Japanese pharmaceutical R&D company in NJ seeks Japanese Scientist to work in the development of pharmaceutical products that includes but not limited to Oral solids, Liquids, Powder for suspension.. 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 customer’s business segment in 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. The job involves working on the bench development, scale up and technology transfer of the dosage forms mentioned above.
Title: Scientist
Department: Pharmaceutical R&D
Location: Cranbury, NJ
Position Function: Formulation & Process Development.
Salar range: 100-130K plus full benefits package. Will sponsor visa if necessary.
RESPONSIBILITIES:
• Conduct formulation and process development for oral solid dosage forms of new chemical entities 505(b)2, and 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.
• 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.
• Performs secondary review of other colleagues’ work for scientific accuracy and compliance.
• Responsible for maintaining GMP laboratory environment and maintaining a safe, clean cGMP environment.
• Execute product development/ Tech transfer work plan/schedule developed with input from supervisor or senior team member.
• Draft technical documents such as batch records, stability protocols, technical reports and protocols with supervisor guidance.
• Assist in the execution of efficiency improvement project with guidance.
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs.
• Work with customer and CCU operation group members to conduct tech-transfer batches under supervisor’s directions.
• Provide a manufacturing procedure to the Operation Group for commercial production.
• Assist the production/R&D department in the execution of development/ scale up/ tech transfer/ submit batches
• Prepare technical documents for execution of study protocol and study reports as required.
• Assures experimental quality through sound experimental design and utilizes DOE.
• Collaborate with customers in finalizing the documents, procedures and updating the progress of the projects
• Promote the company’s image through participation in conferences and seminars.
QUALIFICATIONS:
• Bachelor’s degree in pharmacy, pharmaceutical sciences, chemical engineering or Chemistry
• At least 5 to 7 years’ experience in a pharmaceutical process/product development and/or tech-transfer environment.
• Working knowledge of the theories and manufacturing processes associated with the experimental manufacture of oral solid, Liquids and Powder for suspension drug products.
• Familiar with technologies including Fluid Beds, High Shear Granulators, Tablet Presses, Tablet Coaters, Blenders, Mills, etc.
• 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.
• Good verbal and written communication skills in Japanese, computer skills in word processing, spreadsheets, and some technical software.
PHYSICAL REQUIREMENTS:
Must be accessible to all laboratory, manufacturing, and office areas. Must be able to climb ladders safely. Must be able to wear the required PPE/PAPR for entering processing area. Specific vision requires include reading of written documents and use of a computer. Must be able to sit or stand for prolonged periods, and occasionally lift up to 50 lbs.
To apply, please email your resume to xjiang@pasona.com
