Sr Scientist II (Analytical Development Biologics CMC)

SUMMARY/JOB PURPOSE:

The Sr Scientist II, Analytical Development, Biologics CMC will support the CMC analytical development for multiple types of biologics including but not limited to antibody-drug conjugates (ADC), monoclonal antibodies and bispecifics. The incumbent will utilize their technical expertise in CMC analytical areas such as method development, product characterization, CQA assessment, and control strategy to advance CMC development and manufacturing for pre-IND and in-clinic biological molecules. The incumbent is expected to work in the laboratory to support method development, analytical transfer to CDMO, internal and external process development. The incumbent will also support CDMO management, such as method development, method qualification/validation, and product characterization performed at CDMO.

Strong ownership is critical to ensure the speed, cost-effectiveness, and technical quality of our CMC activities. The individual will work independently and in cross-functional teams, and work effectively with third-party CDMOs and partners.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• The incumbent is the subject matter expert (SME) for multiple analytical assays. S/He will perform method development to support the CMC development of ADC, monoclonal antibody and bispecific molecules.
• Support CDMO management to perform method development and method qualification/validation. Transfer analytical methods from early research development to CDMO to support process development. Review protocols and reports from CDMO.
• As the SME, the incumbent will review GMP release and stability testing results. Support OOS/OOT, deviation, and investigations occur at GMP sites.
• Support building in-house laboratory capability and team for method development and testing support. Bring in new analytical technologies for novel biotherapeutic proteins.
• Maintain instruments of the internal lab
• Support CQA assessment and relevant development studies (e.g., forced degradation study and chromatographic peak identification) for a comprehensive understanding of the product structure-function relationship.
• Build collaborative relationships with other stakeholders including DS and DP Manufacturing, Process Development, Project Manager, Quality Assurance, and Regulatory Affairs
• Author internal method procedures, SOP, study protocols, and reports
• Support the IND/IMPD writing, review, and regulatory responses

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 9 years of relevant industry experience; or,
• Master's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 7 years of relevant industry experience; or,
• Ph.D. in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related field and a minimum of 2 years of relevant industry experience; or,
• Equivalent combination of education and experience.

Experience:

• Demonstrated hands-on experience with a broad range of analytical assays for mAb, BsAb and ADC, such as SEC, icIEF, CE-SDS, HIC, RP-HPLC, glycan analysis, residual-free drug analysis, residual HCP, residual DNA, and endotoxin.
• Demonstrated hands-on experience in assay development, especially for SEC, icIEF, CE-SDS, HIC, and residual-free drug analysis, is desired
• Experience in 2D-LC method development is a plus
• Experience in protein structural elucidation and peak identification using high-resolution mass spectrometry is a plus
• Experience in interfacing with CDMO/CTL for clinical or commercial biological products development is a plus
• Experience in method transfer and GMP qualification/validation is a plus.
• Experience in antibody-drug conjugates and bispecific antibodies is a plus
• Working knowledge of cGMP environment is a plus

Knowledge/Skills:

• In-depth knowledge of a broad range of analytical assays
• 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
• Excellent interpersonal, presentation, and written communication skills
• Creative thinker and complex problem solver

SUPERVISORY RESPONSIBILITIES:

• Directing work only (no direct reports, but directing work to a CMO, Consultant or 3rd party.)

WORKING CONDITIONS:

• Environment: primarily working in laboratories or in office
• Exposures encountered, such as hazardous materials, and extreme cold.
• Limited travel requirement

#LI-MB1

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 $125,000 - $176,500 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.