Compounding Pharmacist

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

Job Duties Overview:

The Pharmacist is responsible for the daily operations and activities of the assigned Pharmacy area. This position ensures that the pharmacy area meets all regulatory and compliance requirements and adheres to best practice standards. The Pharmacist is responsible for implementation of new policies and procedures. This position participates in planning and policy making for the assigned area under the direction of our Director of Operations.

Responsibilities:

• Provides oversight and direction to the employees in the pharmacy in accordance with CSBio policies and procedures. Coaches and develops staff including training new pharmacy team members in the pharmacy. Delegates responsibility and expects accountability from pharmacy team members. Fosters a spirit of teamwork and unity among pharmacy members.
• Ensures the pharmacy is ever-ready for inspections and audits by the state or by the Joint Commission and/or any accreditation board designated for the pharmacy. Assists in training of Pharmacy personnel.
• Assists in personnel planning. Determines the qualifications and competence departmental staff who provide patient care services; documents initial and ongoing competence of staff.
• Develops and maintains an effective system of information, records and reports for assigned department(s) utilizing appropriate manual or electronic systems. Effectively maintains appropriate quality improvement and control programs in response to staff and patient feedback, internal standards of care and external requirements.
• Ensures proper control and record keeping for Controlled Substances stored in and distributed by the Pharmacy; routinely reviews records to assure accountability and conformity with legal requirements and immediately reports any discrepancies and deviations from established policies and procedures to the Director of Operations and to the pharmacy compliance team. Ensures that the pharmacy meets all Board of Pharmacy and DEA requirements and is ever-ready for a DEA audit/BOP visit
• Ensures there are adequate ongoing educational programs and training opportunities for all staff in area of responsibility, including orientation of new employees and relevant in-service education sessions. Participates in the development, implementation and evaluation of Departmental Policies and Procedures. Performs duties of Clinical Pharmacist and staffs the pharmacy on a regular basis.
• Shares on call responsibilities
• Assists with department activities including the annual inventory, biennial inventory of controlled meds
• Ensures compliance with the 340B program and optimizes drug expenditures

Competencies:

• Ability to apply judgment and make informed decisions
• Ability to conduct analysis and formulate conclusions
• Ability to effectively prioritize work and meet deadlines in a fast-paced environment
• Ability to foster effective working relationships and build consensus
• Ability to plan, organize, prioritize, work independently and meet deadlines
• Knowledge of computer systems and software used in functional area
• Knowledge of influence of patient's age, sex, concomitant disease states, concurrent drug therapy, foods and diagnostic procedures on drug activity and disposition
• Knowledge of local, state and federal regulatory requirements related to areas of functional responsibility
• Knowledge of Medical terminology and abbreviations; pharmacology and pharmacological nomenclature; medical therapeutics, pharmacokinetics, and disease states
• Knowledge of methods and procedures involved in proper handling and storing of pharmaceutical supplies
• Knowledge of proper environmental monitoring and cleaning
• Knowledge of physiology, anatomy, pathology, chemistry and mathematics as they relate to pharmacy practice
• Knowledge of prescription and non-prescription drugs and drug products and their indications, efficacy, dosage, mechanisms of action; fate and disposition (if known), major contraindications and potential side effects

Requirements

Minimum Qualifications

• Be fully trained in non-aseptic and aseptic compounding.
• Have at least twp year experience working in a compounding pharmacy, outsourcing establishment or other extemporaneous compounding operation producing drugs for human use.

Professional

• PhD., B.S. or Pharm. D. degree from accredited school of pharmacy
• Must be currently licensed and in good standing with the Local State Board of Pharmacy.
• Compliance with continuing education mandates
• One to two years pharmacy leadership experience preferred
• Participation in in-facility and out-of-facility training activities including but not limited to:
• Aseptic training

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee’s family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities