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SUMMARY/JOB PURPOSE:
The Sr. Scientist II is responsible for supporting laboratory activities related to small molecules -ADC drug-linkers, drug substance and drug product programs including method transfers, method development, method validation, method troubleshooting, analytical data review for release and stability, stability trending and reference standard certifications. The Scientist will develop and execute analytical methods, interpret data supporting the characterization of small molecule drug linker intermediates, drug substances and drug products.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Plans and executes experiments supporting development activities and project goals.
Selects appropriate analytical methods and techniques to support process development.
Troubleshoots analytical methods and lab instrumentations.
General maintenance of Analytical laboratory for small molecules
Performs physical and chemical characterization of drug substances and drug products.
Process and interprets data.
Collaborates with supervisory personnel to develop methods.
Perform data analysis and evaluate quality of data.
Develops subject matter expertise in an analytical technique and acts as a resource for other employees within the department.
Coordinates and monitors specific method development activities or studies within a larger project.
Authors reports, protocols, test methods, and other documentation.
Perform technical review of release and stability data (including raw test data) to ensure compliance with all established and approved analytical procedures.
Review results transcribed to data tables, protocols, and reports to ensure accuracy.
SUPERVISORY RESPONSIBILITIES:
None
EDUCATION/EXPERIENCE/SKILLS:
Education:
BS/BA degree in Analytical Chemistry or related Sciences and a minimum of seven years of related experience; or,
MS/MA degree in Analytical Chemistry or related Sciences and a minimum of five years of related experience; or,
PhD degree in Analytical Chemistry or related Sciences and zero or more years of related experience; or,
Equivalent combination of education and experience.
Experience:
7-10 years of related experience and/or combination of experience and education/training.
Hands-on proficiency and problem-solving skills with HPLC/UPLC, LC-MS, ICP-MS/IPC-OES, GC, FTIR, KF and dissolution or other analytical techniques.
Knowledgeable in DSC, DVS, PSD and XRPD techniques is a plus.
Experience reviewing raw data and documents generated in an analytical test laboratory is preferred.
Technical hands-on laboratory experience in small molecules and solid oral dosage is preferred.
Good investigative skills and ability to troubleshoot methods.
Experience with Instrumentation software such as Empower, ChemStation, etc.
Knowledge/Skills/Abilities:
Proven ability to manage multiple assignments and effectively complete all expected deliverables in a timely manner.
Knowledge of Good Manufacturing Practices and FDA/ICH and EU regulations and guidelines.
Extensive knowledge of varying stages of development such as analytical technology transfer, analytical support for process validation, ICH stability, specifications, etc. is highly desirable.
Ability to communicate clearly and effectively, both verbally and in writing.
Must have strong organizational skills and be detail oriented.
Demonstrate ability to take initiative and work independently.
Capability to work within a team and as an individual contributor in a fast-paced environment.
Experience with Microsoft Office (Word, Excel, Power Point, etc.).
WORKING CONDITIONS:
Environment: primarily working in laboratories or in office.
Travel may not be required.
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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 $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.