Description
Position Summary:The incumbent will be a part of the manufacturing organization and provide hands-on execution of tasks related to the GMP manufacture of biopharmaceuticals working primarily in drug product fill/finish. The incumbent will help provide the technical skill-sets necessary to manufacture high quality biological materials safely in a compliant, efficient, and cost effective manner. Operations are predominately conducted under GMP guidelines.Essential Functions:
- Train in fill-finish area of manufacturing and provide support as needed in all areas of manufacturing, including fermentation, purification.
- Become a processing and equipment expert and serve as a hands-on resource in Production.
- Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.) in support of manufacturing intermediate, bulk or final drug product of acceptable quality to meet FDA regulatory quality requirements.
- Assembly, set-up and disassembly of production equipment.
- Interface with process automation systems.
- Authoring and/or modifying production documentation as needed.
- Conduct all assigned activities in a safe and cGMP compliant manner.
- Ensure compliance with established internal control procedures.
- Support effective and timely root cause investigations as needed.
- Train operators on procedures and equipment.
- Minimum 8 years of related industry experience in the manufacture or development of FDA regulated Biological products.
- Clinical or commercial manufacturing experience preferred.
- Experience working in aseptic environment preferred.
- Broad based technical knowledge with manufacturing equipment (i.e. bioreactors, mixers, and lyophilizer).
- Experience with toxin manufacturing a plus.
- Demonstrated troubleshooting skills and mechanical aptitude.
- BS degree in biological sciences, chemical engineering or related discipline
- Ability to work effectively in a team environment.
- Excellent organization skills.
- Excellent communication skill (written and oral).
- Ability to handle multiple projects at one time.