Pharmacist

This position is responsible for overseeing the preparation of sterile products under cGMP and related activities under the direction of the Director of Pharmacy. Focuses on quality, safety, and efficiency during production, ensuring compliance with industry standards and guidance. Collaborates with Quality, Manufacturing Sciences & Technology, Sales and Marketing, and external labs to support product development activities across sites. Licensed pharmacist in multiple states, with knowledge of pharmacy regulations, quality standards, and best practices to oversee the production and distribution of high-quality medications.

SAFETY Strictly adheres to all regulatory requirements, health and safety (e.g., OSHA, EPA, RCRA) requirements, procedures, work instructions, and corporate policies.Immediately stops any task that is determined to be an imminent hazard.Promotes and demonstrates safe work practices and adhere to PPE requirements.Safely handles chemicals, corrosives, solvents, and other pharmaceutical compounds.Demonstrates physical ability to lift a minimum of 35 lbs. PRIMARY RESPONSIBILITIES Ensure full compliance with all applicable federal, state, and local regulations, including the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) requirements, as well as state pharmacy board regulations for 503B outsourcing facilities.Oversee the compounding process to ensure accuracy, consistency, and adherence to established procedures, including supervision of operations personnel. Participates in compounding and formulation of sterile preparations, using proper technique and following Standard Operating Procedures. Performs review of formulation batch records to verify execution of all steps according to internal procedures.Collaborate with Manager of Product Development, internal departments, and outside labs to coordinate and support research and product development activities across sites. Develops or updates cGMP documents including batch records, procedures, work instructions, change controls, and protocols. Conduct investigations related to quality assurance, deviations, and out-of-specification results.Provides guidance and training to operations personnel and other departments as needed. Provide professional support to healthcare professionals and customers, addressing inquiries related to compounded medications and regulatory requirements.Other duties as assigned

Promotes a culture of safety throughout the facility, ensuring compliance with all health, safety, and environmental regulations.Demonstrates integrity by maintaining high ethical standards and treats all employees with trust, respect, and professionalism. Fosters a collaborative work environment, promoting teamwork, and building strong cross-functional relationships. Demonstrates flexibility to navigate changing priorities, and evolving industry regulations. Demonstrates emotional intelligence with ability to understand and manage emotions, both in oneself and others, fostering positive relationships.

Doctor of Pharmacy (PharmD) degree from an accredited pharmacy program.Active and unrestricted Pharmacist License in the state of operation (Ohio). Able to obtain licensure in additional states as required.Knowledge of FDA regulations, cGMP guidelines applicable to 503B outsourcing facilities, USP General Chapters and Monographs.Excellent written and verbal communication skills.Highly skilled in Microsoft Office (PowerPoint, Excel, Word).

Experience working at a 503B Outsourcing Facility.Detail oriented, well organized, and strong planning skills.Ability to read, analyze and interpret scientific and technical information.Experience working with FDA, State Boards of Pharmacy, and regulatory authorities.