SUMMARY
The incumbent will work in the development of oral solid dosage pharmaceutical products. Conducting formulation and process development, manufacturing clinical trial supplies, and supporting commercial product manufacturing when required. The incumbent will support implementation for the continuous process improvement efforts within the customers business segment in the area of technology transfer and process scale up. Assist customers in evaluating technical needs and advise on equipment selection. The individual may also participate in continuous process improvement projects and support departmental initiatives, as well as evaluate new technologies to expand our service offering. There is an expectation of direct hands-on laboratory work and/or supervision of one or more direct reports and mentoring/training of other colleagues as needed.
RESPONSIBILITIES
- Conduct physical and chemical property assessment (solubility, stability, particle size, etc.) of candidate compounds
- Conduct formulation and process development for oral solid dosage forms of new chemical entities and/or generic products.
- Perform lab and manufacturing experiment using key manufacturing equipment, including but not limited to, high shear granulator, fluid bed granulator/dryer/coater, blender, tableting machine, and film coating equipment.
- Conduct laboratory analysis on raw materials, in-process, and product formulations using key analytical apparatus, including but not limited to, scanning electron microscope, light microscope, laser particle size analyzer.
- Communicate results internally and externally through verbal and written updates and formal reports as necessary. Organize meetings and monitor all customer interactions independently. Participate in and lead cross-functional project teams to meet company and/or customer goals.
- Creates and/or revises new department-wide and site-wide procedures and company SOPs. Stay abreast of current scientific technologies to maintain the state of the art nature of CCU and will evaluate new technologies to expand our technical service offering.
- Proactively communicate strategy to customers and write and review new proposals and change orders, as appropriate.
- Support the business aspects of the position by taking responsibility for execution and communication of all work under their supervision.
- Develop junior personnel in both Technical Service and Operations departments for project support. Participate in new project opportunities by generating scientific expert content, hosting new customer visits or teleconferences, and attending conferences or customer visits to generate new leads. Responsible for maintaining GLP/GMP laboratory environment and maintaining a safe, clean laboratory.
- Execute laboratory work plan/schedule developed with input from supervisor or senior team member. Draft technical documents such as batch records, technical reports and protocols with supervisor guidance.
- Perform parallel review of manufacturing documentation and may become qualified to perform technical review of documents for accuracy, thoroughness and regulatory compliance.
- Train others on basic laboratory and manufacturing techniques.
- Assist in the execution of efficiency improvement project with guidance.
- Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs.
- Performs physical testing as needed; bulk/tap density, flow analysis (Johanson and FT4) and sieve analysis.
- Executes procedures or methods of moderate complexity with high quality.
- Support novel manufacturing technology assessment to expand and improve CCU's technical capability according to the mid/long term investment plan.
- Perform bench marking and risk assessment of new manufacturing technologies working with vendors and prepare information summary for discussions.
- Reviewing manufacturing information (formulation compositions, processes, documentation) from a customer and develop/implement the manufacturing procedure into manufacturing area. Work with customer and CCU operation group members to conduct tech-transfer batches under
- Provide a manufacturing procedure to the Operation Group for commercial production.
- Work with CCU operation group members to conduct internal technical transfer batches.
- Prepare technical documents for execution of study protocol and study reports as required.
- Prepare and revise GMP documentation to manufacturing batch records, SOPs, etc.
QUALIFICATIONS
- Must be fully bilingual (read, speak, write) in Japanese
- Working knowledge of the theories and manufacturing processes associated with the experimental manufacture of oral solid drug products specifically and pharmaceutical products in general.
- Bachelors degree in chemistry, Biology, Chemical Engineering, or related field.
- At least 2 years experience in pharmaceutical process/product development environment.
- Familiar with technologies including Fluid Beds, High Shear Granulators, Tablet Presses, Tablet Coaters, Blenders, Mills, etc.
- Mechanical knowledge and hands on experience relating to fluid bed processor, granular, tablet press, encapsulation, and coating equipment.
- Formulation and process development for oral dosage forms.
- Technical transfer and scale up experience.
- NDA/ANDA filing experience including design space and DOE.
- Ability to handle difficult situations produced by time constraints and customer demands, etc.
- Possess good knowledge of cGMPs and safety practices.
- Possess good interpersonal skills.
- Good verbal and written communication skills, computer skills in word processing, spreadsheets and some technical software.