What We’re Looking For
The Director of Pharmacy is responsible for overseeing research and development (R&D) and medication production at Wilcrest Pharmaceuticals. This role requires a strategic leader who can manage and coordinate R&D projects, ensure high-quality production of medications, and develop and implement standard operating procedures (SOPs).
What You Will Do
- Oversee and manage all aspects of research and development (R&D), master formulation records, and medication production for sterile and nonsterile medications
- Develop and implement operational systems that ensure compliance with CGMP requirements and optimize production efficiency and safety
- Provide scientific and business leadership to ensure R&D projects meet customer and business goals in terms of cost, quality, and turnaround time
- Analyze key metrics to drive process improvements and ensure quality product output
- Collaborate with executive management and other directors to set strategic goals and align operations with company objectives
- Develop, implement, and optimize standard operating procedures (SOPs) for medication production
- Collaborate with the Quality Unit to set specifications for medication components
- Hire, train, and mentor production technicians to build a high-performing team
- Working closely with the Director of Operations and Director of Quality to align medication production with company objectives and regulatory standards.
- Support quality assurance efforts to maintain product integrity and customer satisfaction
- Manage and submit semi-annual product reports to FDA
- Ensure compliance with all relevant FDA, DEA, and state regulations and guidelines
- Coordinate with cross-functional teams to support new product launches and facility expansions
Who You Are
- Doctor of Pharmacy or bachelor’s degree in pharmacy
- Five years of experience in sterile pharmaceutical manufacturing or sterile compounding and formulation development
- Three years of management experience
- Proven track record of managing sterile production operations in a regulated environment
- Strong leadership skills with the ability to motivate and guide a team, and partner with cross-functional team members.
- Excellent communication, organizational, and problem-solving abilities
- Proven history of knowledge of FDA regulations pertaining to pharmaceutical manufacturing and 503B outsourcing facilities
- CGMP experience preferred
Physical Requirements
This position involves access to controlled substances and hazardous drugs and as such anyone who has been convicted of a felony or within the past two years any misdemeanor, or is currently charged with committing a criminal offense, is not eligible and will not be considered.
Any person that has knowingly used any narcotic, amphetamine, or barbiturate, other than those prescribed by a physician, is not qualified for this position.
Who We Are
Wilcrest Pharmaceuticals is a leading 503B outsourcing facility dedicated to providing high-quality compounded medications. We are committed to excellence in manufacturing practices and patient safety.