Role Summary
Senior Director of Technical Services/Manufacturing Science (TS/MS) leading the Clinton siteโs large-scale commercial manufacturing technical stewardship. Drive process reliability, enable continuous improvement, and ensure seamless technology transfer for new and existing products. Serve as a key member of the Site Leadership Team and Global TS/MS network, influencing site strategy, quality performance, and scientific excellence.
Responsibilities
- Provide strategic and hands-on technical oversight of fermentation, premix, liquid formulation, and packaging operations, ensuring robust process stewardship, data-driven decision-making, and reliable large-scale commercial performance
- Champion continuous process optimization through advanced process monitoring, rigorous scientific approaches, and strong process metrics to improve yield, reduce variability, drive cost efficiencies, and strengthen operational excellence
- Build and develop a high-performing TS/MS technical organization through targeted onboarding, technical capability development, role-specific training, staff qualification, and leadership coaching to support long-term site capabilities
- Maintain validated and compliant processes, systems, and equipment by ensuring deep process understanding, clear control strategies, accurate specifications, robust validation practices, and alignment with global regulatory and cGMP expectations
- Serve as a key site and global TS/MS leader โ partnering with R&D for seamless tech transfers, guiding regulatory and quality audit responses, contributing to site GMP and business plans, and influencing network-wide scientific and operational strategy
Qualifications
- Required: Bachelorโs degree in Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, or Bio/Chemical Engineering; or combination of education and relevant work experience
- Required: A minimum of 10 years of relevant technical experience in GMP manufacturing, process development, or technical services, including 5+ years of people leadership
- Required: Advanced technical & process leadership + strong people leadership and strategic decision-making in a GMP manufacturing environment
- Preferred: Experience in pharmaceutical or bioprocess manufacturing, technical service, or process development environments
- Preferred: Background in Quality, Engineering, Regulatory, or advanced project management in a regulated environment
- Preferred: Hands-on experience with fermentation, biologics, formulation, packaging, or tech transfer
- Preferred: Demonstrated success building technical organizations and mentoring high-performing scientific talent
- Preferred: Experience leading through inspections or regulatory agency interactions
Additional Requirements
- Location: Clinton, IN โ Onsite Leadership
- Other: Entry into manufacturing areas may require PPE; completion of TS/MS ITP program required