Production Supervising Pharmacist

Pentec Health   •  

Boothwyn, PA

Not Specified years

Posted 240 days ago

This job is no longer available.


Provide operational, supervisory, and leadership to the production team members within an FDA registered outsourcing facility.  Possesses knowledge of USP <797> and cGMP regulations and has experience with production of compounded sterile preparations (CSPs) ensuring compliance with all federal and state regulatory requirements for an outsourcing facility. 


Essential Duties & Responsibilities:

  • Directly supervise all personnel and functions involved in the production of CSP and manages the day to day cleanroom activity, as well as, providing technical support to production team members. 

·         Oversee and participate in the operation of the production areas specific to compounding/cleanroom facility, sterile intravenous preparations, and outsourcing operations, including all compliance activities under the Quality program. 

  • Works closely with Quality and Operations to ensure all production efforts are in compliance with cGMP and trains staff accordingly.

·         Participates in the selection, training, professional growth and development, and supervision, inclusive of performance evaluations in accordance with HR policy for all directly reporting production personnel. 

  • Assists in the development, training and adherence to all Pentec policies and procedures in compliance with USP <797> and cGMP expectations and assures the production department is performing consistently within all organization standard operating procedures (SOPs).

·         Works within a team environment to implement and maintain a distribution and compounding model that ensures operational efficiencies and automation in place to support new business and promote maximum safety and service to our customers.

·         Strong focus for training of staff, attention to detail and documentation – both for compliance and regulatory – for facility environment (cleaning, disinfection and maintenance) and personnel.  Coordinates the pharmacy production team utilizing existing and potentially new information systems, including automation and/or robotics, to ensure appropriate flow of information from the production area, including the change parts washroom and labeling responsibilities to other departments within the outsourcing facility.

·         Assures that all CSPs are distributed in accordance with federal, state and local laws in accordance to standards of practice including all regulatory and accreditation requirements.

·         Implement and maintain systems to ensure the safe, accurate, aseptic preparation of all CSPs and processes – this includes participation in the IOQ and PQ of any piece of equipment, in conjunction with the validation team. 

·         Implements work schedules, assignments, and benchmarks to maximize operational efficiency and staff productivity, while minimizing overtime.

·         Interacts effectively with Operations, Distribution, Quality and Purchasing team members, company leaders, and Human Resource staff.

·         Actively involved in the evaluation and selection of new products and equipment to increase staff productivity and ensure quality and safety in clean room compounding practices.                                                                                                                                                              

·         Serves as a company representative as requested in the clinical and business communities.

·         Assists in Root Cause Analysis in regard to test failures and process failures.

·         Contributes to the enhancement of teaching protocols and manuals for the education and development of pharmacy staff.

·         Applies for, completes all required testing, and obtains pharmacy licensure in other states as business needs arise.

·         Performs other duties, special projects as assigned.

Authority & Accountability

  • Member of the 503B Leadership Team.
  • Responsible for managing and leading the production staff in an FDA registered outsourcing facility.


Skills, Competencies and Experience:



·         Strong leadership skills and experience;  supervisory or staff management abilities

·         Strong tactical implementation skills

·         Excellent oral and written communication skills


  • Strong pharmaceutical background
  • cGMP experience in a related industry

Education, Certifications, Trainings:



·         Supervisory experience in sterile compounding within a pharmacy or cGMP pharmaceutical environment. Licensure in good standing to practice pharmacy in the Commonwealth of Pennsylvania

·         BS in Pharmacy or Pharm. D. from an accredited school of Pharmacy


·         Advanced degree

·         Six Sigma Certification



·         Proficiency in the following: MS Word and Excel


·         Proficiency in Microsoft Dynamic AX ERP or similar software

·         Knowledge and experience with pharmacy automation, intravenous compounders and/or robotics

Req # 2251