Job Purpose:

Seeking a well-qualified pharmacist for a 503B outsourcing facility located in Central New Jersey.  New Jersey licensure is required, as well as the ability to obtain multiple state licenses.  Previous experience with 503B outsourcing, USP 797, as a Pharmacist-In-Charge (PIC) and/or hospital IV compounding needs would be an advantage.  The ideal candidate would be a self-starter with an entrepreneurial mindset who will join a team of like-minded individuals.

Position Summary:

• As part of supervising the Compounding activities, the Pharmacist-In-Charge is responsible for ensuring compliance with USP 797, FDA, PCAB, BOP rules and regulations, cGMP and all FDA requirements.
• Ensure updated validity of pharmacist license in relevant states.
• Be responsible for monitoring and communicating regulations of all state and federal regulatory agencies.
• Assist in new 503B product development and ensure compliance with all company procedures and federal and state laws, rules, and regulations.
• Working collaboratively with Supply Chain
• Managing the “Beyond-Use-Date” stock
• Create a culture of continuous improvement and provide coaching and mentorship.

Primary Accountabilities:

NOTE: The primary accountabilities below describe the general content of and requirements of this position. This is not an exhaustive statement of duties.

• Managing the FDA Drug shortage list to ensure that CSP follow the 503B Guidance.
• Provide technical support in the interactions with and applications to state and federal regulatory bodies.
• Provide expertise and testimony of compounding operations as needed during regulatory inspections.
• Assist in inspections, accreditations and other regulatory requirements.
• Assist in Identifying and development of new products.
• Participate in product trend analysis.
• Assist in investigations related to non-conformances of CSP.
• Assist in the implementation of corrective and preventive action plans.
• Assist in the drafting and review of protocols designed for product development and/or validation.
• Assist in writing, review and update of batch records, SOPs, and other cGMP documents

Knowledge, Skills & Abilities:

• Bachelor of Pharmacy or PharmD required.
• Licensed as a registered pharmacist in the State of New Jersey or eligible for licensure as a registered pharmacist in the State of New Jersey.  If eligible for licensure as a registered pharmacist in the State of New Jersey, the successful applicant will be required to obtain such licensure within six (6) months of their start date, with such a requirement being a condition of their continued employment.  Additional licensure/eligibility for licensure as a registered pharmacist with the following states is preferred: AL, AK, FL, ID, KS, MI, NV, NY, OH, OK, and VA.

• 503B Compounding experience and USP 797 knowledge and experience required.

• FDA and State BOP audits experience preferred.
• Researching compounded formulas to ensure safety and proper CSP.
• Workflow management – Knowledge of sterile compounding practices.
• Knowledge of compounding tools and equipment.
• Knowledge of associated standards and operating procedures in relation to cGMP.
• Knowledge of 503B practices, aseptic processes (USP 797) (gowning, garbing, gloving etc.)
• Specific expertise, skills and knowledge within research, development, and sterile compounding gained through education and experience.
• Ability to communicate technical information to non-technical personnel.
• A broad perspective to organize objectives, both long-term and day-to-day activities.
• The ability to change direction and focus to meet shifting organizational and business demands.
• The ability to set clear targets and use performance measures to assess risk and opportunities.
• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage self, demonstrate integrity, be productive under pressure, and achieve development goals.
• The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.
• The ability to manage multiple resources and be accurate and current with data and information.
• The ability to create new products and processes that add value to the Business by applying creative and analytical approaches.
• Accepts feedback, asks questions, and delegates
• Builds and fosters professional relationships

Other Duties:

Please note this job description does not cover or contain a comprehensive listing of all activities, duties or responsibilities that are required of the employee for this position Duties, responsibilities and activities may change at any time, with or without notice.