The Sr. Forumulation Technician is responsible for the formulation, filling, capping, labeling, and kitting of all existing and new reagent products. This position is also solely responsible for calibration, maintenance, and operation of all lab equipment. This position will work closely with R&D for the transfer of new formulations into Reagent Manufacturing. Works very closely with colleagues to maintain a clean and organized laboratory environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Perform assigned duties according the weekly production schedule. Complete weekly report of work completed, forward to Manager every week at a designated time.
- Formulate and filter bulk solutions using sterile technique according to manufacturing instructions. Test solutions for pH, Conductivity, and Osmolality.
- Fill, cap, label, and kit reagent products according to manufacturing instructions using manual and automated systems. Record filling and kitting events in log in real time.
- Maintain all lab equipment preventive maintenance and calibration; including but not limited to the pH/Conductivity meter, Osmometer, CVC Horizontal Labeler, Tube Auto Capper, Biomek filling device, Hamilton filling device, Milli-Q water system, hoods, freezer/refrigerators, pipettes, spectrophotometer, NanoDrop.
- Support QC testing and release of reagent products as assigned.
- Write, revise, and implement Equipment Procedures for all equipment; Manufacturing Instructions for new and existing reagent products; and Standard Operating Procedures for standard lab practices.
- Work with R&D groups to transfer new formulations into production, build pilot lots of material, and create manufacturing documentation.
- Perform accurate cycle counts on monthly and quarterly basis.
- Order lab supplies and manufacturing materials as needed or directed by Manager. Complete and obtain approval for purchase requisitions. Receive, log, and stock material upon receipt.
- Forward material to logistics to support reagent internal consumable requests.
- Follow all established lab procedures both documented and undocumented. Complete all paperwork using good manufacturing practices.
- High School diploma with minimum 5+ years of experience in a laboratory setting; College degree preferred.
- Experience operating lab equipment (Osmometer, pH/Conductivity meter, Spectrophotometer instruments, pipettes, filling devices, etc.)
- Experience in reagent preparation and proficiency with common laboratory tools and techniques.
- Experience working in a cGMP or ISO laboratory environment.
- Ability and willingness to perform repetitive tasks such as manual filling, capping, labeling, and kitting.
- Ability to calculate chemical formulations and follow reagent recipes and protocols
- Strong organizational skills and attention to detail
- Proficient with Microsoft Word, Excel, Outlook. Ability to learn and use other software such as Saleforce.com, PDM, ADP.
- Dedication to total product quality and a safe working environment.
- Self-directed, organized, and possesses good judgment.
- Team player.
- Ability to lift weights in excess of 25 lbs above the shoulder on a regular and unsupervised basis
- Excellent oral and written communication skills.
- Works alongside fellow manufacturing personnel.
- Reports to Reagent Manufacturing Manager.
- Indirectly reports to the Associate Director of Consumables Production.
- QA for the creation and modification of all documents and lab processes.
- QC for in-process and final release testing of reagent products.
- R&D for transfer of new reagent products into production and troubleshooting of existing reagent products.
- Logistics for transfer of inventory and internal consumable request items.