MS&T Scientist (Specialist)

Job Purpose

This role is part of the Manufacturing Science and Technology (MS&T) hub at a state-of-the-art, single-use, multi-product facility. The MS&T Scientist (Specialist) is responsible for contributing to the overall running of the MS&T Bioprocess Laboratory and working across the site as part of a diverse and interdisciplinary team to build capability and knowledge in the manufacture of biologics at the facility. This includes planning and executing scale-down model establishment, analytical testing, satellite and improvement studies, and providing technical expertise and leadership to support successful new producdut introction.

Responsibilities

• Plan and execute analytical testing to support upstream (USP) and downstream (DSP) scale-down model establishments, satellite runs, and investigation/improvement studies in the MS&T lab.
• Plan and execute DSP laboratory studies (i.e., chromatography runs, filter assessments).
• Support the transfer of analytical methods into the MS&T laboratory.
• Provide specialist analytical support to the site and network for non-routine analysis and troubleshooting.
• Design, execute, analyze, and interpret experimental data.
• Author and review standard operating procedures (SOPs) and technical reports.
• Support multidisciplinary teams (MS&T, quality, analytics, regulatory) for process improvement and troubleshooting.
• Assure effective application of Lean Six Sigma and Change Management tools in the Analytical Sciences group by:
• Securing continuity of an appropriate level of knowledge.
• Facilitating problem-solving & risk assessment (FMEA) projects/meetings.
• Making problems visible and striving for continuous improvement.
• Serve as an analytical specialist during internal audits and external inspections/audits.
• Support alignment and knowledge exchange with development organizations, other commercial nodes, and external manufacturing partners.
• Lead and coach others to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve, and develop.
• Demonstrate excellent troubleshooting, problem-solving, collaboration, and influencing skills to represent MS&T on global and interdisciplinary teams.
• Complete product robustness monitoring in partnership with global technical teams and provide leadership for investigations.
• Demonstrate a “safety first, quality always” mindset in all responsibilities.

Educational & Experience Requirements

• Bachelor’s degree in biotechnology, biochemistry, pharmacy, process engineering, or equivalent with a minimum of 5 years of experience.
• Master’s degree with a minimum of 3 years of experience.
• PhD in a relevant scientific discipline.
• Technical expertise in biologics drug substance upstream and downstream operations, analytical testing, process development, and tech transfer.
• Proven ability to work both independently and collaboratively as part of a team.
• Strong logical thinking and proactive problem-solving skills under pressure.
• Effective communicator with deep technical expertise in science.
• Experience working cross-functionally, tracking schedules, and embracing an interdependent work culture.
• Experience in a GMP/regulatory environment is desirable.
• Strong organizational skills with the ability to manage multiple priorities and escalate issues when necessary.