Formulations Technical Specialist

Position

The Formulations Technical Specialist position is located in Vandalia, OH.

Responsibilities

• Manage Clinical and Registration Batch Preparation and Execution
• Initiate and retain stability samples per SOP procedures
• Schedule clinical batch execution with R&D, Logistics and Operations
• Facilitate batch record training with Operations and R&D
• Manage System Change Controls, reviewing, approving action items until completion and Change Control closure
• Serve on the Quality Systems Action Board as the R&D Formulations representative
• Oversee the qualification of project raw materials by working with Supply Chain and the Global Quality department
• Contribute to the creation and/or review of project DMF and/or other Regulatory documents as needed
• Generate and approve accurate and detailed GMP batch records for clinical trial supplies through Registration manufacturing
• Generate and revise SOP, Work Instruction, and Controlled Forms, to support R&D processes
• Manage the procurement of raw materials for both formulation development and GMP batch manufacturing following the necessary procedures
• Support Formulation Scientists in meeting aggressive timelines
• Implement procedural changes to existing internal systems to gain efficiencies
• Participate in the development and implementation of methods, procedures and regulations necessary for the smooth operation of the business

Requirements

• Bachelor's degree 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
• Basic understanding of pharmaceutical formulation development
• 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
• 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

Benefits

• 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)
• Disability coverage

Qualifications

• 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