Drug Product Manufacturing Associate

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 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

Questions HM would like to know about each candidate.

Do they carry a degree in any life science or engineering discipline, if so which and what level?

Are they comfortable performing basic algebraic and arithmetic calculations?

Have they worked in aseptic processing, if so, what specifically?

Have they had any experience with Quality Management Systems, if so which?

Have they worked with material resource planning, if so, which and to what extent?

$24 / hr DOE