POSITION TITLE: Formulation Chemist
REPORT TO: Associate Director of Formulation / Project Management
Performs various compounding related activities for a cGMP compliant Fill/Finish operation. Key contributor to parenteral, aseptic processing operations, as it relates to drug product formulation and manufacturing. Must be able to summarize findings and assist in the preparation of reports, documents, records, etc. of assigned tasks.
- Lead and perform all formulation activities for production as required.
- 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.
- Function as a primary technical resource for drug product manufacturing, formulation/compounding, filling processes and inspections.
- 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 SOPs.
- 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 SOPs for all formulation related activities as required for a GMP compliant Fill/Finish operation.
- Ensure appropriate documentation, reports, batch records, protocols, SOPs, and technology transfers for formulation development are completed in a timely manner.
- Ensure that appropriate procedures and processes are utilized without unauthorized modifications.
- Assess process performance by monitoring and analyzing process/product.
- Identify process issues and plan / implement process improvements.
- 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.
- 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.
- Bachelor’s or master’s Degree in pharmacy, chemistry, engineering, or related fields.
- 3-5 years’ experience in pharmaceutical parenteral manufacturing (aseptic processing/sterile manufacturing).
- Working understanding of aseptic manufacturing and sterile drug product development.
- Knowledge of cGMPs and other regulatory requirements governing pharmaceutical manufacturing.
- Understanding of manufacturing equipment and knowledge of GMPs.
- Previous experience with tech transfers for aseptic manufacturing procedures.
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .