Director, Regulated Bioanalytics, Exploratory Vaccines Robotics

Job Description

Description

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Department is seeking a Director to lead the Regulated Robotics Engineering team within the Regulated Robotics group.  This role will support work across groups within the Regulated Bioanalytics Department based in Pennsylvania, including work 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.  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 primary role of the successful candidate will be to set the strategic direction and implement end-to-end assay robotics for vaccine program assays.  The position is accountable for delivering automated phase-appropriate, robust analytical clinical methods that adhere to the highest scientific standards on both in-house engineered and commercial-grade robotic systems. The desired candidate must also show strong working knowledge of system validation, and have experience driving system validation projects (i.e. SDLC) that meet data integrity, 21CFR11, change control, and other regulatory requirements.  In this role, responsibilities include coaching and mentoring within and across the organization, developing strong relationships with vendors, internal IT, and Regulated BA staff, and serve as a strong member of the Regulated Robotics and LIMS leadership team. The incumbent will be responsible for the recruiting and development of talent under her/his supervision.

Education Minimum Requirement

• B.A./B.S. in Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences or a related discipline with at least 15 years of relevant experience, an M.S. with at least 10 years, or Ph.D. with at least 8 years of related experience

Responsibilities

• Provides leadership to individual contributors in the Regulated Robotics team

• Leverages deep expertise in implementing and transferring robotic innovative solutions in support of vaccine clinical assay development, qualification, validation, and non-clinical through phase III clinical testing.  

• Provide scientific oversight for robotic platforms  being implemented at CROs, including review of trending data and technical reports. Some travel to CROs required.

• Serve as a program representative on development teams that collaborates with various vaccine development program leaders across our Company

• Resolves complex technical, operational, and financial problems involving laboratory automation

• Reviews and approves data as needed

• Applies business and management expertise to set and achieve financial and operational objectives for the Regulated Robotics team

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

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

• Develops priorities and objectives for the Regulated Robotics group to align with division scorecard

• Leads the computer system validation (i.e. SDLC) efforts for the Regulated Bioanalytics organization for new systems or change controls involving lab automation

• Serves at the Regulated Bioanalytical robotics lead during internal and external regulatory audits

Required Experience & Skills

• Strong scientific and technical expertise in regulated assay design, automation, development, transfer, and execution in support of GLP and clinical development programs

• Proven ability to lead development of new, innovative approaches including experience with new assay technology evaluations and shaping scientific and assay automation strategy both at the platform and program level

• Research and industry experience should demonstrate successful application and management of state-of-the-art automation, including experience with a variety of analytical automation platforms, & sound scientific understanding of QbD/DOE principles 

• Ability to lead, mentor, and inspire laboratory 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 computer system validation

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

• Excellent oral and written communication skills

• Experience leading diverse teams and driving a collaborative and inclusive mindset

Preferred Experience & Skills

• Background in biostatistics, and/or information management systems is desirable

• Working knowledge of AI coding using machine learning algorithms and deep learning neural networks to assist with robotic solutions

• Strong external scientific reputation including publications, regulatory guidance documents, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia 

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