Formulations Technical Specialist

Formulations Technical Specialist

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.

PRINCIPALS ONLY NO AGENCIES OR THIRD PARTIES