Associate Director, BioAnalytics (can be remote NJ, CA, PA)
We are seeking an Associate Director of Bioanalytical to contribute to the success of a clinical-stage biotechnology company developing first-in-class immunology therapeutic product candidates for patients. We are focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications. The Associate Director will be responsible for developing and implementing pharmacokinetic, immunogenicity and biomarker assays in support of large-molecule drug development. The incumbent will serve as a scientific expert and leader in bioanalysis for the organization and will oversee technical and regulatory strategies for the implementation of bioanalytical assays for nonclinical and clinical development programs. (Can be remote NJ, CA, PA)
· Design and develop of all aspects of preclinical and clinical bioanalysis including de novo assay development, optimization, and troubleshooting
· Support all bioanalysis efforts for preclinical and clinical studies, including biological activity, pharmacokinetic, pharmacodynamic/biomarker, and immunogenicity analysis
· Serve as a bioanalytical representative in nonclinical and clinical teams as needed
· Manage CRO relationships, processes, including method development/transfer, optimization, validation, critical reagent supply and assay lifecycle management; enable stage-appropriate bioanalytical support for internal and external partners and programs
· Develop, qualify, and transfer PK, ADA and biomarker assays to bioanalytical CROs
· Review, present and report results to internal/external teams and in internally authored technical reports
· Design, author and review method validation plans, method qualification and validation reports, sample analysis plans and bioanalytical study reports
· Develop operational work plans including requests for proposals/quotes, tracking of project milestones, timelines, develop risk mitigation strategies and technical troubleshooting
· Manages and maintains equipment, reagents and dedicated laboratory environment needed to carry out assignments
· Follows internal SOPs and ensures CROs are following current regulatory guidance in the development, validation and execution of GLP bioanalytical assaysRequirements
· PhD with 8+ years or MS with12+ years in a relevant life science discipline and having experience in the biopharmaceutical industry, preferably in large molecule drug development
· 5+ years managing CROs
· In-depth experience in ligand binding assay development (e.g. ELISA, ECL/MSD)
· Knowledge of assay development and validation, and understanding GXP requirements and ICH guidelines to support the regulatory approval process
· Experience authoring reports/presentations/communication bullet
· Experience within a fast-paced biotech environment
• Hands-on experience with pharmacokinetics, pharmacodynamics, and immunogenicity assay development and validation of biotherapeutics
• Excellent organizational and project management skills required for extensive interactions with multiple CROs and external study monitoring responsibilities.
• Experience with whole blood and primary cell assays.
Key Leadership Competencies:
• Independently builds strong relationships with peers, cross functionally teams and with partners to enable delivering on timelines and team goals.
• Demonstrates strong oral and written communication skills, teamwork, and attention to detail.
• Creates a learning environment, open to suggestions and experimentation for improvement.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate. This role may require traveling by plane or car. This position requires working with biological and/or chemical hazards
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.