Lead Manufacturing Support Specialist

Work Schedule First Shift (Days) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Warehouse, Will work with hazardous/toxic materials, Working at heights Job Description When youu2019re part of the team at Thermo Fisher Scientific, youu2019ll do important work. And youu2019ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. Discover Impactful Work: Through Unity Lab Services, we offer integrated lab services, support, and supply management with customized service offerings and world-class experts to address our customers' unique laboratory business needs. The Lead Manufacturing Support Specialist performs a wide range of materials management inventory and coordination activities supporting Vertex's materials supply chain. This position will primarily support the manufacturing facility located in the Cambridge, MA and Boston locations. This role is required to perform and document daily warehouse operations in a cGMP environment. A day in the Life: + Receive and inspect materials in accordance with SOPs. + System: Oracle, Veeva, Coupa, Lims (samples) + SOPu2019s: SOP-0964 + Decision making: transfer material on plastic pallets, inspect material for damage, verify physical material to material specification (TDS), receive PO in Coupa, remove cardboard and throw in compactor, fill out receiving forms (SOP-0964A and SOP-0964B), receive item In Oracle, print labels from Oracle, label all material down to the smallest unit possible, place material in correct temperature condition according to material specification, utilize forklift and order picker to put material into racking. + Pull Sample/Retains for incoming material + System: Oracle, Lims, Veeva + SOPu2019s: SOP-0964, SOP-1009, SOP-0798 + Decision making: Follow material specification on the number of samples and retains that are required per item, Place samples and retains under lock and key for storage, fill out retain logbook and sample submission form, ensure samples and retains are transacted out of the system, coordinate delivery with QC and send samples at appropriate temperature + Transfer of materials to and from the warehouse using an effective workflow. + System: Oracle, Temperature Controlled Truck/Unit (TCV), Temperature Monitors + SOPu2019s: SOP-1280 + Decision making: Coordinate with receiving warehouse on deliveries, Set the TCV unit to the correct set point, prior to loading ensure TCV is within loading range, fill out SOP-1280A logbook to record time and temperature, start temperature monitor and load with material, once TCV is back in range and material loaded drive to destination, record required information on SOP-1280A logbook at receiving site, unload and stop temperature monitor, ensure it did not alarm, have paper work signed (SOP-0964C) for proof of delivery and return to distribution center. + Lead all the daily ERP requests such as material transfers and production requests. + Store materials in appropriate GMP conditions according to material TDS + System: Oracle, Veeva + Sop-0964 + Decision making: Store material in the correct GMP conditions utilizing Veeva to retrieve the material specification (TDS). Following TDS for storage condition and storing the material correctly in Oracle (systematically and physically) + Confirms the completion and tracking of supply chain supply-related documentation + Must be proficient in the use of the inventory management system (ERP) + System: Oracle + Sopu2019s: SOP-0964, SOP-1108, WI-0835 + Decision making: execute real time transactions for material transfers, material receipts, material issuing, batch creation, manual consumption, and IRISO transactions + Assist in working with Freight Forwarders, 3PLs, Brokers and Direct Carriers to address logistics issues and needs. + System: World Courier, Fedex Custom Critical + SOPu2019s: SOP-0964 + Decision making: Working with World Courier and Fedex Custom Critical to schedule shipments, ensure the appropriate temperature is requested for items shipping domestically or internationally, work cross functionally with logistics to have all required custom documentation is accurate and clears customs within a timely manner + Work with various cross-functional groups (such as Quality, Tech Ops, Regulatory, suppliers, etc.) to proactively and collaboratively resolve issues that may block the timely flow of materials or projects + System: Oracle, Veeva, Coupa + Sopu2019s: N/A + Decision making: Some examples - Escalate if items are being requested for production but are in quarantine status, escalate to procurement team on missing documentation or damaged products from suppliers, material shortages, escalate information to management if needed + Review data from temperature monitoring devices and EMS as appropriate. Investigate and resolve any temperature excursions. + System: Visala (ViewLinc EMS), Sensitech Temperature Monitors + SOPu2019s: SOP-0964, VV-QUAL-112935 + Decision Making: Escalate temperature excursions from temperature monitors to management, acknowledge u201cwarningsu201d in Visala and escalate alarms. Be a representative in triage meetings for alarms as necessary. + Following cGMP procedures, retrieve documents from the document management system + System: Veeva + SOPu2019s: All + Decision making: Retrieve SOPu2019s and forms from Veeva. + Complete cGMP documents using good documentation practices + System: Veeva, and GMP forms + SOPu2019s: VV-QUAL-40763 + Decision making: Follow VV-QUAL-40763 for good documentation practices + Monitor the cycle count program, activities and results to identify necessary recounts and processes to be monitored and provide updates to senior management + System: Oracle, Veeva + SOP-0830 + Decision making: Cycle count inventory based on material class, record any discrepancies on SOP-0830A form, notify management if a 5% discrepancy per lot is noted during cycle count, adjust in Oracle after cycle count is complete and signed off by management + Help to develop shipment schedule and prepare and transact all Clinical, Commercial product and sample shipments + System: Oracle, Veeva, + SOPs: SOP-0964, SOP-1280 + Decision making: Coordinate deliveries with Cambridge, Liden Center, and Fan Pier sites. Ensure driver knows where and when to deliver, print out pending SOP-0964C requests and run availability in Oracle, transact all pick slip when material has been picked and verified + Coordinate and participate in on-call program to provide emergency coverage in the event of asset outage or other unplanned events. + Manage min/max inventory levels + System: Oracle, Veeva + Sopu2019s: SOP-0964 + Decision making: Run min max report in Oracle daily, fill out SOP-0964C form and request items below the min level, coordinate with distribution center on delivery date and time, escalate emergency requests to management + Assess expiry + System: Oracle + SOPu2019s: SOP-0964 + Decision making run report in Oracle monthly, obtain planning approval on items that can be discarded, coordinate with EH&S on waste disposal + Procure, inventory, and handling of bulk gases + System: Coupa, Oracle + SOPu2019s SOP-0964 + Decision making: Procure gasses in coupa dependent on manufacturing schedule, receive gasses in Oracle and coordinate with QC and QA on release, apply tanks to LN2 stations for cryo tanks, cryo pod filling stations, CRFu2019s as needed, return empty tanks to air gas. + Kitting material non-MES and MES enabled batches + System: Oracle, MES + SOPu2019s: SOP-0964 + Decision making: Run move orders depending on production schedule, ensure items are kitted in appropriate bins and labeled as the move order ID, scan material to staging locators and move them physically to the 4th floor. Help with any MES issues with manufacturing. + Gowning and spraying material into clean rooms + System: Oracle + SOPu2019s: SOP-1214 + Decision Making: Follow SOP-1214 when gowning is required in manufacturing areas, Spray in material for manufacturing and move them into the appropriate suite physically and systematically, ensure all MAL in and pass through area are clean and organized + Oversee day-to-day scheduling and coordination of daily material deliveries to external Vertex sites. Utilize Oracle to complete requests for materials and subsequent deliveries. Ensure materials are shipped in correct conditions. + Train employees in supply chain basics + Advise as needed on processes/procedures within the materials management department, including GMP raw materials, inventory control, cell bank storage, product shipments and ERP stability + May represent Supply Chain department on assigned project sub-teams and/or task forces as a key support resource; may help execute supply chain production activities + Safely operate all motorized equipment including forklift trucks, electric pallet jacks, lifts, and company vehicles. Keys to Success: Education High school diploma or secondary school diploma. Experience Typically requires 4 years of experience or the equivalent combination of education and experience Knowledge, Skills, Abilities

Created: 2026-03-16