SUMMARY/JOB PURPOSE:

The incumbent will be responsible for the day-to-day execution activities directed to support development and manufacturing of biological (antibody drug conjgates, mAbs, bispecifics) drug products (DP). The activities include formulation development, DP manufacturing process development, DP process technical transfer, activities to support preparation and administration of DP and selection and development of primary container closure.  The work would include but not limited to outlining,  designing, executing and managing various activities in house or at CMO/CRO including maintaining up to date documentation and records. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

Design and execute studies in house. Manage similar activities at CRO/CMO. 

Perform biophysical characterization and analytical assays for biologics development: e.g., DLS, SEC, CE, cIEF, ELISA, LC-MS, Peptide Mapping. Design and execute stability, administration, container closure selection and other DP development and manufacturing related studies. 

Perform hands-on documentation and data review. Present data to functional memebrs and leaders 

Work closely with functional and cross functional CMC and non CMC colleagues as well as with contract labs.

Collaborate effectively within CMC (analytical, drug substance), QA and RA etc. and outside contract laboratories with excellent communication to maintain strong relationships.

Stay current with journal articles and changing regulatory requirements regarding analytical testing.

Help to identify and draft work instructions/SOP for relevant analytical methods

SUPERVISORY RESPONSIBILITIES:

This is an independent role

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: 

Education/Experience:

BS/BA in Pharmacy, Chemical Engineering, Biochemstry, Physical Chemistry, or related discipline and a minimum of three years of related experience; or, 

MS/MA in Pharmacy, Chemical Engineering, Biochemstry, Physical Chemistry, or related discipline and a minimum of one years of related experience; or,

Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Experience in formulation development and biophysical characterization of biologics (mAbs, ADC etc.) and novel biological modalities such as gene and cell therapies in industry or in academia is preferred. Experience with lyophilization development is preferred and would be a plus.

Experience with sterile DP manufacturing including technical transfer is preferred.

Experience in Analytical Development in the pharmaceutical industry and/or academia is preferred. Experience developing analytical methods, specifically HPLC methods, for testing biological drug substances and drug products is preferred.

Experience conducting stability studies is preferred.

Experience working with contract laboratories is desirable.

Hands on experience with analytical instrumentation is preferred.

Experience in biologics drug product development is preferred

Experience in formulation development, DP process development, container closures and devices, preparation and administration of biological and/or novel biological modalities is preferred

Experience planning, generating, analyzing, and linking experimental capabilities and results to critical CMC objectives is preferred

Knowledge/Skills:

Drug product development and/or manufacturing

Knowledge of CMC biologics processes 

Ability to collaborate and work effectively cross-functionally and in a team setting, both internally and with external CDMOs and partners 

Ability to multi-task in a fast-paced dynamic environment while delivering high quality work 

Excellent interpersonal, presentation, and written communication skills 

Creative thinker and complex problem solver

JOB COMPLEXITY:

WORKING CONDITIONS:

Environment: primarily working in laboratories or in office

Exposures encountered, such as hazardous materials, extreme cold.

Travel required ~10% of time

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

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 $89,500 - $127,500 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.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.