Specialist, Engineering (Onsite)

Job Description

In our Company's Research Labs, we identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough.

Seeking candidates for a unique and exciting opportunity to bridge across two pilot scale facilities in VAX and Biologics Process Research and Development. The Vaccines and Advanced Biotechnologies Process Research & Development (VAXPR&D) and Biologics Process Research & Development organizations within our Company Research Labs are broadly responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products

This Specialist role will first support the Biologics Pilot Plant (BPP) Operations Team. This person will work on pilot-scale campaigns for the Good Manufacturing Practice (GMP) manufacture of bulk clinical supplies, leading operations on either upstream or downstream steps, and contributing to manufacturing activities in the other discipline as needed. Strong comprehension of regulatory guidelines governing GMP manufacture is essential. The candidate will work in matrixed teams with analytical and tech transfer/process development, facility engineering, quality engineering, GMP compliance, and safety groups. Some overtime, including weekends and occasional second and third shift work, will be required. Assignments include all aspects of preparation, execution, and closeout of a GMP campaign.

The position will be temporarily based in West Point, PA for approximately 18 months (up to 24 months) to support business needs. After this period, the role is intended to relocate to Rahway, NJ. Applicants should be comfortable with this planned geographic transition. In Rahway, the position will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms.

Primary 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, 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 teams. This person will lead manufacturing steps and must be able to plan, communicate, and lead small groups to achieve tactical objectives.
 

Education Minimum Requirements:

·         Bachelor’s degree in Chemical Engineering or Biological Sciences with 2 full years of relevant experience or a Master’s degree with 1+ years of relevant experience.

Required Experience and Skills:

·         GMP manufacturing of biologics, or vaccines, and/or pro