Responsible for assisting with and/or independently managing new development projects. Activities include producing batches (lab scale, pilot, and scale-up), packaging, and analytical testing. Writes scientific reports, batch records, specifications and development reports.
- Develops raw material specifications, batch records and product specifications for new development products.
- Tests and evaluates developed formulations using HPLC, viscometer, pH meter, particle size analyzer and in vitro release, etc.
- Conducts informal stability studies to evaluate the viability of the formulations.
- Performs scale-up of processes from pilot-plant to manufacturing.
- Provides technical support to other departments as needed.
- Routinely interacts with analytical development department.
- Professionally interacts with external customers and suppliers.
- Writes Standard Operating Procedures (SOPs), specifications, protocols for product development studies, batch records and developmental reports.
- Makes recommendations to improve processes and procedures within the PD Department.
- Occasionally contacts outside suppliers and contract labs.
- All other duties as assigned.
Knowledge, Skills & Abilities
Requires a working understanding of current Good Manufacturing Practices (cGMPs). Must have the ability to operate laboratory instruments, manufacturing and packaging equipment for the manufacture of liquids and semi-solid products. Knowledge of equipment, supplies, components, and technical areas that are utilized in the chemical laboratory, i.e. HPLC, UV-VIS, balance, FT-IR, GC, pH meter, viscometer, etc. Requires basic computer skills, including knowledge of Word, Excel, and Chromatography data systems. Demonstrated ability to write accurate technical documents independently and to successfully manage projects as needed. Must be organized and able to work independently as well as collaboratively in a team environment. The responsibilities of this position require effective communication skills (verbal, written, and listening).
Requires a Bachelor of Science degree in Chemistry or a closely related field or an equivalent combination of education and experience. Prefer three or more years experience in analytical chemistry with two or more years experience in a quality control or product development environment. Experienced and trained in the use of HPLC, GC, spectrophotometers, and other related lab equipment.
EO Employer M/F/Vets/Disabled