Associate Director– Laboratory Operations And System Validation Lead

Associate Director, Molecular Lab

The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) Vaccines bioanalytical group located at our company new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. A combination of molecular (e.g., PCR), serology (e.g., ligand binding titer immunoassays), and cell-based assays (e.g., neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our company Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

We are seeking a talented, organized, and innovative leader to lead our Laboratory Operations and System Validation team. The successful candidate will coach and mentor staff, oversee the end-to-end lifecycle of regulated laboratory equipment (from onboarding and maintenance to retirement), and manage and improve the computer system validation of laboratory equipment. This individual should be collaborative and capable of developing a network of vendors, QA, IT, and other collaborators to support equipment within an expanding laboratory, balancing ongoing pipeline support while innovating processes.

Position Location: West Point, Pennsylvania (with 25% travel to Spring House, PA)

Responsibilities:

• Lead a team of staff that span across Laboratory Operations and provide supervision, mentorship, and coaching.
• Work closely with divisional/enterprise IT teams, global infrastructure, and risk/security organizations to ensure that project deliverables and ongoing operations receive appropriate support.
• Support the successful implementation of automation solutions, including both platform technologies and associated reporting needs.
• Assist in developing a suite of reporting, analytics, and visualization solutions that support local operations and administrative business processes.
• Ensure automation systems are maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with current GXP requirements.
• Use technical knowledge to assure the efficient operation of a variety of automated processing and operational and informational technology systems.
• Apply deep expertise in the computer system validation process of lab equipment, including the conduct of system validation for diverse lab equipment (e.g., plate readers, lab automation, liquid handlers).
• Oversee asset management activities across a variety of vendors, service engineers, and facilities staff while building and maintaining strong working relationships.
• Serve as a system administrator of equipment applications, temperature monitoring systems, and assist in managing controlled temperature units and alarm handling.
• Partner with vendors, QA, and IT to develop best practices for maintenance requirements and computer system validation processes. Maintain a motivated mindset toward continuous improvement.
• Utilize electronic application platforms (Electronic Notebooks, Procal, Benchling, etc.) to input and retain calibration documentation; participate in efforts to upgrade or replace related applications.
• Represent the DPTM Laboratory Operations on all aspects of laboratory equipment and system validation during audits.
• Operate within the confines of departmental Standard Operating Procedures (SOP) and regulatory guidance; responsible for authorship of equipment-related SOPs and job aids.

Education Minimum Requirement:

• B.S. Degree in Biology, Chemistry, Engineering, or related sciences with at least 8 years of industry experience

Required Experience and Skills:

• Demonstrates strong interpersonal skills with the ability to influence and support others through a culture of inclusion, feedback, and empowerment.
• Strong project management skills, with the ability to plan, execute, and monitor projects to successful completion.
• Follows Standard Operating Procedures with insight for continuous improvement.
• Direct support of validation activities and all other associated Quality functions
• Understands and applies regulatory/compliance requirements relative to their role.
• Experience working within a GxP laboratory, preferably in an analytical lab.
• Experience with supervision/management of staff in a direct reporting relationship.
• Highly organized, and capable of multitasking to manage a variety of equipment or system-related schedules, documents, and maintenance tasks.
• Applies general knowledge of company business developed through education or experience.
• Excellent written and verbal communication skills, with the ability to articulate complex technical information to non-technical stakeholders.
• Ability to work independently and as part of a multidisciplinary team in a challenging environment.
• An analytical person/troubleshooter, skilled in Root Cause Analysis (RCA)