Formulations Technical Specialist

Formulations Technical Specialist

The 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 Only No Agencies Or Third Parties