Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a global pharmaceutical manufacturing company in Raritan, NJ. Please note you will onsite Tuesday thru Sat with Sun/Mon as the weekend.
Title: Scientist II Clinical Research
Location: Raritan, NJ
Duration: 12 months, with likely extension
w2 Hourly Rate: up to $45.00 hour
Prefer Local Candidates
Description:
The Company’s MSAT department is hiring a PhD/MS/BS Scientist in its Emerging Technology department for a Scientist position, to be located in Raritan NJ, USA. The Emerging Technology group optimizes end-to-end manufacturing and analytical processes for the Parenterals Platform via Identification, Integration, and standardization of innovative technologies to address important unmet medical needs in oncology, immunology, neuroscience, cardiovascular, and metabolic diseases. Emerging Technology group also focuses on the development and enhancement of process capabilities across the enterprise.
Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal-opportunity employer.
The successful candidate will work in the mPAD Lab of the Emerging Technology group. The incumbent will be responsible for conducting laboratory experiments designed to evaluate the technical feasibility/readiness level of a variety of new technologies for rapid "Bioburden" or "Microbial Limits" tests relevant to (bio)pharmaceutical manufacturing. Data will be summarized as part of notebook protocols in several different data systems. Report writing and project presentations in internal meetings are also in scope.
In this role, the Scientist will:
• Conduct laboratory experiments from notebook protocols under guidance
o Perform Proof of Principal Studies examining new PAT equipment for rapid microbial testing
• Prepare defined Sample solutions at different concentrations
• Work with BSL2 materials for spiking of bioburden test samples
• Culture of microorganisms
• Set up and tear down of relevant reduced scale operations for additional testing of online, inline, or at-line testing of the PAT tool
• PAT tool set up
• Set up new PAT tools and ensure equipment is in working order
• Assist with IOQ/PQ of PAT tool
• Summarize data in an electronic notebook
Qualifications
• MS / BS in Biology/Microbiology, Pharmaceutical Engineering or Biotechnology, or a related Scientific discipline with at least 2 years of relevant experience is required.
• Experience in microbiological techniques is a must
• Experience with large molecule drug substance & drug product manufacturing processes is a plus
• Knowledge and experience in data analyses and report writing
• Experience with GMP processes is preferred
• Excellent communication skills, both oral and written
• Team player: working in cross-functional teams
Work Schedule:
Work schedule to be Tuesday thru Sat with Sun/Mon as the weekend.
