Bioconjugation Process Development & Manufacturing Lead

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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.

Key Accountabilities

• 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.

Education and Experience:

• 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.
• Experience managing complex projects is a plus
• Ability to work in radiation areas after appropriate safety training.

Technical Requirements

• 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.
• Preferred: Knowledge of GMP requirements, quality systems, deviation management, change control, CAPA, and tech transfer best practices.
• Preferred: Hands-on experience in bioconjugation process development, conjugation scale-up, conjugate purification, and manufacturing support.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges