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.

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.

** Responsibilities*
* Technical 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,…