GMP Manufacturing Tech - 168144
The GMP Technician will stock, move, clean, stage, kit, and dispose of materials required for multiple cGMP manufacturing facilities which produce cGMP cell bank, drug substance, and drug product human clinical supplies; and complete daily/weekly/monthly facility support and upkeep tasks for early phase cGMP manufacture of materials for use in human clinical trials of HIV-1 and other infectious disease candidate vaccines. This position will be responsible for execution of various cGMP logistics tasks required to support a large portfolio of products
RESPONSIBILITIES:
- Collaborates closely with the cGMP Materials & Logistics lead to provide daily on-site support for cGMP materials movement and facility logistics needs. Maintains all general materials required for cGMP production, including receiving materials, unboxing materials, stocking materials, labeling materials, moving materials throughout various cGMP facility spaces, cleaning materials into the facilities, staging materials, kitting materials for production use, completing physical inventories, and performing basic data entry tasks for material inventories. Abides by 5S organization of supplies/materials throughout the cGMP facilities. Routinely organizes areas to keep all work and storage areas tidy, adequately segregated, and ensure First In First Out (FIFO) is maintained.
- Maintains cGMP facilities on a daily/weekly/monthly/quarterly basis, through the performance of routine suite duty tasks. Areas to maintain include production areas, controlled storage areas, and uncontrolled support areas. Basic equipment use, good documentation practices (GDP), and the ability to manage a cadence of task execution will be required for this role. Performs routine instrument upkeep, standardization, and kit change out for cell culture equipment (i.e. ViCells, Nova Bioprofiles, etc). Completes weekly WFI drop and eye wash station flushes throughout the facility. Performs weekly autoclave and washer maintenance cycles. Changes out washer CIP chemicals as needed. Assists production staff during manufacturing to complete pH meter, conductivity meter, scale, and turbidity meter daily standardizations/checks. Performs pre/post-use BSC cleans during manufacturing campaigns, as needed. Stocks cGMP gowning and cleaning supplies daily in all production facilities/support areas. Removes/replaces soiled tacky mats throughout production and support areas daily. Removes soiled gowning and process waste daily in all production facilities/support areas. Cleans in all materials/equipment for production facilities in accordance with Standard Operating Procedures (SOPs).
- Operate drum lifters, pallet jacks, carts/dollies to pick up and deliver materials and supplies according to priority of need or a predetermined schedule. Receive and unpack shipments and verify contents against purchase orders and invoices; record receiving reports on all merchandise; prepare reports concerning shortages and damaged materials received; store material according to established procedures. Load and unload materials by hand or pallet jack/drum lifter; transport and transfer supplies and equipment from one storage area to another; pull stock to fill requisitions for the cGMP facilities as directed and complete the relevant forms in accordance with SOPs.
- Assist in inventory of materials and gases. Assist in special and scheduled material inventories; inform materials & logistics lead of various stock levels and assist in maintaining outstanding orders. Generate material inventory/tracking documents using computers, printer hardware and inventory management software in accordance with SOPs. Perform clerical and manual tasks in receiving, verifying, storing, issuing, and shipping various materials in accordance with established SOPs. Maintain outstanding order, purchase order, receiving, requisition, delivery, and shipping files; conduct special and scheduled material inventories and audits of records; provide supervisor with receiving and shipping activity reports. Receive outgoing shipments returned for credit, exchange or repair; pack merchandise for shipping; ensure merchandise is properly packed and shipped by advising external parties involved in packing and by arranging with transport companies for pick up and delivery of materials/equipment.
- Perform other related duties as necessary and requested by GMP leadership.
Required Qualifications at this Level
- Education/Training: Work generally requires a bachelor's degree in science, engineering, or related field.
- Experience: None required above education/training requirement. Prefer up to two years of laboratory experience, preferably in a GMP/regulated environment. A related master's degree may substitute for two years of experience.
KNOWLEDGE, SKILLS, & ABILITIES:
- Must be self-motivated, detail-oriented, drawn to routine, well organized, have strong communication skills and ability to work in an interactive team environment.
- Must have the ability to problem solve and operate independently, yet escalate when necessary
- Must be able to learn and apply technical procedures located in Standard Operating Procedures (SOPs)
- Must be able to lift/carry/move cGMP materials weighing up to 50lbs and occasionally ascend ladders to store cGMP materials
- Must demonstrate the highest degree of ethics and integrity at all times