The successful candidate will join an industry leading Regulated Bioanalytical group to support biotherapeutic projects in the portfolio pipeline. Responsibilities include managing activities required to maintain regulatory compliance of multiple assay platforms (e.g. ligand binding, cell-based, PCR) utilized for the measurement of drug concentration, immunogenicity, and vector/transgene biodistribution in various biological matrices. With deep knowledge of both the bioanalytical discipline and regulatory guidance (GLP, GCLP), the successful candidate will be an active team member driving the overall quality and compliance of the Regulated Bioanalytical group.Responsibilities
- Oversee quality and compliance of the Regulated Bioanalytical (Reg BA) group to maintain high level of regulatory compliance and inspection readiness.
- Work in close collaboration with bioanalytical quality management (BQM) leadership on optimization and implementation of quality and compliance infrastructure.
- Acquire deep knowledge of departmental processes and system applications to conduct in-depth quality control (QC) and compliance reviews of study data and documentation generated for the assay development, validation, and implementation of robust and reliable assays per department SOPs and regulatory guidance.
- GLP and GCP study reviews to include all aspects of the sample life cycle from receipt through final disposition per department SOPs and GLP/GCLP guidelines.
- Mentor bioanalytical staff on comprehensive study documentation and corrective and preventative actions (CAPA) strategy.
- Organize and drive successful routine internal audits and external inspections.
- Work in close collaboration with departmental management and Quality Assurance to manage CAPA.
- Lead continuous process improvement with regular monitoring and review of compliance metrics and CAPA with Reg BA group.
- Perform reviews with a high degree of independence and under challenging timelines to support project deliverables.
- Support activities for oversight of regulated infrastructures (QC, sample coordination, and instrument validation and maintenance).
- BSc with 9+ or MSc with 6+ years or PhD with 3+ years relevant experience
- Background working in GLP, GCLP environment is required.
- Expertise across multiple assay platforms (ligand binding, cell based, PCR).
- Demonstrated track record as a study bioanalytical principal investigator with knowledge of assay development and validations supporting biotherapeutics.
- Experience in QC and investigation of quality events and CAPA process.
- Direct experience with inspection readiness and audit conduct of regulated bioanalytical laboratory.
- A detail-oriented, self-motivated individual with flexible approach and team-oriented work style will be critical to the success of the candidate.
- Ability to excel in a collaborative, fast paced and dynamic environment is essential.
- Excellent organizational and communication skills.
Other Job Details
- Experience outsourcing regulated bioanalytical support to external vendors is a plus.
- Knowledge of hybrid and/or nanoflow LCMS biomarker assays.
- Eligible for Employee Referral: YES
- Eligible for Relocation Assistance: YES
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Research and Development