Job Location:Nivagen Pharmaceuticals, Sacramento, CA
3900 Duckhorn Dr, Sacramento, CA 95834
About the Job: Title of the Position: Compounding Pharmacist (Full Time)
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.
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
Qualifications:
Education/Experience:- 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
Knowledge, Skills, and Abilities:- 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
- Experience with regulatory audits and inspections is a plus.
- Capable of maintaining confidentiality and handling sensitive information discreetly
Requirements:- 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
- Board certified Sterile Compounding pharmacist certification preferred.
- 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)
Benefits:- Pay range $180,000 - $180,000 per year
- Bonus Target eligibility determined by the President
- Performance-Based Incentive
- Benefits: Medical, Dental, and Vision coverage
- Paid time off plan
- 401 (k) savings plan
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, 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
