Bioanalytical Project Manager/Principal Investigator – Direct Hire/Will Relo
Our client, a leading bioanalytical services contract research organization (CRO) that serves the pharmaceutical and biotech industries, is actively recruiting for a highly skilled and knowledgeable Bioanalytical Scientist to assume key role on its Client Services team.
This is one of the fastest growing companies in the Triangle. It specializes in large molecule bioanalysis and provides lab support services from early discovery through pre-clinical studies and clinical phases.
This Bioanalytical Project Manager/Principal Investigator (BPM/PI) will lead client projects from a scientific, client relations and team leadership perspective. This is a critical role and Company will pay excellent wage, including relo support, to attract and retain an excellent candidate.
Key Things to Note:
- This BPM/PI will drive the scientific elements of client projects and must be an expert in experimental planning and design for large molecule bioanalytics (techniques and tools highlighted below)
- Role will also involve client management, people management and project management. Right candidate will be a top-notch scientist with complementing skills in all three functions. Some bkgd working in CRO, CTL, or similar service provider will be important.
- This lab is GxP-compliant and substantial experience with related reg’s and practices will be essential.
- This is an emerging company with a collaborative work dynamic and a strong client service orientation. Priorities shift regularly and the pace is fast. Seek leader who enjoys that dynamic energy and will thrive despite change, disruption and interruption.
- Develop and validate biomarker, cell-based, immunogenicity, immuno- and enzymatic assays for support of preclinical, clinical and product release studies
- Partner with clients to assure successful on time execution of assays, validation and sample analysis
- Design and execute experiments efficiently – including the oversight of staff conducting experiments
- Ensure client programs meet company, client, and regulatory requirements
- Provide appropriate coaching, direction and recognition to team members.
- Plan, prioritize, and manage workload for client projects
- Serve as the scientific point of contact for the client
- Ensure compliance with documentation standards including LIMS upkeep
- Present data and posters
- Perform statistical analysis
- Write reports and prepare SOPs
Selected candidate will offer a scientific degree (advanced degree preferred) in the areas of molecular biology, biochemistry, immunology, biotechnology, or related field as well as 10+ years of experience in a scientific laboratory environment with a specialization in large molecule bioanalysis. 3+ years in industry, including experience working in a client support role, is essential.
Other priorities include:
- Expertise in the development and validation of biomarker, cell-based, immunogenicity, immuno- and enzymatic assays
- Significant experience with most of the following immunoassay platforms: ELISA, MSD-ECL, RIA, DELFIA, HTRF, and AlphaScreen
- Knowledge and application of regulatory guidance to experimental planning and design
- Finetuned project management skills including the development and management of timelines, deliverables and budgets
- Exceptional people management and development skills, including the supervision of senior level scientists
- Demonstrated knowledge of GxP regulations and best practices
- Facility with LIMS systems and optimizing their application
- Impact and longevity in previous roles
Finally and importantly, we seek a candidate who will work exceptionally well in this fast-paced, client driven setting. Outstanding scientific knowledge and know-how must be complemented by exceptional communication skills, business savvy and the ability to garner the cooperation and respect of internal and external stakeholders in order to achieve shared success.
This is an immediate need. Please forward Word resume for prompt consideration.