Nature and Scope
Responsible for formulation and process development activities associated with parenteral drug product development following Quality by Design (QbD) principal. Participates in manufacturing process scale-up and technology transfer. Supports trouble shooting of manufacturing issues, ANDA submission and regulatory response to FDA deficiency. Responsible for training of laboratory personnel in areas of expertise.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- Conduct literature search and pre-formulation studies on new generic products.
- Design and execute parenteral formulation studies in accordance with company procedures and appropriate FDA/ICH guidance.
- Design and execute laboratory experiments to study material compatibility and evaluate sterilization options.
- Develop scalable manufacturing process for parenteral drug products.
- Draft raw material specifications.
- Write R & D study and product development reports and generate documents in support of regulatory submission.
- Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health and safety requirements.
- Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- PhD with experience 5 years progressive work experience in pharmaceutical drug product development, or master’s degree plus 10 years progressive work experience in pharmaceutical drug product development required.
- Broad knowledge of formulation development following QbD principal, formulation characterization, process development, and scale up of sterile injectable products is essential.
- Experience in development of suspension and freeze dried products is a plus.
- Hands on skills in analytical instrumentals such as HPLC, particle sizer and Karl-Fischer titrator are a plus.
- Knowledge of pharmaceutical product lifecycle management is a plus.
- Excellent organizational, interpersonal and communication skills are required.
- Proficiency in Microsoft Office Word and Excel is required.
Physical Environment and Requirements
- Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
- Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
- Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
- Position requires working in the laboratory as well as sitting.
