This is a temporary-to-hire, on-site position supporting bulk formulation and/or filling operations for sterile liquid injectable pharmaceutical products under cGMP regulations. The role is Monday-Friday, 8 hours/day (excluding lunch) with a flexible start between 7:00-9:00 am. Overtime, weekends, and holidays may be required.
Duties and Responsibilities
Perform various routine manufacturing tasks under the direction of internal SOP's and cGMP guidelines
Prepare material components for manufacturing operations
Document steps clearly and completely in production batch records, logbooks and other controlled forms
Participate in inspection readiness activities
Perform basic arithmetic and algebraic computation
Maintain cleanliness of areas and equipment
Assist senior level personnel in bulk drug formulation using a variety of lab equipment including mixers, balances, pH meters, etc., gowned in accordance with Class C (ISO 7) conditions
Assist senior level personnel in sterile filtration activities, gowned in accordance with Class C (ISO 7) conditions
Assist senior level personnel in sterile filling of a multitude of solutions including drug product, media, buffers, using an automated filling and closing machine, gowned in accordance with Class C (ISO 7) conditions
Collect and dispose of lab wastes according to established procedures
Collaborate in continuous improvement activities
- This position may require local travel between company facilities within a short distance (approximately 3 miles) based on business needs.
Education and Experience Requirements
High school diploma or equivalent with 1 - 2 years relevant experience is required, a Bachelor's in an Engineering discipline or Life Science field preferred
Time and project management skills with the ability to multi-task are essential
Must be able to effectively communicate within department and cross-functionally with other divisions
High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business, is a plus