Job Description
The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Department is seeking a Director to lead our Regulated Bioanalytics Sample Management group, which is based at our WP and Springhouse, PA sites, but also has oversight of related staff and processes in Germany. At these facilities, our sample management teams support the receipt and distribution of study samples and reagents for our Regulated Bioanalytics organization, which develops/validates/implements bioanalytical methods to generate pivotal study results for small molecule, biotherapeutic, and vaccine candidates in non-clinical through clinical phases of development.
The individual will be responsible to lead all aspects of sample management operations across our West Point, PA, Springhouse, PA, and Schwabenheim, Germany facilities, while building strong relationships with clinical operations and other global staff to drive study improvements from clinical sites through the reporting of bioanalytical data. The individual will also support efforts to implement and enhance Laboratory Information Management Systems (LIMS) or other applications used by the team. The candidate should be current on state-of-the art technologies and is expected to champion evaluation of new technologies and optimize processes. Representing the lab during quality and regulatory audits will be required.
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Education Minimum Requirement
- B.A./B.S. in Biology, Molecular Biology, Chemistry, Biochemistry, Engineering, Biotechnology, or related discipline with at least 15 years, M.S. with at least 10 years, or Ph.D. with 8 years experience in a related field
Responsibilities
- Manage the development, implementation, operation, and troubleshooting of automation solutions (e.g., sample stores, liquid handlers) within the sample management laboratory that addresses the receipt, aliquoting, and storage of regulated clinical samples and reagents
- Recruit and develop a global sample management team and provide coaching and mentorship to grow talent to sustain our current and future pipeline
- Develop and sustain strong relationships with clinical operations and drive process improvements that may occur starting at the clinical site, through the receipt, testing, and reporting of sample results
- Lead staff through automated and manual sample receipt, processing, aliquoting, and distribution, ensuring efficiency and quality in sample management operations
- Evaluate and validate new or updated applications (e.g., LIMS, automation systems) that enable improved sample management processes
- Partner with IT on interfacing sample management automation data and systems into LIMS or other inventory management applications
- Serve as an internal subject matter expert on new and existing automated liquid handler and automated samples store technology and capabilities
- Author SOPs or job aids associated with sample management systems and processes
- Perform responsibilities in compliance with departmental SOPs and regulatory guidances (e.g., GxP)
- Serve as lab lead during internal or external regulatory audits
- Develops priorities and objectives for the sample management team to align with division scorecard
Required Experience & Skills
- Experience leading sample management staff within a GxP regulated lab
- Experience working with lab automation, such as liquid handlers, robotics, or automated sample stores
- Experience implementing and validating new or updated lab applications such as a laboratory information management systems (LIMS) or related systems
- Strong verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators
- Ability to communicate effectively in presentations to stakeholders in partner organizations, to write technical reports, and to participate on cross-functional teams
- Ability to build and maintain strong relationships with site leaders, corporate management, and other stakeholders to ensure effective communication of plans and issues
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
- Ability to prioritize projects and resources to deliver required level of output and support
- Ability to lead, mentor, and inspire team members at various levels; encourages curiosity in others and challenges the status quo to foster innovation
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Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
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Job Posting End Date:
12/26/2024
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Requisition ID:R327627