Reporting to the Head of Development Sciences and working closely with peer scientific leaders in Pharmacology, CMC, DMPK, Toxicology, QA, and Regulatory functions of Organization, the Director, Bioanalytical Sciences will be accountable for setting up the Bioanalytical strategy and tactical planning along with standard operating procedures, and for the outsourcing, in-house and external execution, monitoring, and reporting of the non-GLP and GLP nonclinical bioanalytical assays (BA) supporting Absorption, distribution, Drug metabolism/ pharmacokinetics (ADME/PK), authoring content for the Bioanalytical components of regulatory submissions, and responding to information requests by Global health authorities and partners for the company’s portfolio of molecules in development.
- Conceptualize, and operate hands-on in-house BA laboratory activities
- Supervise, manage, and strategic planning with BA CROs on objectives and priority setting to deliver robust and reliable bioanalytical assays.
- Lead development and technology transfer of BA methods to CROs in US and externally.
- Lead scientific review and provide instruction on bioanalysis from CROs for CRO to provide quality data/reports within specified timelines.
- Evaluate work from the internal bioanalytical staff, CROs, contractors, and consultants.
- Organize project meetings and manage timelines for coordinating BA and CRO work.
- Represent the bioanalytical group to present bioanalytical results to project teams.
- Responsible for review and approval of data/report from both BA and CRO labs in coordination with the CRO Study Monitors.
- Contribute to the preparation of bioanalytical sections of IND/BLA documents.
- Contribute to addressing questions and inspections from the regulatory agencies.
- Provide bioanalytical input and collaborate across all functional areas, including research, preclinical, clinical development, project management, biostatistics, data management, and regulatory affairs departments.
- Develop a vision for an analytical function of a growing organization and effectively communicate a supporting strategy to align people, resources and management.
- Professionally network with bioanalytical scientists in other pharmaceutical companies to be current with standard practices and regulatory issues facing bioanalytical development.
- Integrate quality standards to ensure data of the highest quality (e.g. GLP and GCLP compliance, accuracy, precision).
- A minimum of 10 years of industry experience in conducting bioanalytical research and development, validation, and sample analysis for nonclinical assays.
- Expert in the bioanalytical application of gas chromatography, liquid chromatography, and mass spectrometry for small molecules compounds, proteins and carbohydrates.
- At least 3 yrs of experience leading & managing a bioanalytics within a corporate setting.
- Experience in the application of high throughput and automated approaches for bioanalytical support.
- Persuasive written and oral communications skills.
- Demonstrate success in technical proficiency, scientific creativity, and collaboration with others and independent thought.
- Scientific know-how: widely recognized as an expert that maintains high level of professional expertise through familiarity with scientific literature.
- This candidate should be a driver of innovative bioanalytics research and development.
- The individual will be a self-starter with excellent time and people management capabilities and who is seeking to be a critical part of and to help lead cross functional teams to support the company’s drug development process.
- Doctoral degree (PhD) in biology, biochemistry or relevant discipline.
- Proficient in the use of Microsoft Word, Excel and PowerPoint.
- Familiarity with LIMS systems.
- Title commensurate with experience and fit.
EEO & Employment Eligibility
TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.