.

Nice To Haves

Experience managing complex projects is a plus
Knowledge of GMP requirements, quality systems, deviation management, change control, CAPA, and tech transfer best practices.
Hands-on experience in bioconjugation process development, conjugation scale-up, conjugate purification, and manufacturing support.

Responsibilities

Design, execute, analyze, and document downstream process development studies, including chromatography, ultrafiltration/diafiltration, buffer exchange, impurity clearance purification activities.
Lead technology transfer, optimization, scale-up of purification processes for pre-conjugated and post-conjugated proteins from development laboratories to GMP manufacturing facilities.
Develop scalable purification processes from early-stage development through commercial manufacturing, leveraging Quality by Design (QbD) principles and process characterization approaches.
Provide hands-on operation, setup, troubleshooting, and execution of purification runs using ÄKTA Avant, ÄKTA Pure, and ÄKTA Pilot systems in both development and GMP manufacturing environments.
Support GMP manufacturing operations by performing or overseeing purification activities, troubleshooting process performance, investigating deviations, and implementing corrective actions.
Manage GMP bioconjugation activities while working with associated manufacturing and quality control teams.
Provide technical leadership for process scale-up activities including equipment fit assessments, process performance evaluation, facility readiness reviews, and manufacturing campaign support.