Compounding Pharmacist

Nivagen Pharmaceuticals•Sacramento, CA

34d•Onsite

About The Position

The Compounding Pharmacist at Nivagen will be responsible for leading the 503B outsourcing facility, ensuring adherence to compounding standards and regulatory compliance. This role is pivotal in meeting manufacturing and company goals by overseeing the successful operations of a fully compliant department. Key responsibilities include maintaining facility and equipment standards, ensuring safety, upholding product quality, optimizing manufacturing efficiency, and managing quality systems in line with regulatory requirements. The Compounding Pharmacist will report directly to the CEO and/or the Production Manager.

Requirements

Doctor of Pharmacy (Pharm.D.) degree from an accredited institution
A minimum of two to three years of experience in a compounding pharmacy or a 503B outsourcing facility, or equivalent experience in related fields, is required
Understanding and experience in USP 797 guidelines and manual aseptic manipulations
Strong leadership skills with the ability to manage and mentor a team
Excellent communication and organizational skills
Capable of maintaining confidentiality and handling sensitive information discreetly
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
Knowledge within the areas of quality control and process validation
Familiarity and understanding of manufacturing methods related to quality control and quality assurance
Experience participating in a supply chain management in an FDA approved GMP facility that includes cGMP compliance and sterile product preparation for pharmaceuticals
Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)
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, a 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

Nice To Haves

Experience with regulatory audits and inspections is a plus.
Board certified Sterile Compounding pharmacist certification preferred.

Responsibilities

Work with Production Lead to achieve daily compounding output goals
Design weekly production schedule with Production Lead
Assign technician roles for the week (i.e. Mixer, Filler, Assistant, etc.)
Direct techs to a particular task to maintain production flow
Complete Batch records
Supervise compounding activities
Perform Mixer, Filler, Assistant, or any technician duties as needed
Check customer orders for accuracy
Clinical customer service (Drug info, IV compatibility, osmolarity calculations etc.)
Controlled substance records management
QA reports/investigations as assigned: MOCA, CAPA, MRDD, Complaints
Maintain team’s cGMP compliance at MSRX
Participate in regulatory audits
Draft SOPS revisions, process validation, draft a master compounding record, Process Validation etc
Other duties as assigned by management or CEO and production manager