Scientist IV, BioConjugation (ADC) Process Development, Biologics CMC

SUMMARY / JOB PURPOSE :

The Scientist IV, 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.

ESSENTIAL DUTIES AND 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.

SUPERVISORY RESPONSIBILITIES :

None. Directing work only (no direct reports, but directing work to a CMO, Consultant or 3rd party.)

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education :

Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 5 years of relevant industry experience; or,

Master’s degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 3 years of relevant industry experience; or,

Equivalent combination of education and experience.

Experience / The Ideal for Successful Entry into Job :

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.).

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.

Knowledge / 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 details.

A demonstrated ability to work both independently and as a member of local and global Teams.

WORKING CONDITIONS :

Environment : primarily working in laboratories or in office

Exposures encountered, such as hazardous materials, and extreme cold.

Limited travel requirement

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Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets.

The base pay range for this position is $100,000 - $141,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location.

The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, 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.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.