The formulation scientist is responsible for designing and developing appropriate formulation developmental studies for various pharmaceutical dosage forms, with an emphasis on parenteral drug delivery. The position requires ownership and accountability to the assigned tasks in a fast-paced environment, meeting the deliverables and timelines of the various projects. The scientist will be given opportunities to think independently and come up with rational design of experiments and creative solutions to trouble shoot the product and process developmental challenges. In this process, the formulation scientist independently designs, plans, performs, reports, and interpret the results of scientific experiments in a timely manner. The position requires superior leadership behaviors of Alcami core competencies and non-negotiables, as well as expertise in functional competencies including thorough understanding of preformulation and pharmaceutical product development, cGMPs and regulatory requirements for pharmaceuticals.
- Creates formulation development plans and executes well designed experiments to lead the product development.
- Utilizes appropriate tools (risk analysis, statistical design of experiments, preformulation characterization, model building and statistical analysis) for successful product development.
- Writes and executes protocols to prepare formulations for testing and characterization, methods development and technological transfer.
- Records and reports study results in compliance with approved standard operating procedures (SOPs) and as per cGMP requirements.
- Maintains working knowledge of instrumentation, equipment and scientific methodologies necessary to perform assigned tasks.
- Reports and presents scientific/project related results internally and to external clients, on a timely manner.
- Writes, test procedures, specifications, summary reports and product development reports in compliance with current FDA requirements.
- Works closely with other support groups such as analytical R&D and QA groups in supporting the deviations and investigations.
- Interacts with clients and participate in regulatory agency and/or client audits.
- Reviews own work and conducts peer review.
- Ensures timely completion and compliance with SOPs and all other relevant company training documentation requirements.
- Master’s degree in Pharmaceutical Sciences with 2+ years of experience or Ph.D. in Pharmaceutics.
TriPharm Services, Inc. is an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. TriPharm complies with all employment eligibility verification requirements of the Immigration and Nationality Act, and all must have the authorization to work in the U.S.