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.
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