| Position Summary: The Senior Manager of Clinical Pharmacology, Biologics and Bioanalysis Department is seeking a highly motivated individual with strong GLP bioanalysis experience to join the bioanalytical group as a Sr Manager. The manager is responsible for oversight of the laboratory and team, application of GLP practices to pre-clinical laboratory testing, GxP application with clinical and other laboratory testing, review and application of SOPs, and oversight of projects outsourced to CROs. The job also oversees development and validation of qualitative and quantitative immunoassays designed to detect drug substances, anti-drug antibodies, and pharmacodynamic biomarkers in biological matrices, as well as the bioanalysis of samples using these assays. This position may also serve as a Principal Investigator (PI) or oversee individuals within the group which are serving the PI role. Major Duties and Responsibilities - Oversee the development, validation and bioanalysis of pre-clinical or clinical samples for the determination of drug, anti-drug antibodies, and biomarkers in biological matrices in support of preclinical and clinical studies.
- Responsible for the GXP compliance of the laboratory and staff. Monitor compliance of the laboratory, assure personnel are trained and equipment/systems validated. Develop and review SOPs and procedures to maintain/improve GXP environment and quality systems. .
- Supervise staff. Schedule work and prioritize projects in collaboration with senior management. Assure resources are available to support bioanalytical needs. Mentor and contribute to career development of lab personnel.
- Identify issues that may impact compliance, lab performance, deliverables and/or timelines and communicate/work across teams to address.
- Execute and provide significant input into the development, planning, and design of experiments, and interpretation of experimental results. Monitor methods through life cycle of program and implement changes as needed to maintain compliance and to meet study/program needs. Monitor assay performance and implement corrective and preventative measures as needed to maintain high level performance
- Maintain integrity for all study data through review of and approval of protocols, reports, data and study deviations.
- Coordinate assay transfers, establish, monitor and review validation studies with contract laboratories.
- Present results at internal and external meetings.
- Propose changes for improvement of compliance/efficiency/scientific integrity and collaborate across teams to implement and harmonize.
- Function as Responsible Bioanalytical Scientist in support of various GLP studies. Coordinate, implement and monitor performance metrics of bioanalytical CROs.
Requirements/Qualifications: Degree Required: BS: 13-15 years of relevant experience; MS: 10-13 years of relevant experience; PhD 3-7 years of relevant experience Special Skills/Abilities: - Management experience, including ability to independently manage individual work and that of the entire team, conducting performance reviews and assessments of team and application to the larger organizational structure
- Knowledge and extensive experience in GLP requirements and practices in bioanalytical lab, including but not limited to application of MSD and ELISA technology
- Experience and understanding of regulatory requirements for method development and validation for PK, immunogenicity (ADA), and PD biomarkers, along with regulatory interactions
- Strong expertise in immunoassay development, validation, and troubleshooting in support of biologic drug development
- Demonstrated ability for scientific insight and conceptual thinking in development of strategic drug development programs
- Detail oriented, good organizational, documentation and technical writing skills.
- Excellent interpersonal, organization and communication skills
- Ability to work in a team environment.
- Large Molecule experience preferred
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