Sr Scientist II (Analytical Development Small Molecule))

SUMMARY/JOB PURPOSE:

The incumbent will be responsible for the day-to-day activities directed toward the development and validation of analytical methods for the testing of Exelixis Investigational New Drug Substances and New Drug Products.The activities will include, but not limited to, laboratory support to CMC development, CDMO oversite, hands-on data and documentation review; contributing to deviations, investigations and CAPAs; providing guidance on extended product characterization and comparability assessments; authoring and reviewing relevant CMC submissions.The incumbent will also be responsible for the transfer of methods to contract laboratories and manage analytical related activities at contract laboratories, including release testing, stability studies, OOT/OOS investigations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Work closely with DS or DP Lead and provide analytical support to process development and manufacturing: timely method development and validation, impurities analysis and mapping, and phase-appropriate specification and control strategies.

• Design, plan and execute experiments to support project goals including, but not limited, method development, method understanding, investigation and troubleshooting.

• Manage analytical development activities both internally and at contract laboratories with best practices in support of Exelixis pharmaceutical development from discovery to NDA.

• Contribute effectively towards strategic and tactical development of project plans with emphasis on analytical aspects and phase appropriate development.

• Provide expertise of various analytical techniques to help CMC development: HPLC/UPLC (reversed phase and chiral), GC, LCMS, FTIR, NMR, KF, XRPD, PSD, TGA, DSC, Peptide Mapping, etc.

• Provide strategic and tactical inputs toward assessing and identifying any at risk or potential problematic areas within analytical testing activities at CDMOs and provide effective solutions to mitigate before these areas result in any issues.

• Perform hands-on documentation and data review and provides significant contributions and oversight to contract labs for protocols, deviations, investigations, CAPA's, reports, stability data, trending, specification setting, shelf-life/retest dating, using, where applicable, current regression analysis practices and other relevant statistical techniques.

• Work closely with contract labs to directly oversee transfer of methods, validation, and QC testing to ensure they are executed successfully and with best practices.

• Author, prepare and review relevant sections of CMC submissions in support of regulatory filings.

• Collaborate effectively within CMC and with QA and RA and outside contract laboratories with excellent communication to maintain strong relationships.

• Stay current with changing regulatory requirements regarding analytical testing.

• Help to identify and draft work instructions/SOP for relevant analytical functions.

• Train junior scientists

SUPERVISORY RESPONSIBILITIES:

• Operates independently to achieve goals and objectives established by projects teams and management.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

• Ph.D. in Analytical Chemistry or a related field and a minimum of 2 years of related experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal Candidate will have:

• Hands-on experience and solid understanding of high-resolution technologies, such as QTof, QQQ, and Orbitrap, and their use in structural elucidation of impurities are highly desired.

• Experience in drug-linker technology and chemistry is a plus.

• Hands-on experience in analytical development in the pharmaceutical industry.

• Experience in developing and validating analytical methods, specifically reversed phase HPLC/UPLC methods, chiral methods, GC methods, and LCMS methods, for testing small molecule drug substances and drug products.

• Experience of conducting stability programs.

• Experience of working with contract laboratories is also highly desirable.

• Hands-on experience and in-depth knowledge with instrumentation software such as Empower, MassLynx, ChemStation, JMP, etc.

• In-depth knowledge of Good Manufacturing Practices (GMP) and FDA/ICH and EU regulations and guidelines.

• Experience in regulatory filings, such as IND, IMPD and NDA

• Critical thinker with demonstrated ability to take initiative and work independently.

• Team player with capability to work within a team in a fast-paced environment.

• Experience in managing small groups of scientists.

• Ability to communicate clearly and effectively, both verbally and in writing.

• Detail oriented, data-driven, and self-motivated.

Knowledge/Skills:

• Comprehensive knowledge of regulatory and compliance issues as they relate to the development of pharmaceutical products.

• Excellent written and oral communication skills.

• Team player with capability to work within a team and as an individual contributor in a fast-paced environment.

• Detail oriented, data-driven, and self-motivated

WORKING CONDITIONS:

Pharmaceutical Operations & Supply Chain/Alameda:

• Environment: working both in laboratories and in office.

• Travel as required (to be less than 20%).

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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.