Formulation Technical Specialist

Adare 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 Culture When 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 Summary The Formulations Technical Specialist is a key member of the Formulations team, responsible for management of stability samples, scheduling clinical batch execution, handling department change controls, and SOP writing and revision. This person will be expected to come with working knowledge of solid oral dosage form (tablets and capsules), and will work alongside project teams to drive activities, accelerate timelines, and offer ideas to implement future work efficiencies. 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 Generate and approval of accurate and detailed GMP batch records for clinical trial supplies through Registration manufacturing. Generation and revision of SOP, Work Instruction, CTM checklist and Controlled Forms, to support R&D processes Support scientists in 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 Implement process improvements to get products to clinical trial status earlier; work with Quality Assurance and 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 projects and 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 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. #J-18808-Ljbffr Adare Pharma Solutions