Director, Regulated Bioanalytics Molecular Late-Stage Vaccine Clinical Development

Job Description

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a director to lead the Molecular Lab within the Late Development (AdVAnce) Vaccines bioanalytical group located at our Company's 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's Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

The successful Molecular Director candidate will drive the science and operations within the Molecular Lab team.  As the facility and teams are all new, the Molecular Director will first recruit and assemble the Molecular team and validate assays on new end-to-end integrated robotics platforms.  As a member of the Late Development Vaccines bioanalytical leadership team, they will partner with other leaders to create site processes.  Leadership responsibilities will include coaching and mentorship of all Molecular team scientists, guiding and improving efficient phase III testing, troubleshooting assay challenges, and supporting any related regulatory questions or inspections of the Molecular lab or data.   The Molecular Director will also be responsible for developing business plans for the Molecular Lab team, including financial, operational, and organizational priorities.

Responsibilities:

• Provides leadership to managers and individual contributors on Molecular Lab team

• Leverages deep scientific expertise with clinical bioanalytical molecular assays, such as PCR based serotyping, to optimize and validate methods using integrated robotic platforms

• Oversees phase III molecular assay testing across several studies and/or vaccine candidates and reviews and approves data as needed

• Resolves complex technical, operational, and financial problems

• Applies business and management expertise to set and achieve financial and operational objectives for the Molecular Lab

• Influences others internally and externally, including senior leaders, internal customers, and external partners

• Develops relationships with key stakeholders, including robotics, IT, quality, and other partnering organizations to drive improved, quality operations

• Contributes to the development of departmental strategy and represents department on leadership and development teams

• Develops priorities and objectives for the Molecular Lab and AdVAnce team to align with division scorecard

• Represents the Molecular Lab for internal and external audits

• Promotes our company’s scientific excellence and regulatory influence through leadership in the scientific community

Education Minimum Requirement:

• B.A./B.S. in Molecular Biology, Immunology, Cell Biology, Biology, or Biochemistry or a related Biological Sciences discipline with at least 15 years, M.S. with at least 10 years, or Ph.D. with at least 8 years of related experience

Required Experience & Skills:

• Expertise in various assays formats, including but not limited to molecular assays such as PCR

• Ability to lead, mentor, and inspire scientists at various levels; encourages curiosity in others and challenges the status quo to foster innovation

• Demonstrated ability for taking initiative, creativity, and innovation in problem solving

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment

• Experience in Agency inspections/audits  

• Experience with regulatory submissions

• Experience working within a GLP, GMP, or other GxP laboratory

• Preferred Experience & Skills

• Project management skills

• Established scientific reputation supported by publications and/or external presentations

• Experience working in a GLP bioanalytical laboratory 

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