MS&T ScientistNew

MS&T Scientist (Specialist) - Bioprocess Laboratory

Are you passionate about innovation in biologics manufacturing? We are looking for an MS&T Scientist (Specialist) to join our Manufacturing Science and Technology (MS&T) team at our state-of-the-art, single-use, multi-product facility.

About the Role

As an MS&T Scientist (Specialist), you will contribute to the overall operation of the MS&T Bioprocess Laboratory, working as part of a dynamic and interdisciplinary team. You will play a key role in building capability and knowledge in biologics manufacturing and supporting new product introductions.

Key Responsibilities

Plan and execute analytical testing to support USP-DSP scale-down model establishments, satellite runs, and improvement studies. Design and perform DSP laboratory studies, including chromatography runs and filter assessments. Support the transfer of analytical methods into the MS&T laboratory. Provide specialist analytical support for non-routine analysis and troubleshooting. Conduct experimental design, execution, data analysis, and interpretation. Author and review standard operating procedures (SOPs) and technical reports. Collaborate with multidisciplinary teams (MS&T, quality, analytics, regulatory) for process improvement and troubleshooting. Apply Lean Six Sigma and Change Management principles in the Analytical Sciences group. Lead and coach others in problem-solving and continuous improvement initiatives. Serve as an analytical specialist during internal audits and external inspections. Align and exchange knowledge with development organizations, commercial nodes, and external manufacturing partners. Conduct product robustness monitoring in partnership with global technical teams and lead investigations. Demonstrate a safety-first, quality-always mindset in all responsibilities.

Qualifications & Experience

Bachelor's degree in a relevant scientific discipline with 5+ years of experience, OR Master's degree with 3+ years of experience, OR PhD in biotechnology, biochemistry, pharmacy, process engineering, or equivalent. Technical expertise in biologics drug substance upstream and downstream operations, analytical testing, process development, and tech transfer. Ability to work independently and as part of a team in a fast-paced, innovative environment. Strong problem-solving, troubleshooting, and influencing skills. Excellent communication skills and deep scientific expertise. Experience in a GMP / regulated environment is desirable. Strong organizational skills with the ability to manage multiple priorities and escalate issues as needed.

---