Oversee product development and compounding processes.
Ensure that procedures are followed and consistent with cGMPs.
Assists with additional work duties or responsibilities as evident or required.
Performs other duties as assigned or apparent.
NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.
Periodically review batch records, SOP’s, and other cGMP documents.
Optimize and enhance existing production processes.
Identify and supervise development of new projects.
Monitor the compounding process to ensure that procedures are adequately followed and that product quality is of the highest standard.
Participate in product trend analysis.
Assist in investigations related to non-conformances.
Assist in the implementation of corrective and preventive action plans.
Assist with applications to regulatory bodies.
Provide expertise and testimony of compounding operations as needed during regulatory inspections.
Assist in the drafting and review of protocols designed for product development and/or validation.
Knowledge, Skills & Abilities:
PharmD required…Pharmacist must be licensed and registered with the state of South Carolina. Multiple state licenses preferable.
Knowledge of general sterile compounding practices.
Computer experience (Microsoft Word, Excel, and Power Point).
Clear communication skills.
Specific expertise, skills and knowledge within research, development, and sterile compounding gained through education and experience.
A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.
The ability to take strategic objectives and accept accountability to drive results through effective actions.
The ability and willingness to change direction and focus to meet shifting organizational and business demands.
The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.
The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
The ability to effectively manage one’s self, demonstrate integrity, be productive under pressure, and achieve development goals.
The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.
The ability to manage a multitude of resources and to be accurate and current with data and information.
The ability to create new products and processes that add value to the Business by generating new ideas and applying creative and analytical approaches.
Position requires typing, climbing, lifting (up to 15lbs), reaching, vision (20/20), standing, sitting, walking, and hearing.
Salary range: Based on experience