Job description

Bioanalysis Director

SUMMARY/JOB PURPOSE:

The Bioanalysis Director (BD) will manage GxP-compliance in bioanalytical work for pharmacokinetic (PK), anti-drug antibodies (ADA), and biomarkers in support of nonclinical and clinical studies. BD will manage CRO-outsourced bioanalysis for small molecules and biologics and provide project management support for external and internal projects. BD will partner with other functional leaders in Quality Assurance, Compliance, Quality Management & Biosamples (QMB) to ensure project quality and timely delivery.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Manage a GxP-compliant Bioanalytical Lab and support Lab Operations & Processes
Manage critical reagents inventory/shipments, study samples custody/logistics and analytical instruments maintenance/validation
Lead GxP-compliance for PK, ADA, and biomarker bioanalysis for nonclinical and clinical trials
Serve as GxP SME and group representative for interactions with QA, QMB, EHS and CROs
Author and review standard operating procedures (SOP), qualification/validation protocols and bioanalytical reports
Manage and oversee CRO-outsources bioanalysis of small molecules and antibody-drug candidates (ADCs)
Serve as project manager for timelines and budgets in support of internal and outsourced projects
Contribute to regulatory interactions and filings

SUPERVISORY RESPONSIBILITIES:

Will supervise 1 or 2 direct reports

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

BS degree in biological science or related field and a minimum of 13 years of relevant work experience; or,
MS degree in biological science or related field and a minimum of 11 years of relevant work experience; or,
PhD degree or equivalent in biological science or a related discipline and a minimum of 8 years of relevant work experience; or,
Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Experience/expertise in regulated bioanalysis and clinical-stage programs
Knowledge and experience in GLP/GCP requirements and practices in bioanalytical lab
Experience with LCMS methods for small molecules and ADCs, experience with hybrid-LCMS is plus
Prior experience and good understanding of the regulatory requirement for method development and validation for PK, immunogenicity and biomarkers
Experience in managing CRO-outsourced bioanalysis
Experience with project management
Experience with regulatory interactions is a plus

Knowledge/Skills:

Applied knowledge and expertise with GLP and GCP regulations
High level of expertise in bioanalytical methods and technology platformsExperience with immunoassays and LCMS methods
Proficiency with Microsoft office software (word, excel, power point) and graphical computer programs (e.g., GraphPad, etc.).
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

JOB COMPLEXITY:

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, operational and compliance
Must be able to function under minimum supervision

#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 $160,000 - $226,500 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.

Alameda, CA

Posted 3 days ago

Product Development

Full time Regular

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SUMMARY/JOB PURPOSE:

The Bioanalysis Director (BD) will manage GxP-compliance in bioanalytical work for pharmacokinetic (PK), anti-drug antibodies (ADA), and biomarkers in support of nonclinical and clinical studies. BD will manage CRO-outsourced bioanalysis for small molecules and biologics and provide project management support for external and internal projects. BD will partner with other functional leaders in Quality Assurance, Compliance, Quality Management & Biosamples (QMB) to ensure project quality and timely delivery.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Manage a GxP-compliant Bioanalytical Lab and support Lab Operations & Processes
Manage critical reagents inventory/shipments, study samples custody/logistics and analytical instruments maintenance/validation
Lead GxP-compliance for PK, ADA, and biomarker bioanalysis for nonclinical and clinical trials
Serve as GxP SME and group representative for interactions with QA, QMB, EHS and CROs
Author and review standard operating procedures (SOP), qualification/validation protocols and bioanalytical reports
Manage and oversee CRO-outsources bioanalysis of small molecules and antibody-drug candidates (ADCs)
Serve as project manager for timelines and budgets in support of internal and outsourced projects
Contribute to regulatory interactions and filings

SUPERVISORY RESPONSIBILITIES:

Will supervise 1 or 2 direct reports

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

BS degree in biological science or related field and a minimum of 13 years of relevant work experience; or,
MS degree in biological science or related field and a minimum of 11 years of relevant work experience; or,
PhD degree or equivalent in biological science or a related discipline and a minimum of 8 years of relevant work experience; or,
Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Experience/expertise in regulated bioanalysis and clinical-stage programs
Knowledge and experience in GLP/GCP requirements and practices in bioanalytical lab
Experience with LCMS methods for small molecules and ADCs, experience with hybrid-LCMS is plus
Prior experience and good understanding of the regulatory requirement for method development and validation for PK, immunogenicity and biomarkers
Experience in managing CRO-outsourced bioanalysis
Experience with project management
Experience with regulatory interactions is a plus

Knowledge/Skills:

Applied knowledge and expertise with GLP and GCP regulations
High level of expertise in bioanalytical methods and technology platformsExperience with immunoassays and LCMS methods
Proficiency with Microsoft office software (word, excel, power point) and graphical computer programs (e.g., GraphPad, etc.).
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

JOB COMPLEXITY:

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, operational and compliance
Must be able to function under minimum supervision

#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 $160,000 - $226,500 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.