This position will focus on process and formulation development of peptide drug product. The successful candidate will work closely with the Process Development, manufacturing and Quality Control teams under the supervision of formulation group leader. The successful candidate will provide formulation and process development, optimization and scale-up support for generic peptide drug product development, and carry out other tasks assigned.
Specific Duties and Responsibilities:
- Planning and carrying out formulation development work under supervision of formulation group leader.
- Under the general guidance, independently carry out analysis of the raw materials, APis, excipients and drug products with all needed methods;
- Independently follow the study guide, carry out studies to collect data and report results to group leader and upper management team.
- Creating and revising technical reports, maintaining appropriate lab records; Initiating and generating ideas based on reading and research.
- Assist in devising new formulation, or refining existing ones and transferring to partner for drug product formulation;
- Optimization of the process by DOE and QbD methods and scaling up of the formulation studies to pilot / production scale.
- Proposing improvement based on the formulation studies;
- Maintaining and modification of the related instrument /equipment. Responsible with the hardware development/acquisition needed for formulation and PD work.
- Working with different dept. of the company at various stages of drug product development;
- Other duties assigned as needed.
Responsibilities may change based on business demand or strategy and/or the organizational needs of the company.
- Candidate must have 1-2 years of industrial experience with formulation development. Must understand the routine analytical methods for peptide drug product of different dosage forms.
- The ideal candidate is expected to have in-depth understanding of protein /peptide chemistry and have a bachelor / master degree in chemistry, pharmaceuticals, formulation, biochemistry or relevant areas.
- Candidate is expected to be proficient with HPLC operation, instrumentation and data collection.
- Ideal candidate is expected to have DOE and/or QbD experience in formulation development.
- Candidate is expected to manage multiple projects at the same time.
- Must be able to work overtime in the evening or weekend when needed occasionally.
- Education and prior experience requirement: candidate is expected to have 2 years’ experience with a bachelor degree or 1-2 years’ experience with a master degree in chemistry, pharmaceutical science, chemical engineering et al related area.
Candidate must meet company employment requirement such as drug screen and probation time.