​​About the Role:

The Compounding Pharmacist will be responsible for the oversight and growth of 503B outsourcing facility compounding according to the standards and compliance for MedisourceRx. Will meet the manufacturing and company goals for successful operations of a fully compliant department ensuring facility, equipment, safety, product quality, manufacturing efficiency, and quality systems are in compliance with regulatory standards. This position reports to the head pharmacist.

You Will:

• SME for good Aseptic practices and ensure precautions for sterile compounding.
• Monitor day to day operation in the cleanroom and ensure smooth operations.
• Help with mixing and filling as needed, ability to work with automated machines and devices and troubleshoot as needed.
• Must have familiarity and experience with all necessary pharmacy and compounding equipment.
• Help head compounding pharmacist with training and competencies for cleanroom technicians.
• Run R&D and production batches with minimum supervision of the head pharmacist.
• Perform Mixing & filling supplies verifications.
• Work closely with the tech lead , operation manager and other department leads to meet product output.
• Complete Batch records & review production sections.
• Clinical knowledge to answer technical questions about the drugs we have at MedisourceRx. (Drug/ chemical information, IV compatibility, osmolarity calculations, etc.).
• Controlled substance records knowledge and inventory management.
• Work with QA for investigations related to production.
• Maintain team’s cGMP compliance in the cleanroom.
• Clinical projects as assigned by the supervisor.
• Assist in Visual Inspection and Labeling as required to support production.
• Other duties as assigned by the head compounding pharmacist.
• Draft SOPs revisions, process validation, draft a master compounding record, etc

You Have:

• 2+ years of pharmacist experience, at least 1+ in a compounding pharmacy or relevant compounding experience.
• Bachelor’s degree in Pharmacy. (Pharm D is preferred)
• Active Pharmacist License in California.
• Controlled substance records knowledge and inventory management.
• Effective knowledge of state and federal pharmacy laws, rules and regulations related to the practice of pharmacy.
• Ability to work flexible shift times.
• Proficiency in Windows-based computer systems.
• Must be able to undergo respirator fit testing
• Must have the ability to work in a fast-paced environment.
• Must be capable of working with small, delicate pieces of expensive machinery to complete appropriate dosage forms in a timely manner.
• Must be a knowledgeable and empathetic leader to the technician team.
• Must be able to work cross-functionally with remote teams.
• Pharmacists will work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking; for prolonged periods of time. Must be able to stand for long periods of time.
• Must be able to wear required compounding safety equipment for long periods of time when required.
• Follow all state and pharmacy regulations and rules as designated by the California State of Pharmacy and the Food and Drug Administration (FDA).
• Maintain a clean and sanitary work environment as mandated by the FDA’s rules and regulations.
• Dispense medications and ensure accurate interpretation, labeling, and product selection of prescriptions.
• Complete pharmacy operational requirements by organizing and directing technicians’ workflow, verifying their preparation and labeling of pharmaceuticals, and verifying order entries, charges, and inspections.
• Supervise the work results of support personnel.
• Protect patients and technicians by adhering to infection-control protocols.

Required:

• Deep understanding and experience in USP <797> & USP <800> guidelines, as well as manual aseptic manipulations.
• California Pharmacist License in good standing.
• Knowledge and experience in cGMP and FDA 21 CFR parts 210 and 211.
• Experience participating in a Manufacturing Unit in an FDA registered facility that includes cGMP compliance and sterile product preparation of pharmaceuticals OR experience as a pharmacist in a pharmacy that prepares sterile parenteral compounds.
• Work in controlled environments and wear personal protective equipment as necessary.

Preferred:

• Knowledge within the areas of quality control and process validation.
• Familiarity and understanding of manufacturing methods related to quality control and sterilization assurance.
• Experience participating in a supply chain management in FDA approved GMP facility that includes cGMP compliance and sterile product preparation for pharmaceuticals.
• Previous 503B pharmacist experience.

Our Benefits (there are more but here are some highlights):

• Competitive salary & comprehensive health benefits including medical, dental & vision

Conditions of Employment:

• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.