PK Bioanalysis Director

PK Bioanalysis Director page is loaded## PK Bioanalysis Director locations:
Alameda, CAtime type:
Full time posted on:
Posted 11 Days Agojob requisition :
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 several

U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $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  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…