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Pharmacy Operations Director

1 month ago

Houston, Texas, United States Wilcrest Pharma Full time

Wilcrest Pharma Job Opportunity

The estimated salary for this role is $120,000 - $160,000 per year.

About the Role

We are seeking an experienced Director of Pharmacy to oversee our research and development (R&D) and medication production operations. This individual will be responsible for managing and coordinating R&D projects, ensuring high-quality production of medications, and developing standard operating procedures (SOPs).

Main Responsibilities:

  • 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 drive R&D projects towards 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 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
  • Work 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

Requirements

To be successful in this role, you will need:

  • A 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
  • A 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
  • A proven history of knowledge of FDA regulations pertaining to pharmaceutical manufacturing and 503B outsourcing facilities
  • CGMP experience preferred

Company Overview

Wilcrest Pharma is a leading 503B outsourcing facility dedicated to providing high-quality compounded medications. We are committed to excellence in manufacturing practices and patient safety.