Development Scientist / Senior Scientist - Formulation

*Must be fluent in speaking, writing, and reading Japanese*

Do you have experience working with either generic or branded OSD products? Would you like to contribute that experience to a global pharmaceutical company?

Our client is a global CDMO located in New Jersey. The site in New Jersey is focused on oral solid dose development and manufacturing of both generic and branded products. Globally the company has been in business since the 1980’s and here in the US they have been growing their operations since the early 2000’s. They are unique in the services they offer to be able to work with a pharmaceutical client from end to end on their drug product programs.

This position is a new position for the research and development team and an instrumental one in being able to deliver timely results for the current and future clients. This position will report to the Senior Manager Technical Services.

The Scientist professional should possess a strong background in oral solid dose formulation and scale -up and technical transfer activities from development to commercialization and lifecycle support. This is a hands on laboratory position.

RESPONSIBILITIES:

• 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 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 operation group members to conduct tech-transfer batches under supervisor’s directions.
• Provide a manufacturing procedure to the Operation Group for commercial production.
• Work with 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.
• Assures experimental quality through sound experimental design and utilizes DOE.
• Promote the company’s image through participation in conferences and seminars.
• Prepare batch records, specifications, procedures, and SOPs as needed.

QUALIFICATIONS:

Bachelor’s degree in chemistry, biology, pharmacy, chemical engineering, or related field.

• At least 5-8 years’ experience in a pharmaceutical process/product development environment.
• Working knowledge of the theories and manufacturing processes associated with the experimental manufacture of oral solid drug products specifically and pharmaceutical products in general.
• 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.