Role Title Manufacturing Associate I & II
Supervisor Senior Director of Manufacturing
Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration
FUNCTION SUMMARY Manufacturing Associate I & II
The Manufacturing Associate I & II is responsible to support and participate in the manufacturing of drug products and intermediates following approved procedures while complying with cGMP and GDP. The Manufacturing Associate is expected to complete quality system and production training to support drug manufacturing and perform role responsibilities. The Manufacturing Associate is expected to don coveralls and qualify for aseptic gowning, to enter and work in a cleanroom environment.
Duties & Responsibilities:
- Support and participate in the manufacturing of drug product and intermediates, with an emphasis on Downstream manufacturing processes
- Comply with cGMP and GDP regulations
- Clean, operate, and store various processing equipment
- Collect and submit cleaning or in-process samples to Quality Control
- Clean and sterilize manufacturing parts
- Order and dispense raw materials
- Participate in the execution of process development or validation protocols as needed
- Perform inventory cycle counts and site fit-for-use inspections
- Perform revision and creation of SOP’s batch records, or associated protocols under a change control program.
- Perform deviation initiation, investigation, resolution, and CAPA
Education & Experience
- At a minimum, an Associate Degree or B.A./B.S. in a science or engineering field with a minimum of 1 year of relevant work experience (minimum of 2 years for a Manufacturing Associate II), or a combination of education and experience.
The Manufacturing Associate I must develop the skills necessary to perform required responsibilities to achieve company objectives and goals. This person must have strong record keeping, organizational, written, and verbal communication skills to collaborative with manufacturing personnel & interdepartmentally. This candidate is desired to have previous experience utilizing good manufacturing or documentation practice.
Skills & Competencies
- Performs tasks while maintaining cGMP compliance. For Manufacturing Associate II, experience with either upstream or downstream biologic manufacturing. Ability to perform responsibilities under direct or minimal supervision. Understanding of Microsoft Office Suite and/or other organizational applications. Good written, verbal, and communication skills. Ability to communicate interdepartmentally with Quality Control, Facilities, MSATs and Quality Assurance for manufacturing related projects.