Manufacturing Associate I, Downstream Processing

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

The Manufacturing Associate I, Downstream Processing works in a hands-on capacity in the cGMP purification and production support areas to manufacture collagenase clostridium histolyticum bulk drug substance (CCH BDS). This role is responsible for supporting necessary purification and production activities, including validation and development work as needed.

Responsibilities

Manufacturing & Compliance
Performs daily purification steps for cGMP manufacture of CCH BDS.
Works in a hands-on capacity to operate chromatography systems, AKTA chromatography controllers, UF/DF skids, perform sterile filtrations, prepare production buffers, and clean equipment.
Responsible for clean room readiness, stocking, and transfer of materials into the Manufacturing Facility.
Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
Assists with process, equipment, and cleaning validation initiatives.
Documentation
Assists with GMP document revision.
Investigation
Assists in the resolution of manufacturing deviations/non-conformances.
Under direct supervision, assists with troubleshooting processes and equipment.

Qualifications

Education & Experience
High school diploma is required with a minimum of 0-1 years working in a pharmaceutical/biopharmaceutical cGMP manufacturing environment OR
BS degree

Knowledge
General knowledge of cGMP practices, ICH guideline, and validation practices.
General knowledge of equipment cleaning practices and purification methods for biopharmaceutical products.

Skills & Abilities
Ability to work well with others and establish working relationships with Quality, Facilities/Engineering/Validation, Process Validation/Development, and Manufacturing.
Exhibits attention to detail, accuracy in work, and integrity of character.
Self-starter, shows willingness to learn and problem-solve.
Has technical aptitude to learn and operate production equipment.

Physical Requirements
Standing for long periods of time.
Ability to wear a sterile gown and don shoe covers on a daily basis.
Ability to lift 40 pounds.