Senior Scientist - GMP Clinical Manufacturing Associate - FSP

Parexel

33d•Onsite

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking to fill a Senior Scientist - GMP Clinical Manufacturing Associate position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This role does not offer sponsorship. About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us!

Requirements

B.S./M.S. in Chemical Engineering or Biological Sciences and relevant years of experience as listed below
Senior Scientist I - B.S. with 5+ years of experience; M.S. with 2+ years
Experience in upstream (cell expansion, bioreactors) and/or downstream processing (depth filtration, chromatography, normal filtration, Tangential flow filtration at pilot scale (50L+)
Software proficiency (Microsoft Word, Excel, PowerPoint)
GMP lab/manufacturing or pilot plant experience
Technical writing (SOPs, reports, etc.)
Mechanical/troubleshooting skills
Ability to work in a team, collaboration

Responsibilities

Executing upstream unit operations such as mammalian/yeast/bacterial cell expansion, virus/protein expression in single-use disposable systems and/or stainless-steel bioreactors.
Performing downstream operations such as normal flow filtration, tangential flow filtration, homogenization, lyophilization, chromatography, and centrifugation.
Preparing critical documents including standard operating procedures, batch records.
Completing production readiness activities such as equipment cleaning & steam sanitization.
Evaluating and integrating innovative technology/process equipment fit.
Developing equipment specifications & participating in start-up activities.
Working in a multi-disciplinary project team environment.
Troubleshooting process unit operations.
Leading process unit operation teams. This person will lead manufacturing steps and must be able to plan, communicate, and lead small groups to achieve tactical objectives.