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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 with emphases on Bioconjugation/linker technology. The activities would include but not limited to CMO oversite, hands-on documentation review, contribute to deviations, investigations and CAPAs, provide guidance on product extended characterization and comparability assessments, author and review 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 stability studies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Manage analytical development activities both internally and at contract laboratories with best practices in support of Exelixis developmental from discovery to NDA .
Contribute effectively towards strategic and tactical development of project plans with key emphasis on analytical aspects and phase appropriate development.
In depth understanding of analytical methods for small molecule and biologics development: SEC, CE, cIEF, ELISA, LC-MS, Peptide Mapping.
Provide strategic and tactical input toward assessing and identifying any at risk or potential problematic areas within analytical testing activities at CMOs, 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, 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
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 two years of related experience; or,
Equivalent combination of education and experience.
Experience/The Ideal Candidate will have:
Experience in drug linker technology and chemistry is a huge plus.
Experience in Analytical Development in the pharmaceutical industry
Experience developing and validating analytical methods, specifically HPLC methods, for testing small molecule and biological drug substances and drug products.
Experience conducting stability programs
Experience working with contract laboratories is desirable
Hands on experience with analytical instrumentation including HPLC and GC
Knowledge/Skills:
Comprehensive knowledge of regulatory and compliance issues as they relate to the development of pharmaceutical products
Excellent written and oral communication skills
Ability to work effectively in a team setting
WORKING CONDITIONS:
Pharmaceutical Operations & Supply Chain/Alameda:
Environment: primarily working in office with occasional supervisory in laboratory environment
Travel as required (to be less than 20%)
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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 severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $119,500 - $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.