POSITION TITLE: Formulation Chemist
JOB TYPE: Full-Time
The primary function of the Formulation Chemist is to perform various compounding related activities for a cGMP compliant Fill/Finish operation. Ability to apply standard practices, techniques, procedures and criteria, is necessary. Must be able to summarize findings and prepare reports, documents, records. Design and direct all aspects of formulation, specifically evaluation, development, scale-up, and manufacture of formulations for early and late stage clinical studies through validation batches to commercial manufacturing of drug products. The Formulation Chemist will ensure appropriate documentation, reports, SOPs, regulatory documents, and technology transfers of the formulation development are completed in a timely manner.
- Ensure that appropriate procedures and processes are utilized without unauthorized modifications.
- Review all specifications, criteria, etc., and ensure all specified materials, equipment and processes meet the required guidelines and/or industry standards.
- Ability to set-up, maintain and perform various bulk drug formulation related activities as required for a GMP compliant Fill/Finish operation.
- Develop SOP’s for all formulation related activities as required for a GMP compliant Fill/Finish operation.
- Assist in developing and writing a preventative maintenance program for all manufacturing related equipment and systems.
- Ability to initiate problem-solving and technical decision-making commensurate with the level of experience.
- Ability to trouble-shoot various equipment as required for the formulation and manufacturing operations.
- Perform various manufacturing duties according to the GMP guidelines and initiate appropriate documentation as required including all forms, logs, batch records, etc., according to the applicable SOP’s.
- Lead and perform all formulation activities for production as required.
- Ability to perform a technical evaluation of manufacturing related information and provide management with status reports including information required for decision-making purposes.
- Written and oral skills at a level commensurate for interaction with staff, vendors and clients as necessary.
- Familiarity with computers and software programs utilized for the generation of data and associated reports as related to manufacturing operations.
MSc / BS / BA with 5+ years experience in Bio-pharmaceutical products as sterile liquid and Lyophilized products.
- Bachelor’s (Preferred)
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .