Associate Specialist, Engineering (Onsite)

MSD • Upper Gwynedd Township, PA

1d • Onsite

About The Position

Seeking candidates for a unique and exciting opportunity to bridge across two pilot scale facilities in Vaccines and Advanced Biotechnologies Process Research & Development (VAXPR&D) and Biologics Process Research and Development. The VAX 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 Associate 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, executing operations on either upstream or downstream steps, and contributing to manufacturing activities in the other discipline as needed. Assignments include all aspects of preparation, execution, and closeout of clinical GMP campaigns. 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.

Requirements

• Bachelor’s degree in Chemical Engineering, Biomedical Engineering or Biological Sciences
• Teamwork and collaboration
• Able to prioritize work with organizational skills
• Principled verbal and written clarifications

Nice To Haves

• Proficient in SAP
• Processing of biologics or vaccines and/or process development activities
• Knowledge of current GMP regulations
• 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.
• Executing downstream operations such as normal flow filtration, chromatography, tangential flow filtration, and centrifugation.
• Preparing critical documents including standard operating procedures, batch records.
• Operating equipment including cleaning & steam sanitization
• Participating in equipment start-up activities.
• Maintaining training compliance on GMP and safety initiatives
• Actively working in a multi-disciplinary project team environment.
• The candidate is expected to work in a team atmosphere in close partnership with tech transfer/development groups, facility engineering, quality engineering, GMP compliance and safety groups.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees