Formulations Technical Specialist

Our BusinessAdare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines. By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliver potentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind “Transforming Drug Delivery – Transforming Lives.” Our CultureWhen it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space. In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day. Why Come to Adare?Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare’s investment in their growth. We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage.   Position Formulations Technical Specialist Location Vandalia, OH SummaryThe Formulations Technical Specialist is responsible for supporting projects by developing and maintaining the necessary documentation and tasks required to fulfil project needs. This person will work alongside project teams to drive activities, accelerate timelines, offer ideas to implement future enhancements/work efficiencies, and provide adequate quality oversight and expertise for the creation and review of internal quality documents.   Responsibilities Managing Clinical and Registration Batch Preparation and execution.  Responsibilities include: Initiate and retain stability samples per SOP procedures  Scheduling clinical batch execution with R&D, Logistics and Operations  Facilitate batch record training with Operations and R&D Responsible for the initiation and completion of System Change Controls. Managing actions with multiple departments, reviewing, approving action items until completion and Change Control closure. Serving on the Quality Systems Action Board as the R&D Formulations representative Overseeing the qualification of project raw materials by working with Supply Chain and the Global Quality department with updates on project status and material management from project conception to GMP manufacturing.  Contribute to the creation and/or review of project DMF and/or other Regulatory documents as needed Generating and approval of accurate and detailed GMP batch records for clinical trial supplies through Registration manufacturing.  Generation and revision of SOP, Work Instruction, and Controlled Forms, to support R&D processes Managing the procurement of raw materials for both formulation development and GMP batch manufacturing following the necessary procedures in order to meet aggressive timelines  Detailed management of formulation projects, processes, and procedures to support Formulation Scientists meet aggressive timelines Implement procedural changes to existing internal systems to gain efficiencies to get products to clinical trial status earlier by working with Quality Assurance as well as other departments to implement change   Participates in the development and implementation of methods, procedures and regulations necessary for the smooth operation of the business. Other miscellaneous tasks as required      Experience, Education, and Skills Required B.S. in Pharmaceutical Sciences, Biochemistry, Chemistry, Chemical Engineering, or a related discipline 3+ years of relevant industry working experience. Strong understanding of GMPs and associated FDA regulations A basic understanding of pharmaceutical formulation development A basic understanding of laboratory analytical equipment   Physical Demands Stand, walk, push, pull, twist, reach overhead, and bend to the floor. Occasionally move items or equipment weighing up to 30 pounds – potential to handle heavier materials with mechanical assistance. Occasionally required to climb ladders and/or steps to reach equipment. Reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope. Must have ability to wear a respirator in order to work with chemicals of a specified potency level     Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. PRINCIPALS ONLYNO AGENCIES OR THIRD PARTIES