Formulation Scientist

I. Department /

Position Overview:

Product Development is responsible for new product development over the lifecycle of the project which could include benchtop/lab scale, demonstration/feasibility batches, registration/stability batches, and technical support of process validation batches. Additional responsibilities may include support of development/commercial product investigations, and technology transfers from other sites to the St. Petersburg, FL facility. The group is also responsible for Gap Assessments, Risk Assessments, and the implementation of process analytical technology (PAT) solutions and overall support of all aspects of product development.

II. Basic Function:
This position contributes significantly to the successful timely development of new pharmaceutical products utilizing Softgel Formulation/Process drug delivery systems and technologies by carrying out required pre-formulation, formulation and process activities.

III. Knowledge Requirements:

• Responsible for conducting pre-formulation, formulation preparation, testing and analysis work in the PD lab.

• Schedule and conduct lab work to ensure timely completion of the required activities.

• Perform solubility and compatibility studies.

• Prepare laboratory fill mixes, air fill capsules.

• Prepare gel swatches.

• Execute drying studies.

• Perform fill moisture, water activity, hardness, rheology, burst strength, impact/drop testing, disintegration, dissolution and/or other testing.

• Perform HPLC analysis. Prepare buffers, mobile phase and dissolution media.

• Provide experimental details and record the results in approved notebooks, batch records, reports and logbooks.

• Prepare samples for animal PK studies.

• Provide training to new or existing personnel.

• Required to read and execute departmental guidance and SOPs.

• Comply with Health, Safety and Environmental responsibilities for the position.

• Maintain current training records for required procedures.

• Perform other miscellaneous duties as required.

• May be required to work with highly potent compounds, hormones.

Education or Equivalent:

• BS in scientific field with 5 plus years’ experience in lab, 3 in GMP or

• MS in scientific field with 3 plus years’ experience in GMP lab

• Doctorate in scientific field with 1 plus years’ experience in lab

Knowledge/Skills Requirements:

• Strong scientific skills required.

• Must have accurate and legible documentation skills.

• Working knowledge and application of scientific principles and techniques. Exposure to computer software associated with word processing and spreadsheets required.

• Effective communication, documentation and writing skills required

• Attention to detail and high-level of organizational skills required.

• Experience with testing and analytical equipment.

• Required to use laboratory equipment, including HPLC.

• Required to use business-related software programs, including but not limited to Microsoft Word, Excel, PowerPoint, and Teams, as well as Empower, Chem Station, and other software as it relates to specific job duties.