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Pharmacist in Charge, 503B Facility

Dallas, Texas (On-Site)

This position will focus on the new pharmaceutical factory in the Deep Ellum area of Dallas, TX. The Pharmacist-In-Charge (PIC) will assist managing and overseeing several aspects of work performed in a 503B Outsourcing Facility, including but not limited to its production personnel, and compounding activities. The 22,000 sq. ft. facility will focus on sterile fill finish products that are currently on the FDA drug shortages list and pediatric chemotherapy. This role will have the direct support of the Director of Manufacturing Operations and the Director of Quality and Safety.

Duties and Responsibilities:

  • Develop a system to ensure that all pharmacy personnel responsible for compounding and/or supervising the compounding of sterile preparations within the pharmacy receive appropriate education and training and competency evaluation
  • Ensure that all personnel involved in compounding sterile preparations obtain continuing education appropriate for the type of compounding done by the personnel
  • Oversee and develop a system that ensures the appropriate procurement of drugs and devices and storage of all pharmaceutical materials including pharmaceuticals, components used in the compounding of sterile preparations, and drug delivery devices
  • Responsible for ensuring the proper maintenance, cleanliness, and use of all equipment used in the compounding process
  • Responsible for ensuring that compounded sterile preparations are accurately identified, measured, diluted, and mixed and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed
  • Inspect and approve all components, drug preparation containers, closures, labeling, and any other materials involved in the compounding process
  • Review all compounding records for accuracy and conduct periodic in-process checks as defined in the pharmacy's policy and procedures
  • Leads compliance with all laws and regulations governing the FDA 503B Outsourcing Facility, cGMPs, along with internal policies and procedures within the facility. Knowledge of USP <797>.
  • Plans and maintains product manufacturing schedule
  • Responsible for the performance to the Continuous Quality Assessment and Improvement Program and support activities with Quality team
  • Collects and analyzes data
  • Maintains accurate records and documentation
  • Makes pharmaceutical calculations
  • Understands and complies with laws, regulations and policies governing an 503B outsourcing facility and cGMPs
  • Ensures Local, State, and Federal regulatory compliance
  • Develops and maintains strong customer service relationships
  • Provides financial and operational reporting to management
  • Functions as a Staff Pharmacist when needed

Education and/or Training:

  • BS/Pharm.D. Degree from an ACPE-accredited school of pharmacy; BCSCP highly preferred; BCOP preferred.
  • Valid and current licensure as a pharmacist from the State Board of Pharmacy in Texas; multiple state pharmacist licenses highly preferred including but not limited to Alabama, Arkansas, California, Kansas, Kentucky, Nevada and New York.
  • Five - Seven years of experience as a licensed pharmacist, included supervisory or management experience.
  • Applicable industry/professional certification required.
  • Previous IV admixture experience; pediatric chemotherapy experience a plus.
  • Knowledge of inventory control.
  • Willingness to comply with state and federal laws, regulations, standard operating procedures pertaining to the 503B Outsourcing Facility, cGMPs, USP <797> and all internal policies and procedures; 503A sterile compounding a plus.
  • Knowledge of record keeping requirements and procedures.
  • Excellent written and verbal communication skills.
  • Regular and predictable attendance.
  • Ability to work non-standard schedule as needed, On-call hours as needed

Work Experience:

  • Extensive knowledge of IV products in manufacturer setting and/or 503B setting, including cGMPs, USP <797>, and policies and procedures.
  • IV compounding utilizing aseptic techniques.
  • Basic accounting and budget awareness.
  • Proven managerial experiences.
  • Knowledge of general administrative practices.
  • May periodically assist in orienting, training, and/or reviewing the work of peers.
  • Judgement is required in resolving complex problems based on experience.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers; frequent contact with external contractors/vendors.
  • Knowledge of management principles and supervisory practices.
  • Plan, organize, and manage Pharmacy Operations.
  • Hire, train, supervise, motivate and evaluate staff.
  • Computer literary in windows and mac environments and computer systems.
  • Establish and maintain effective relationships with staff and senior management and quality team.
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