Manufacturing Associate II (Downstream)

Role Title                         Manufacturing Associate II - Downstream

Department                     Manufacturing  

Supervisor                      Director of Manufacturing

FLSA                               Exempt

CORE VALUES 

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

FUNCTION SUMMARY      Manufacturing Associate II - Downstream

The Manufacturing Associate II (Downstream) 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 II is expected to complete quality system and production training to support drug manufacturing and perform role responsibilities. The Manufacturing Associate II is expected to don coveralls and qualify for aseptic gowning, to enter and work in a cleanroom environment.

Duties & Responsibilities:

1. Support and participate in the manufacturing of drug product and intermediates, with an emphasis on Downstream manufacturing processes
2. Comply with cGMP and GDP regulations
3. Clean, operate, and store various processing equipment
4. Collect and submit cleaning or in-process samples to Quality Control
5. Clean and sterilize manufacturing parts
6. Order and dispense raw materials
7. Participate in the execution of process development or validation protocols as needed
8. Perform inventory cycle counts and site fit-for-use inspections
9. Perform revision and creation of SOP’s batch records, or associated protocols under a change control program.
10. 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 2 years of relevant work experience, or a combination of education and experience.

The Manufacturing Associate II 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.
• Experience with large-scale Downstream manufacturing processes, including: column chromatography, UF/DF, sterile filtration, and buffer preparation.
• 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.