Pharmacy Consultant

Medisca is a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30+ years and a strong foundation in pharmaceutical compounding, Medisca is a business-to-business company that delivers comprehensive offerings by providing value, consistency, responsiveness, and loyalty. From pharmaceutical compounding products and services, to supply chain solutions, mixing technology manufacturing, analytical testing, IP licensing, to education services and more – Medisca delivers extensive solutions that leverages a strong network of partners committed to deeply caring about people. As Partners in Wellness, Medisca offers an unfailing devotion to improving lives, across a multitude of needs and across a multitude of people.

The primary goal of the Pharmacy Consultant is to be a subject-matter expert to both Medisca’s cross-functional teams, as well as to external clients for all Compounding Pharmacy  (503A) and Outsourcing Facility (503B) business needs. The incumbent will be interacting with internal teams and clients to provide direction and support on both non-sterile and sterile compounding. They will focus on the development, design and implementation of formulations,  day-to-day formulation troubleshooting, specialized consultations (facility design, regulatory compliance, cGMP, environmental monitoring, quality assurance, validation and qualification, aseptic processing, niche areas of practice and more), continuing education and our product portfolio (technology, equipment, reusable/disposable supplies and ready bases), as it pertains to 503A and 503B business needs.

You have:

• Comprehensive knowledge of DQSA, applicable FDA Guidance, DEA regulations, 21 CFR Part 210 and 211 and USP.
• Comprehensive knowledge of current standards of practice in non-sterile compounding; USP <795> required.
• Comprehensive knowledge of current standards of practice in sterile compounding; USP <797> required.
• Ability to function as a subject-matter expert and consultant in the following areas (non-exhaustive list):

• Product Specialist (technology, equipment, reusable/disposable supplies and ready bases).
• Procurement of products, equipment and devices for the 503B Outsourcing Facility.
• Automated technology and robotics.
• Quality systems.
• Quality assurance and quality control.
• Continuous quality improvement.
• Aseptic processing.
• Process validation.
• Analytical and microbiological testing.
• Facility design.
• Environmental management and monitoring.
• Sanitary conditions.
• Operational support and workflow.
• Mock audit.
• Formulation development.
• Batch production and master formulation review.
• FDA Product submissions.
• Standard operating procedure customization and review.
• Pharmaceutical calculations.
• Niche areas.

• Ability to function as an onsite third-party evaluator.
• Demonstrated ability as a technical expert in non-sterile processes, servicing and training.
• Demonstrated ability as a technical expert in sterile processes, servicing and training.
• Demonstrated ability as a technical expert in formulation chemistry/troubleshooting day-to-day compounding issues.
• Demonstrated ability to evaluate, review and approve client formulation requests.
• Expertise to potentially assist in the development and implementation of Continuing Pharmacy Education activities; live and self-directed learnings.
• Expertise to potentially assist in the facilitation of Continuing Pharmacy Education activities.

Skills, knowledge and abilities:

• 5-10 years’ experience as a compounding pharmacist in a 503B Outsourcing Facility.
• 2-5 years’ teaching experience (e.g., preceptor, lecturer, facilitator, etc…) an asset.
• Active participant in National or State/Territory policy discussions, State Boards of Pharmacy advisory or committee member, etc. an asset.
• Demonstrated leadership abilities (e.g., committee chair, group leader, etc.)
• Demonstrated motivational assets (e.g., captivating, personable, approachable, etc.)
• Proven abilities to apply judgement, ethical practice and decision-making skills.

 We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.

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