Technical Lead - Pharmaceutical Manufacturing Analytics

Battelle • Columbus, OH

10d • Hybrid

About The Position

Battelle is seeking a Technical Lead to support development and integration of the analytical and computational components of Quality by Design (QbD) through AI-enabled analytics for advanced and agile pharmaceutical manufacturing aligned with federal health and national security missions. This role combines pharmaceutical manufacturing QbD expertise with analytical and modeling capabilities to help develop tools such as digital twins, PAT-based predictive models to support real-time release testing (RTRT), AI-driven process control strategies, and manufacturing resilience models. The position focuses on enabling government partners to analyze, evaluate, and optimize pharmaceutical manufacturing platforms, rather than operating manufacturing facilities. The Technical Lead will work with interdisciplinary teams across analytical and synthetic chemistry, chemical engineering, synthetic biology, bioprocess engineering, data science, IT systems management, and systems engineering to support research programs, develop technical prototypes, and contribute to proposal development for federal clients such as ASPR/IBMSC, BARDA, ARPA H, FDA, and the Department of Defense.

Requirements

• Advanced degree (PhD or MS with significant experience) in analytical chemistry, chemical engineering, pharmaceutical engineering or sciences, biochemistry, or a related field
• 5–10 years of experience in pharmaceutical or biopharmaceutical manufacturing, process development, or manufacturing technology
• Experience with advanced usage of PAT in pharmaceutical manufacturing processes to support RTRT such as: Process monitoring and real-time analytical methods, Chemometrics, multivariate data analysis, AI/ML for process monitoring, Spectroscopic (NIR, mid-IR, Raman, fluorescence) and chromatographic methods (MPLC, GC, LC-MS)
• Regulatory compliance, validation, and development of analytical methods under cGMP / GLP standards
• Experience working in interdisciplinary technical teams
• Strong understanding of pharmaceutical manufacturing processes
• Ability to collaborate with data scientists and modeling experts
• Applied problem-solving in manufacturing or process development environments
• Clear technical communication and documentation skills
• Interest in applying advanced analytics to manufacturing systems

Nice To Haves

• Familiarity with continuous pharmaceutical manufacturing or advanced manufacturing technologies
• Experience with modeling, simulation, or data analytics applied to manufacturing processes
• Knowledge of FDA regulatory expectations related to pharmaceutical manufacturing
• Experience supporting federally funded research or collaborative R&D programs
• Experience in supply chain and manufacturing network simulations

Responsibilities

• Provide subject-matter expertise in pharmaceutical or biopharmaceutical manufacturing processes
• Contribute to development of analytical tools such as: Manufacturing digital twins, AI-enabled process analytics, PAT-based quality prediction models, Process control strategy implementation
• Ensure technical models and analytics reflect realistic pharmaceutical manufacturing processes
• Lead technical tasks within R&D projects related to advanced pharmaceutical manufacturing analytics
• Work closely with cross-disciplinary teams to develop and test analytical tools
• Support development of prototypes, demonstrations, and technical reports
• Contribute to internal R&D efforts exploring AI-enabled manufacturing approaches
• Identify opportunities to apply emerging analytics approaches to pharmaceutical manufacturing challenges
• Participate in technical publications, presentations, and white papers
• Support development of proposals for federal R&D programs related to pharmaceutical manufacturing innovation
• Provide technical input on project concepts, methodologies, and feasibility
• Collaborate with academic partners, manufacturing institutes, and technology developers
• Support technology transfer of analytical and modeling capabilities to industry partners
• Participate in relevant conferences, workshops, and technical forums
• Support engagement with federal agencies and program stakeholders

Benefits

• Compressed work schedule (every other Friday off)
• Hybrid work arrangement (60% in-office, 40% remote)
• Paid time off
• Medical, dental, and vision coverage
• Wellness incentives and benefits
• Supplemental benefits
• Coverage for partners, gender-affirming care and health support, and family formation support
• 401(k) retirement savings plan with employer contribution
• Tuition assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior