Specialist, Engineering

Merck•Upper Gwynedd Township, PA

3d•Onsite

About The Position

Our Research Scientists are our Inventors. 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 Specialist position within our company's research laboratories 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 unit operations on either upstream or downstream steps, and contributing to manufacturing activities in the other discipline as needed. Working comprehension of regulatory guidelines governing GMP manufacture is essential. The candidate will work in matrixed teams with 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.

Requirements

GMP manufacturing of biologics, or vaccines, and/or process development activities.
Teamwork and collaboration
Working knowledge of cGMP, Quality Systems, and safety for operations
Self-motivated with the ability to work in a fast-paced and dynamic setting

Nice To Haves

Organizational, problem-solving, and project management skills
Technical background in one or more process unit operations
Experience leading small teams in a matrixed organization
Demonstration of Decision Making, Execution Excellence, and Ownership and Accountability Leadership Skills

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.