Sr. Manufacturing Associate (Downstream)

Role Title                     Senior Manufacturing Associate (Downstream)  

Department               Manufacturing

Supervisor                 Director of Manufacturing

FLSA                          Exempt

CORE VALUES 

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

FUNCTION SUMMARY      Senior Manufacturing Associate - Downstream

The Senior Manufacturing Associate is responsible to support and participate in the manufacturing of drug products and intermediates following approved procedures while complying with cGMP and GDP. The Senior Manufacturing Associate is expected to understand site quality system and production processes to support drug manufacturing and perform role responsibilities. The Senior Manufacturing Associate 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.
11. Train manufacturing personnel with similar role responsibilities.

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 minimal supervision or unsupervised. Understanding of Microsoft Office Suite (Word, Excel, Teams) and 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.

The Senior Manufacturing Associate must develop the skills necessary to perform required responsibilities to achieve company objectives and goals. The Senior Manufacturing Associate must have strong record keeping, organizational, written, and verbal communication skills to collaborate with manufacturing personnel, interdepartmentally, and act as a lead for other manufacturing personnel. The Senior Manufacturing Associate candidate is desired to have previous experience utilizing good manufacturing or documentation practice.

Education & Experience

• At a minimum B.A./B.S., or M.S. in a science or engineering field with a minimum of 5 years of relevant work experience, or a combination of education and experience.