COMPANY: Champions Oncology, Inc.
TITLE AND CLASSIFICATION: Formulations Supervisor
REPORTING LOCATION: Baltimore and Gaithersburg, MD
REPORTS TO: Director, Global Laboratory Operations
Manage the daily operation, schedule and function of the formulations department, which provides all chemistry and formulation support for in vivo research. Develop preparation methods if not provided. Document all work for a regulatory environment.
DUTIES AND RESPONSIBILITIES:
- Manage the day-to-day formulations/drug compounding operations of the laboratory; arrange for adequate staffing at all times; monitor daily operations to ensure all SOP’s are being followed.
- Understand and ensure staff follow all SOP’s and Quality Assurance Standards.
- Create, maintain, and review formulations related SOPs to ensure they reflect current work practices.
- Assist with the audits for regulatory and sponsor audits of the facility and studies.
- Draft, edit, modify and verify preparation procedures according to protocol / published research/ Project Lead and/or Client instruction.
- Assist with the costing of consumable supplies used for studies.
- Assist with ordering drugs, reagents, and lab supplies.
- Recommend drug/dosing regimens in collaboration with the project management team based on published and/or historical data.
- Monitor test materials accountability and re-supply, maintain facilities for regulatory compliance.
- Maintain a clean and safe work environment.
- Maintain test material inventory, lot information, COA, and SDS for test agents and reagents.
- Supervise Formulation Technicians within the lab.
- Ensure the proper training and competency of Formulations staff.
- Provide input into hiring and firing decisions; conduct performance appraisals and provide counseling when needed.
- Involved in quality investigations and resolution and implementation of appropriate corrective action, when necessary.
- Assist with other tasks/duties as need in a small company environment.
KNOWLEDGE, SKILLS, AND ABILITIES
- Experience with dose formulations and drug compounding in preclinical in vivo pharmacology studies: efficacy studies, MTD, MOA, and PK/PD studies. Experience with oncology studies preferred.
- Strong Chemistry and/or Biology knowledge is a must.
- Demonstrated supervisory and mentoring skills.
- The ability to:
- provide expertise and guidance for the company’s formulations needs.
- perform dose calculations and unit conversions.
- observe safety and security procedures
- work with precision in a regulated laboratory environment.
- be detail oriented, with the ability to see the big picture.i
- interact and collaborate effectively at all levels of the organization.
EDUCATION AND EXPERIENCE
- BS degree in Chemistry, Biochemistry or related field.
- Knowledge and understanding of the working of a contract research organization.
- Minimum 4 years of experience in a CRO environment. Advancement to supervisor and/or manager preferred.
- Experience in project management.
- Hospital and/or compounding pharmacy experience a plus.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Must be able to sit and use hands to finger, handle and feel.
- Must be able to lift and move packages weighing up to 50 pounds.
- Must be able to sit for long periods of time using a computer in a typical office environment in a multi-level facility.
- Some activities require repetitive motion and reaching, pulling or pushing.
- In carrying out the duties of the job there will be frequent exposure to fumes and chemical hazards.
This job description may be changed to include new responsibilities and tasks or change existing ones as management deems necessary.