Cell Culture Manufacturing Operator Wed-Sat

This position is responsible for providing support to their respective process team per Manufacturing Standard for Operational Excellence (MSOE) 602, specifically focusing on safety, quality and manufacturing performance. 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 Bio Services). 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. Bio Services 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.

• Responsible for providing support to their respective process team, per Manufacturing Standard for Operational Excellence (MSOE) 602.
• Record data, log activities, and monitor processes according to cGMP standards.
• Perform general maintenance and assists in troubleshooting of equipment.
• Review batch records for completeness and accuracy.
• Author and/or revise standard operating procedures and batch records. May participate in non-conformance event investigations and/or change controls.
• Maintain an elevated level of safety awareness. Communicate safety issues to management in a timely manner.
• Strict adherence to all company safety policies including the use of PPE where required.
• 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.

Basic Requirements:

• Minimum of 2 years of relevant experience, Ability to understand technical nomenclature and language as well as work with mathematical formulas.
• 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:
• Lifting of 50 pounds
• Bend, reach, stretch, climb ladders, and work in tight spaces.
• Stand for long periods.

Education Requirements:

• Minimum HS degree with 2-4 years’ work experience

This role is nonexempt and the anticipated compensation for this role is $39,750 - $88,750.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role does not require travel but does require the ability to lift up to 50 lbs., on-call availability, and may involve shift work.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.