Technical Lead - Pharmaceutical Manufacturing Analytics

Battelle delivers when others can’t. We conduct research and development, manage national laboratories, design and manufacture products and deliver critical services for our clients—whether they are a multi‑national corporation, a small start‑up or a government agency. We recognize and appreciate the value and contributions of individuals from a wide range of backgrounds and experiences and welcome all qualified individuals to apply. Job Summary 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. Key Qualifications 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. Preferred Qualifications 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 Act as technical leadership by providing subject‑matter expertise in pharmaceutical or biopharmaceutical manufacturing processes. Contribute to the 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 Balance life through a compressed work schedule: Most of our team follows a flexible, compressed work schedule that allows for every other Friday off—giving you a dedicated day to accomplish things in your personal life without using vacation time. Enjoy enhanced work flexibility, including a hybrid arrangement: You have options for where and when you work. Our Together with Flexibility model allows you to work 60% in‑office and 40% remote, with Monday and Tuesday as common in‑office days, dependent on team and position needs. Take time to recharge: You get paid time off to support work‑life balance and keep motivated. Prioritize wellness: Stay healthy with medical, dental, and vision coverage with wellness incentives and benefits plus a variety of optional supplemental benefits. Better together: Coverage for partners, gender‑affirming care and health support, and family formation support. Build your financial future: Build financial stability with an industry‑leading 401(k) retirement savings plan. For most employees, we put in 5 percent whether you contribute or not, and match your contributions on top of that. Advance your education: Tuition assistance is available to pursue higher education. A Work Environment Where You Succeed Apply your talent to challenging and meaningful projects. Receive select funding to pursue ideas in scientific and technological discovery. Partner with world‑class experts in a collaborative environment. Nurture and develop the next generation of scientific leaders. Give back to and improve our communities. Vaccinations & Safety Protocols Battelle may require employees, based on job duties, work location, and/or its clients’ requirements to follow certain safety protocols and to be vaccinated against a variety of viruses, bacteria, and diseases as a condition of employment and continued employment and to provide documentation that they are fully vaccinated. If applicable, Battelle will provide reasonable accommodations based on a qualified disability or medical condition through the Americans with Disabilities Act or the Rehabilitation Act or for a sincerely held religious belief under Title VII of the Civil Rights Act of 1964 (and related state laws). Battelle is an equal opportunity employer. We provide employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex (including pregnancy), national origin, sexual orientation, gender identity or expression, marital status, age, genetic information, disability, veteran‑status veteran or military status, or any other characteristic protected under applicable Federal, state, or local law. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. We will support positive programs for equal treatment of all staff and full utilization of all qualified employees at all levels within Battelle. The above statements are intended to describe the nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, activities and skills required of staff members. No statement herein is intended to imply any authorities to commit Battelle unless special written permission is granted by Battelle's Legal Department. #J-18808-Ljbffr Battelle