Job Details
This global CDMO is at the forefront of pharmaceutical and biotech development. They focus on turning scientific discoveries into real-world solutions that improve health outcomes. The team environment encourages learning and growth, with plenty of opportunities to work on diverse, international projects with household names in healthcare and healthcare technology.
The firm is looking to appoint an MSAT Scientist Process Engineer to support their downstream manufacturing process, with the position being on-site at their location on the coast of New Hampshire.
They value their employees highly, providing a supportive workplace that prioritizes professional development and well-being. By joining, you'd be part of a dedicated team that's making a meaningful difference in healthcare, backed by a commitment to diversity and inclusion.
Your Role as Downstream MSAT Scientist Process Engineer:
- Function as the internal expert for sophisticated downstream production processes.
- Liaise across project teams, coordinating closely with client technical and quality advisors.
- Drive advancements in process comprehension and control, contributing to the team's knowledge base.
- Take responsibility for crafting and revising critical process documentation, such as process guides and batch records.
- Manage and execute change controls, overseeing modifications from conception through to completion.
- Analyze and present manufacturing data to support process optimization and report performance metrics effectively.
Experience and Qualifications for the Downstream MSAT Scientist Process Engineer Role
Qualified applicants will demonstrate:
- A Bachelor's degree or higher in Biotechnology, Biological Sciences, or Chemical Engineering.
- Robust experience in biotechnology, specifically in process development, scale-up, technology transfer, or direct manufacturing, with expertise in large-scale (2 kL+) mammalian systems being advantageous.
- Comprehensive knowledge of cGMP standards along with regulatory guidelines in the U.S. and Europe.
- Strong foundational knowledge in cell biology, protein chemistry, chromatographic techniques, ultrafiltration/defiltration, virus filtration, and basic statistical analysis.
- Excellent communication skills, with a proven ability to convey complex ideas effectively and foster strong relationships.
- A dedication to maintaining safety standards and assessing the impact of actions in a regulated environment.
- Willingness to participate in a 24/7 on-call rotation during active manufacturing phases.
Applicants should be based in or willing to relocate to the Portsmouth, NH area, as regular on-site involvement is a requirement. On this occasion we are unable to consider applicants who do not have the right to work in the US.
Apply today for immediate consideration. For those interested in exploring similar opportunities in this sector, please reach out to discuss further.