Senior Scientist I (CMC Analytical) - #100274

Exelixis


Date: 04/19/2022 20:00 PM

City: Alameda, California

Contract type: Full Time

Work schedule: Full Day

Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Job Description

Responsible for small molecule analytical drug substance and drug product development related activities, both clinical and commercial, including method transfers, method development, method validation, method troubleshooting, analytical data review for release and stability, stability trending and reference standard certifications. Occasional in lab method development and troubleshooting skills required. Other duties may include project management, CMO oversight and CMC regulatory document authoring. 

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES: 
•    Manage analytical chemistry activities both internally and at contract laboratories with best practices of development and commercial.
•    Partner closely with contract labs to directly oversee transfer of methods, validation, and QC testing to ensure they are executed successfully and with best practices.
•    Provide oversight for release and stability testing of clinical and commercial batches for small molecule drug substance and drug product.
•    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, shelf-life/retest dating, using where applicable, current regression analysis practices and other relevant statistical techniques.
•    Author analytical sections of CMC submissions in support of regulatory filings. 
•    Identify and draft work instructions/SOP for relevant analytical functions.

SUPERVISORY RESPONSIBILITIES:
•    No supervisory responsibilities

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: 
Education:
•    BS/BA degree in Analytical Chemistry or related discipline and a minimum of twelve years of related experience; or,
•    MS/MA degree in Analytical Chemistry or related discipline and a minimum of ten years of related experience; or,
•    Ph.D. degree in Analytical Chemistry or related discipline and zero or more years relevant experience.

Experience:
Experience in Biotech/Pharmaceutical industry preferred.
•    Strong GMP and Regulatory compliance experience. 
•    Experienced in ICH stability implementation and data trending analysis.

Knowledge/Skills:
•    Must have extensive knowledge and hands-on experience with analytical instruments including HPLC, LCMS, GC, and Dissolution
•    Knowledgeable in ICP-MS/IPC-OES, DSC, DVS and XRPD techniques are a plus. 
•    Familiarity with the solid oral dosage forms is a plus.
•    Must have strong attention to detail, excellent communication skills, good organizational skills, and multitasking abilities.
•    Strong knowledge in analytical chemistry and cGMP/GLP, FDA, Ph Eur, ICH guidelines and regulations. 
•    Extensive knowledge of varying stages of development, from preclinical to Phase III to commercialization, such as analytical technology transfer, analytical support for process validation (API and drug product), ICH stability, specifications, participation in meetings with regulatory agencies, etc. is highly desirable.
•    In-depth understanding of the compendial requirements such as the USP, Ph Eur, JP 
•    Familiar with ICH, FDA and EU requirements and guidance.
•    Good investigative skills and ability to troubleshoot methods remotely. 
•    Manage and contribute to CMO deviations and CAPAs to ensure that they are properly investigated and documented. Track CAPAs to ensure they are effectively implemented.
•    Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
•    Has good general knowledge of other related disciplines.
•    Applies strong analytical and business communication skills.

WORKING CONDITIONS:
•    Environment: primarily working in laboratories or in office
•    Travel required – 10% of travel required for the oversite of CMO laboratory facilities  

#LI-BC1

Additional Information

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.

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