Shift: 3rd, Wed – Sun, 6:00pm – 4:30am
Job Title: Manufacturing Associate I
Duties: Performs production processes for GMP manufacturing operations. Operates large and small scale bioprocess equipment for the cell culture and purification processing. Executes routine unit operations in Cell Culture or Purification as assigned related to the manufacturing of bulk drug substance in a multi-product facility. This may include tank or bioreactor CIP/SIP, cell inoculation and transfer, harvest, chromatography, and tangential flow filtration. Performs duties under limited supervision and according to standard operating and manufacturing procedures. Position will be on graveyard (2000-0630).
Executes routine unit operations in Cell Culture /Purification such as bioreactor inoculation, cell separation, chromatography and tangential flow filtration as well as Clean-In-Place (CIP) and Steam-In-Place (SIP) operations. Practices ergonomic safety and use appropriate personal protective equipment (PPE) in all operations.
Performs in-process analytical instrument measurements of e.g. pH, cell viability and viable cell density, osmolality, gas content, metabolites, spectrophotometry, or conductivity.
Documents execution of operations through the Bio Manufacturing Execution System (BioMES), batch record and equipment use logbook using Good Documentation Practices (GDP).
Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
Reports any issues related to manufacturing performance, process and safety to the team lead or Manager in order to ensure safety and compliance with regulations and cGMPs and to facilitate continuous process improvement.
Adherence to GMP training schedule and responsible for achieving all training requirements within acceptable timelines.
Performs routine housekeeping of the manufacturing plant using the 5S organization methodology by using appropriate equipment safety signage, labeling of parts-in-process, sweeping water pools to the floor drain, and picking up parts from the floor.
Unit operations described in standard operating procedures and batch records.
Recognizes and corrects errors in bioprocess operations prior to failure.
Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency.
Performs review of GMP documentation.
Completes required processing documentation including, product change over and other documentation.
Reviews and signs executed process and solution MBRs.
Ensures acceptable quality and quantity of work executed.
Ensures that standard operating procedures (SOPs) are followed and are correct for bioprocess operations and equipment.
Ensures compliance with company quality systems, safety procedures, and other company policies.
Judgment required to apply industry practices and company policies to daily operations.
1+ years of experience in a biotech manufacturing environment or other regulated cGMP manufacturing facility and a Bachelor's degree in science related area or engineering or Associate's degree in science related area or Biotech certificate or in lieu of Education requirements 3 years of experience in cGMP manufacturing environment.
Display competency with process equipment and automated control systems
Working experience with GMP manufacturing regulations.
Working knowledge of manufacturing equipment and technology
Knowledge of biotech manufacturing process and equipment including cell culture, depth and tangential flow filtration, column chromatography, protein purification and formulation
Experience in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
Ability to understand, apply, and evaluate basic chemistry, biology and scientific principles as appropriate for the position.
Communicate, read, and write legibly in English.
More advanced computer skills including work with spreadsheet programs (Excel) and word processing (Word).
Manages time effectively.
Detail oriented with the ability to complete written and verbally assigned tasks following specific instructions and procedures.
Ability to interact constructively with peers and support groups
Organizational and communication skills necessary to ensure daily work plan is executed