Senior Scientist, Antibody Developability and Characterization - Military Veterans

Job Description

Description -
The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a Senior Director to lead the Regulated Robotics & LIMS team within the Exploratory Vaccines & Regulated Robotics group. This role will support work across groups within the Regulated Bioanalytics Department, 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 strategic and scientific direction and drive operations within the Regulated Robotics & LIMS team. The Senior Director will be accountable for the Regulated Robotics Engineering, Liquid Handlers, and LIMS & Data Management teams' delivery. This team will develop and implement automation workflows and tools to increase the efficiency of processes, data review, and data visualization in support of our Vaccines pipeline. The desired candidate must also show strong working knowledge of implementing regulated (preclinical and clinical) assays and have experience in supporting regulatory submissions and responses. The incumbent will be responsible for the recruiting and development of talent under her/his supervision.

Responsibilities

• Provides leadership to managers of the Regulated Robotics & LIMS team (overseeing Regulated Robotics Engineering, Liquid Handlers, LIMS & Data Management)
• Leads and mentors engineers and scientists up to PhD level by providing direction, scientific feedback, and ideas
• Communicates results effectively in presentations to stakeholders in partner organizations or at external scientific meetings
• Identifies opportunities for new collaborations, engages collaborators, identifies business needs and values, and proposes proper solutions
• Leverages deep expertise in robotic automation and IT innovative solutions to influence general and program-specific assay development, implement robotic solutions, deploy updated or new LIMS systems, and develop visualization tools for the review of experimental data and for IT tools used to track material through automated systems
• Serves as a Regulated Robotics representative on development teams that collaborates with various vaccine development program leaders across our Company
• Resolves complex technical, operational, and financial problems
• Applies business and management expertise to set and achieve financial and operational objectives for the Regulated Robotics team
• Drives the computer system validation efforts for all departmental automation systems and LIMS.
• 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
• Promotes our company's scientific excellence and regulatory influence through leadership in the scientific community

Education Minimum Requirement

• B.A./B.S. in Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences or a related discipline with at least 16 years, M.S. with at least 15 years, or Ph.D. with at least 12 years of related experience

Required Experience & Skills

• Strong scientific and technical expertise in regulated assay design, automation, development, LIMS systems, system validation, and execution of these in support of GLP and clinical development programs
• Deep understanding of statistical methods to analyze and visualize large data sets
• Significant experience in algorithm development and implementation
• Significant experience with software visualization programs
• 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 as well as data analysis and statistics for reporting clinical data
• Ability to lead, mentor, and inspire scientists at various levels; encourages curiosity in others and challenges the status quo to foster innovation
• 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
• 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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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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Employee Status:
Regular

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Flexible Work Arrangements:
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Job Posting End Date:
12/26/2024
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