Job Title : Manufacturing Technician IV
Reports to : Supervisor / Manager, Manufacturing
Summary : The Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level
provides an opportunity to stay on the technical track, or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following :
Upstream Unit :
- Single-Use Cell Culture Vessels / Bioreactors up to 2000L
- Bacterial Fermentation Culture Vessels up to 2000L
- Alpha Wasserman Continuous Flow Centrifuges
- Disposable Magnetic Mixing Bags and Totes
- Cell Expansion and Propagation
- Banking / Cryopreservation of Cell Lines and Viruses
- Hyperstack, Cellstack, and other Adherent Cell Technologies
- Plate counting, microscopic examination
- Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation
Downstream Unit :
Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtrationMedium to Large-scale Chromatographic systems (ÄKTA).Pre-Packed Columns from 1L to 100LSingle use mixing systems (Pall & GE)Single Use connectivity types such as GE DAC and Colder AseptiQuikBulk fillingAseptic process simulation and drug product fillingPlate counting, microscopic examinationMonitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculationBuffer Preparation Unit :
Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needsPreparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needsWeighing of raw materials per batch record specifications and assignment of appropriate expiry per proceduresIntegrity testing of filtersEssential Functions Include :
Write and review standard operating procedures, buffer formulation records and batch production records.Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.Maintain the confidentiality of proprietary company information.Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales,pH / conductivity meters, etc.
Perform daily cleaning and sanitization of the laboratory and manufacturing areas.Maintain an effective working relationship with others.Perform all other duties as assigned.Technician IV - Supervisory Track Option :
Successfully leads two or more projects at a time.Perform as the Subject Matter Expert (SME) on a variety of projects and range of technologies.Assists with onboarding new employees into the team.Assists Sr. Training Specialist with training needs of department.Responsible for maintaining the schedule and successfully coordinating with other departments.Required Skills & Abilities :
Excellent oral and written communication skills, interpersonal and organizational skills.Proficient with Microsoft Office applications.Excellent leadership skills.Ability to train others to perform to cGMP standards.Good self-discipline and attention to detail.Must be able to work flexible shifts to include weekend or night shifts, and be willing to work outside of normal scheduled hours to meet the demands of the business.Excellent math and computer skills.Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities.Working Conditions & Physical Requirements :
The physical demands described here are representative of those that must be met by an employee to successfully
perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to :
Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders, and stretching.Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.Ability to wear personal protective equipment including safety glasses, lab coat, safety shoes and gloves.Ability to lift / push / pull up to 25 pounds frequently and up to 50 pounds occasionally.Attendance is mandatory.Technician IV Minimum Qualifications :
Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 2 years of relevant experience; ORAssociates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 4 years of relevant experience; ORHigh School / GED with 6 years of relevant experience.
