Job SummaryBattelle 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.
A successful candidate will:
- Provide credible pharmaceutical manufacturing expertise within multidisciplinary analytics teams
- Help translate manufacturing challenges into data-driven analytical tools
- Contribute to the growth of Battelle's capabilities in advanced pharmaceutical manufacturing analytics
- Support development of federally funded research and implementation programs in this emerging area.
ResponsibilitiesTechnical Leadership
- 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
Project Execution
- 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
Research and Innovation
- 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
Proposal Development
- Support development of proposals for federal R&D programs related to pharmaceutical manufacturing innovation
- Provide technical input on project concepts, methodologies, and feasibility
Collaboration and External Engagement
- 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
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
Benefits: Live an Extraordinary LifeWe care about your well-being, not just on the job. Battelle offers comprehensive and competitive benefits to help you live your best life.
- 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.
