The purpose of this position is to perform tasks and operations relevant to the bulk formulation and/or filling operations required for sterile production of liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing.
General 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
Qualifications
- 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