Sr Scientist I Analytical Development, Biologics CMC

SUMMARY/JOB PURPOSE:

The Senior Scientist Analytical Development Biologics CMC will support CMC analytical development for biologic therapeutics with a primary focus on protein characterization using high-resolution mass spectrometry and analytical assay development for antibody-drug conjugates (ADCs). The incumbent will apply deep technical expertise in mass spectrometry liquid chromatography and electrophoresis to perform assay development and product characterization and to advance pre-IND and clinical-stage biologics programs.

The individual is expected to work hands-on in the laboratory to develop optimize qualify and transfer analytical methods supporting internal CMC development activities and external CDMO/CTL execution. This role will support extended characterization of ADCs monoclonal antibodies bispecifics and other biologic modalities including intact and subunit mass analysis peptide mapping post-translational modification assessment sequence confirmation conjugation site analysis linker-payload related variant identification DAR-related characterization and chromatographic peak identification.

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:

• Serve as a subject matter expert for high-resolution mass spectrometry-based protein characterization of biologics including ADCs monoclonal antibodies bispecific antibodies and related novel biotherapeutic proteins.

• Develop optimize and execute LC-MS methods for intact mass reduced and non-reduced mass analysis subunit analysis peptide mapping PTM identification sequence confirmation disulfide mapping glycosylation assessment and product variant characterization.

• Lead or support assay development for biologics including methods such as SEC HIC RP-HPLC icIEF CE-SDS and residual-free drug analysis

• Support ADC-specific characterization including conjugation site analysis drug-antibody ratio distribution linker-payload related variants conjugatable impurities payload-related degradation products and process- or storage-related modifications.

• Perform method development and analytical testing to support upstream downstream bioconjugation and formulation process development.

• Transfer analytical methods from internal development to CDMOs/CTLs and provide technical oversight for method qualification validation and routine testing.

• Review and author analytical procedures SOPs protocols technical reports method qualification/validation documents and product characterization reports.

• Review GMP release and stability testing results and support OOS/OOT deviation change control and investigation activities related to analytical methods and product quality.

• Support CQA assessment and control strategy development by integrating analytical results from mass spectrometry chromatography electrophoresis biophysical characterization and functional assays.

• Support IND/IMPD and other regulatory submission activities including authoring and reviewing analytical development characterization method validation and control strategy sections.

• Collaborate closely with Process Development DS and DP Manufacturing Quality Assurance Regulatory Affairs Project Management Discovery external CDMOs CTLs and other partners.

• Contribute to building and maintaining internal laboratory capabilities for advanced biologics characterization including instrument operation maintenance troubleshooting and implementation of new technologies.

• Work independently and collaboratively in a fast-paced matrixed environment while delivering high-quality technical results and documentation.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:

• Ph.D. in chemistry biochemistry analytical chemistry pharmaceutical sciences chemical engineering protein chemistry or a related field with relevant industry experience; or

• Masters degree in chemistry biochemistry analytical chemistry pharmaceutical sciences chemical engineering protein chemistry or a related field with 5 years relevant industry experience; or

• Bachelors degree in chemistry biochemistry analytical chemistry pharmaceutical sciences chemical engineering protein chemistry or a related field with 7 years relevant industry experience; or

• Equivalent combination of education and experience.

• Experience:

• Demonstrated hands-on experience in protein characterization and structural elucidation using high-resolution mass spectrometry such as Orbitrap and Q-TOF is highly desired.

• Strong technical experience with LC-MS/MS workflows for intact protein analysis reduced/subunit analysis peptide mapping PTM analysis disulfide mapping glycan/glycopeptide analysis sequence confirmation and chromatographic peak identification is highly desired.

• Experience in analytical assay development for ADCs is strongly preferred including SEC HIC RP-HPLC icIEF CE-SDS DAR-related analysis and residual-free drug analysis.

• Experience in higher order structure analysis such as SEC-MALS DSC FTIR and CD is a plus.

Knowledge/Skills:

• In-depth knowledge of biologics analytical development protein chemistry mass spectrometry chromatography electrophoresis and CMC product characterization.

• Strong understanding of critical quality attributes for biologics and ADCs including size variants charge variants purity glycosylation PTMs sequence variants fragmentation aggregation conjugation-related attributes DAR-related species and linker-payload related variants.

• Ability to design scientifically sound studies interpret complex analytical data and translate findings into actionable CMC development decisions.

• Strong technical writing skills for protocols reports SOPs regulatory sections and investigation summaries.

• Ability to work effectively with cross-functional internal teams and external CDMOs/CTLs.

• Excellent communication presentation collaboration and problem-solving skills.

• Ability to prioritize multiple programs and deliver high-quality work in a fast-paced environment.

• Strong ownership scientific curiosity attention to detail and commitment to technical excellence.

SUPERVISORY RESPONSIBILITIES:

• No direct people management responsibility is required. The incumbent may provide technical guidance training and work direction to junior scientists research associates consultants CDMOs CTLs and other external partners

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 severalU.S. geographic markets and we pay differently based on those defined markets. The base pay range for this positionis $127500 - $180500 annually. The base pay range may take into account the candidates geographic region which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidates 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.

If you have a disability and need an accommodation in relation to the recruiting process please email us at: .

WORKING CONDITIONS:

Our office is a modern space that fosters collaboration and creativity. Teams work closely together sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment including dual monitors and ergonomic chairs to ensure a comfortable workspace.

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.