Perform actual duties in an assigned area within the biopharmaceutical bulk products production facility. Duties are listed below and are specific to the assigned area (Cell Culture, Purification, or BioServices). The processing areas are PLC automated and controlled via HMI. Cell Culture operations contains major equipment such as bioreactors, centrifuges, and biosafety cabinets. Protein Purification operations contains major equipment such as chromatography columns, chromatography / TFF skids, and intermediate product vessels. BioServices encompasses Media Prep, Buffer Prep, and general equipment cleaning and preparation supporting both Cell Culture and Purification. Major equipment for this area includes stainless steel vessels, autoclaves, and washers. All three major manufacturing departments utilize filtration technologies.
- Prepare and operate equipment according to written procedures. Examples include: setup and sterilization of components and process equipment, monitoring equipment parameters and making adjustments to operational settings, in-process sampling, and performing routine assays
- Record data, log activities, and monitor processes according to cGMP standards.
- Perform general maintenance and troubleshooting of equipment
- Review batch records for completeness and accuracy
- Author and/or revise standard operating procedures and batch records. Participate in non-conformance event investigations and/or change controls
- Train junior/new operators
- Serve as a leader on the floor. Demonstrate the ability to analyze technical issues and suggest mitigatation/resolution to supervisor. May represent area in cross-functional meetings.
- Maintain an elevated level of safety awareness. Communicate safety issues to management in a timely manner.
- Adhere to all safety, environmental, quality, and EEO/AA standards and policies of the Corporation
- Perform all duties with a high level of honesty and integrity.
- BA/BS in biology, chemistry, or related discipline, or equivalent work experience.
- Minimum of 5 years of relevant experience, or a minimum of 2 years high performance as Operator III.
- Demonstrated high level of technical understanding within functional area.
- Have a functional understanding of a second discipline within the production group
- Must have good manual dexterity and demonstrated mechanical aptitude
- Must be able to follow detailed instructions and record information clearly and accurately
- Must possess excellent communication, interpersonal, and written skills
- Demonstrated knowledge and experience in aseptic processing techniques
- Must be able to apply technical and operational experience to aid in problem solving activities.
- Must meet the physical requirements of the job; must have the ability to:
- Lift a minimum of 50 lbs.
- Bend, reach, stretch, climb ladders, and work in tight spaces.
- Stand for long periods.
- Wear appropriate clean room attire.
ImClone Systems Incorporated - 10 months ago
ImClone Systems Incorporated (ImClone) is a biopharmaceutical company that develops a portfolio of targeted biologic treatments designed to...