Exelixis, Inc.
PK Bioanalysis Director page is loaded## PK Bioanalysis Directorlocations:
Alameda, CAtime type:
Full timeposted on:
Posted Todayjob requisition id:
JR6402**SUMMARY/JOB PURPOSE****:**The Bioanalysis Director (BD) will manage outsourced regulated bioanalytical work for small molecules with LC-MS/MS in support of pharmacokinetic (PK) for nonclinical and clinical studies. They will possess strong technical expertise with LC-MSMS bioanalysis is essential. Knowledge of anti-drug antibodies (ADA) assay is preferred.**ESSENTIAL DUTIES/RESPONSIBILITIES:*** Lead outsourced bioanalysis and work with CRO to establish robust bioanalytical methods to support PK assays for nonclinical studies and clinical trials.* Review method validation and sample analysis plans, protocols, data and reports to ensure scientific integrity and compliance with regulatory requirements.* Serve as project manager for timelines, contracts, and budgets in support of outsourced projects.* Contribute to regulatory filings.**SUPERVISORY RESPONSIBILITIES:*** None.**EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:**Education:* BS degree in Chemistry or related field and a minimum of 13 years of relevant work experience; or,* MS degree in Analytical Chemistry or related field and a minimum of 11 years of relevant work experience; or,* PhD degree or equivalent in Analytical Chemistry or a related discipline and a minimum of 8 years of relevant work experience; or,* Equivalent combination of education and experience.Experience:* Experience/expertise in regulated bioanalysis and clinical-stage programs.* Knowledge and experience in GLP/GCP requirements.* Experience with LC-MSMS methods for small molecules, experience with ADA assays is a plus.* Prior experience and good understanding of the regulatory requirement for method validation and sample analysis for PK and immunogenicity.* Experience in managing CRO-outsourced bioanalysis.* Experience with project management.**Knowledge, Skills and Abilities:*** Applied knowledge and expertise with GLP and GCP regulations.* High level of expertise in bioanalytical methods and technology platforms. Experience with LC-MSMS methods and immunoassays.* Proficiency with Microsoft office software (Word, Excel, PowerPoint) and Watson LIMS.* Detail-oriented, good organizational, documentation and technical writing skills.* Able to work collaboratively with people from a broad range of business functions.* Excellent interpersonal, organization and communication skills.* Applies working knowledge of scientific, technical and quality management principles to solve problems (assays, processes, equipment, etc.).* Work on a diverse scope of problems including scientific, technical and compliance.**Work Environment/Physical Demands****:**Our office is a modern, open-plan space that foster collaborations 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.#LI-HG1*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 $163,000 - $232,000 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.***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. #J-18808-Ljbffr
Alameda, CAtime type:
Full timeposted on:
Posted Todayjob requisition id:
JR6402**SUMMARY/JOB PURPOSE****:**The Bioanalysis Director (BD) will manage outsourced regulated bioanalytical work for small molecules with LC-MS/MS in support of pharmacokinetic (PK) for nonclinical and clinical studies. They will possess strong technical expertise with LC-MSMS bioanalysis is essential. Knowledge of anti-drug antibodies (ADA) assay is preferred.**ESSENTIAL DUTIES/RESPONSIBILITIES:*** Lead outsourced bioanalysis and work with CRO to establish robust bioanalytical methods to support PK assays for nonclinical studies and clinical trials.* Review method validation and sample analysis plans, protocols, data and reports to ensure scientific integrity and compliance with regulatory requirements.* Serve as project manager for timelines, contracts, and budgets in support of outsourced projects.* Contribute to regulatory filings.**SUPERVISORY RESPONSIBILITIES:*** None.**EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:**Education:* BS degree in Chemistry or related field and a minimum of 13 years of relevant work experience; or,* MS degree in Analytical Chemistry or related field and a minimum of 11 years of relevant work experience; or,* PhD degree or equivalent in Analytical Chemistry or a related discipline and a minimum of 8 years of relevant work experience; or,* Equivalent combination of education and experience.Experience:* Experience/expertise in regulated bioanalysis and clinical-stage programs.* Knowledge and experience in GLP/GCP requirements.* Experience with LC-MSMS methods for small molecules, experience with ADA assays is a plus.* Prior experience and good understanding of the regulatory requirement for method validation and sample analysis for PK and immunogenicity.* Experience in managing CRO-outsourced bioanalysis.* Experience with project management.**Knowledge, Skills and Abilities:*** Applied knowledge and expertise with GLP and GCP regulations.* High level of expertise in bioanalytical methods and technology platforms. Experience with LC-MSMS methods and immunoassays.* Proficiency with Microsoft office software (Word, Excel, PowerPoint) and Watson LIMS.* Detail-oriented, good organizational, documentation and technical writing skills.* Able to work collaboratively with people from a broad range of business functions.* Excellent interpersonal, organization and communication skills.* Applies working knowledge of scientific, technical and quality management principles to solve problems (assays, processes, equipment, etc.).* Work on a diverse scope of problems including scientific, technical and compliance.**Work Environment/Physical Demands****:**Our office is a modern, open-plan space that foster collaborations 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.#LI-HG1*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 $163,000 - $232,000 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.***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. #J-18808-Ljbffr