Scientist III - Bioconjugation (ADC) Process Development

Exelixis • Alameda, CA

3d

About The Position

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.

Requirements

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 3 years of relevant industry experience; or,
• Master’s 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.
• Direct experience designing and implementing experiments to evaluate bioconjugation processes, including ADCs, is preferred.
• Hands-on experience with ADC chemistry, reaction processes and purification methods (i.e. Tangential flow filtration, chromatography, etc.).
• 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 details.
• A demonstrated ability to work both independently and as a member of local and global teams.

Nice To Haves

• Demonstrated experience and working knowledge of technical transfer for Biologics manufacturing (bioconjugations), is a plus.
• Additional experience with the development and manufacturing of mAbs, bispecifics and/or linker-toxins used in ADC production, and familiarity with analytical methods, is a plus.

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.

Benefits

• Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
• Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees