Biopharmaceutical Manufacturing Associate I - Fermenation
Apex Systems has a fantastic contract opportunity for an entry-level Bio Analytical Manufacturing Associate to work at a leading Bio-Pharmaceutical company in the Montgomery County area. The ideal candidate will have 0-3 years’ of experience in a GMP Manufacturing environment. Ideal candidate will have a BS in Biochemistry, Biology, Chemistry or BioEngineering.
The Manufacturing Associate I, Fermentation works in a hands-on capacity in the cGMP fermentation and production support areas to manufacture collagenase clostridium histolyticum (CCH) bulk drug substance (BDS). This role is responsible for supporting necessary fermentation and production activities, including validation and development work as needed.
- Performs daily fermentation steps of cGMP manufacture of CCH BDS.
- Works in a hands-on capacity to operate fermenters, perform seed scale-up, sterilize equipment, prepare media solutions, and clean equipment as required.
- Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.a
- Assists with process, equipment, and cleaning validation initiatives.
- Assists in the resolution of manufacturing deviations/non-conformances.
- Under direct supervision, assists with troubleshooting processes and equipment.
- HS Degree is required.
- Minimum 0 to 3 years working in biopharmaceutical cGMP manufacturing environment, or equivalence in relevant experience.
Knowledge, Skills and Abilities:
- General knowledge of cGMP practices, ICH guidelines, and validation practices.
- General knowledge of cleaning and sterilization procedures for biopharmaceutical products.
- 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.
Please send resumes to Email blocked - click to apply for Immediate Consideration.
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