Horsham, PA, USA
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.
Scope of Authority – Purification and related manufacturing operations for the Horsham, PA site.
Manufacturing & Compliance = 95%
- Performs daily purification steps for cGMP manufacture of CCH BDS.
- Works in a hands-on capacity to operate chromatography systems, ÄKTA chromatography controllers, UF/DF skids, perform sterile filtrations, prepare production buffers, and clean equipment.
- 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.
Investigation = 5%
- Assists in the resolution of manufacturing deviations/non-conformances.
- Under direct supervision, assists with troubleshooting processes and equipment.
Education & Experience
- High school diploma is required with a minimum of 0-3 years working in a pharmaceutical/biopharmaceutical cGMP manufacturing environment.
- 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.
- 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.
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