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