POSITION TITLE: Formulation / Compounding Technician
REPORT TO: Associate Director of Formulation & Project Management
Under general supervision, perform the formulation / compounding of sterile injectable pharmaceutical products according to Good Manufacturing Practices (cGMPs) utilizing Standard Operating Procedures (SOPs) in the Clean Room. Must be able to summarize findings and prepare or assist in the preparation of reports, documents, records, etc., for assigned tasks.
- Familiar with related cGMP procedures and requirements, as directly related to the position.
- Performs formulation/compounding of biopharmaceutical bulk solutions for liquid and lyophilized products.
- Follow Standard Operating Procedures and Batch Record processes.
- Learn and generate production batch records.
- Ability to set-up, maintain and perform duties and various manufacturing related activities as required for a GMP compliant Fill/Finish operation according to the applicable guidelines, i.e., FDA, GMP, ICH, etc.
- Record laboratory results and prepare all accompanying documentation.
- Maintain laboratory and manufacturing quality control through cGMP.
- Perform sanitization of clean rooms, and sterilization of equipment.
- Work independently as well as in a team atmosphere. Interaction with Contract Clients.
- Perform other related duties and responsibilities as assigned.
- Knowledge of current Good Manufacturing Practices (cGMP) for drug substance operation.
- High School Diploma or GED with 5-7 years required in formulation / compounding or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
- Demonstrate basic math, computer and record keeping skills required.
- Demonstrated ability to follow and document activities in written procedures and/or logbooks.
- Close vision, color vision, peripheral vision, depth perception, ability to focus.
- Must wear a lab coat and other safety attire.
- Work under direct supervision and follow clearly described procedures.
- Good organizational and record keeping skills.
- Attention to detail.
- Strong verbal, written and interpersonal communication skills.
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .