Pharmacist in Charge

Hikma Pharmaceuticals • South Brunswick Township, NJ

282d

About The Position

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. 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.

Requirements

• 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.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree