Scientist III - Bioconjugation (ADC) Process Development

Role Summary

The Scientist III, Bioconjugation (ADC) Process Development, will have an opportunity to contribute to Exelixis’ Antibody Drug Conjugates (ADCs) technology platforms. The successful candidate will be responsible for the development of scale-able and robust downstream ADC processes and support technology transfer efforts, leading to clinical GMP manufacturing of ADCs.

Responsibilities

• Technical knowledge at design, execution and data interpretation of experiments related to development, optimization, and scale-up of biologics with a focus on ADC Bioconjugation and Purification processes.
• Develop Subject Matter Expertise in bioconjugation (ADC) process development and manufacturing in support of CMC activities.
• Work closely with research function to understand relevant conjugation chemistries and transition bioconjugation process from research to CMC development.
• The ability to identify, evaluate, and implement new and existing technologies to improve process efficiency, control, and understanding.
• Experience in applying DOE and other advanced statistical techniques to design experiments (DoE) related to process development.
• Familiarity with authoring high-quality documents, including technical reports, SOPs, experimental protocols, drafting tech transfer related documents (process description, process flow diagrams, tech transfer reports, etc.) reviewing batch records, and sampling plans.
• The ability to contribute to MFG floor activities and provide scale up, technical support and troubleshooting to MFG groups at clinical and commercial manufacturing sites.
• Demonstrated ability to work effectively with CDMOs, is a plus.
• A familiarity with critically relevant areas such as analytical, formulation, and the general CMC scope for biologics is preferred.

Qualifications

• Required: Bachelor‚Äôs degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 3 years of relevant industry experience.
• Required: Master‚Äôs degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 1 year of relevant industry experience.
• Required: Equivalent combination of education and experience.
• Preferred: Direct experience designing and implementing experiments to evaluate bioconjugation processes, including ADCs.
• Preferred: Hands-on experience with ADC chemistry, reaction processes and purification methods (e.g., Tangential flow filtration, chromatography).
• Preferred: Demonstrated experience and working knowledge of technical transfer for Biologics manufacturing (bioconjugations).
• Preferred: Additional experience with the development and manufacturing of mAbs, bispecifics and/or linker-toxins used in ADC production, and familiarity with analytical methods.

Skills

• Ability to collaborate with cross-functional teams, both internally and with external CDMOs and partners.
• Ability to multi-task in a fast-paced dynamic environment while delivering high-quality work.
• Self-motivated, accountable, and inquisitive attitude with excellent interpersonal, presentation, and written communication skills.
• Creative thinker and complex problem solver with strong attention to detail.
• A demonstrated ability to work both independently and as a member of local and global teams.
• Environment: primarily working in laboratories or in office.
• Exposures encountered, such as hazardous materials, and extreme cold.

Education

• Bachelor‚Äôs degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 3 years of relevant industry experience; or
• Master‚Äôs degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 1 year of relevant industry experience; or
• Equivalent combination of education and experience.

Additional Requirements

• Limited travel required.