Category: Scientific & Clinical
Job Title: Manufacturing Associate
Location: Beltsville, MD
Schedule: Monday-Friday Day Shift
Start Date: Immediate
Great opportunity with a Biopharmaceutical Company located in Maryland that focuses on the discovery and development of novel therapeutic biologics for the treatment of cancer and other immune-related diseases.
- Research into new technologies and procedures for the purposes of technical transfer and/or process improvements.
- Ensure the successful time-sensitive GMP manufacture and release of products with minimal to zero deviations
- Responsibilities include supporting investigations, and working with other departments to drive continuous improvements.
- Responsible for planning ahead to avoid delays, good documentation practices, and providing leadership for the manufacturing team.
- Identifies, plans and implements innovative technological programs and solutions
- Acts as a qualified trainer and is the subject matter expert for biopharmaceutical manufacturing equipment
- Interfaces with Manufacturing Development and Process Development for tech transfer activities and process design.
- Writes, revises and executes all types of controlled documentation (SOP’s, Production Batch Records, Technical Reports, Protocols, etc.).
- Interfaces with validation, engineering and facilities personnel in start-up, testing and operation of manufacturing equipment.
- Develops project plans including work scope, timeline and cost estimates for process improvements
- Interfaces, schedules and performs on-site monitoring of outside services of all manufacturing equipment.
- Establish tracking and trending analyses of process development, pilot and cGMP production runs
- Bachelor’s degree in Engineering (biochemical, chemical, mechanical), biology, or chemistry
- 6 months-5 years of GMP manufacturing experience and downstream tech transfer or process development experience
- Knowledgeable of application and practices of current GMP’s, international regulatory requirements and guidelines
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.