Director - Bioanalytical Sciences
- Employer
- Adcentrx Therapeutics Inc.
- Location
- San Diego, CA
- Start date
- May 18, 2022
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- Discipline
- Engineering, Biomedical Engineer, Chemical Engineer, Science/R&D, Bio-Assay Development, Bioengineering
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Beach
Responsibilities:
• Leads Adcentrx Bio-analytical science to support non-clinical and clinical projects, including PK, ADA and biomarker assay development, validation and sample testing for company antibody- based therapeutics.
• Establish bioanalytical capabilities for assessment of drug pharmacokinetic (PK) pharmacodynamic (PD), immunogenicity, biomarkers and characterization of drug mechanism of action
• Lead development, qualification, and validation of PK, ADA and biomarker assays to support non-clinical and clinical studies
• Manage and oversee CRO outsourcing studies
• Lead generation and life cycle management of critical reagents for assays supporting required bio-analytical studies
• Author and review Standard Operating Procedures (SOP), validation and bioanalytical study protocols and reports and contribute to IND and BLA filings
• Mentoring and supervising direct reports
Qualifications:
• PhD degree in life science or related field with 8+ years relevant experience working in bio- analytical field
• Strong background in PK, ADA and biomarker assay development for biologics
• Scientific and technical expertise in assay design, validation and implementation
• Experience in bio-analytical studies supporting antibody-drug conjugate (ADC) development preferred
• Experience working under GLP regulatory environment and preparing corresponding sections for IND/BLA submission
• Strong communication and leadership skills, cross-functional team leadership abilities required
• Experience working in startup environments or fast-paced companies in competitive markets highly desirable
Adcentrx Therapeutics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the lives of our employees and their families. Benefits include medical, vision and dental coverage, 401(k), company paid holidays, and stock options. Adcentrx Therapeutics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.Get job alerts
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