Senior Scientist, Formulations

Job Description
Job Summary:

Provide technical leadership in Formulations to enable the formulation and product development, scale up and manufacturing process optimization in support of NDA and ANDA submissions. Implement systems necessary for product development in a regulated environment.

Essential Duties and Responsibilities:.

∑ Provide technical leadership in the development, scale up and manufacturing process optimization of formulas. Support manufacturing, validation and other depts through timely development and execution of scale up and trouble shooting. Understand CMC requirements for projects worked on and create opportunities to shorten timelines by taking initiative in a group environment. Design experiments and evaluate data, while providing guidance to junior level scientists in experimental design and data evaluation. Responsible for interpretation of data necessary for specification setting on projects managed for submission to regulatory agencies.

∑ Conduct, as needed, non-routine and routine formulation development (develop and evaluate new technologies) in support of projects. Analyze and interpret results in written and oral format. Make presentations at cross-functional team meetings and management meetings.

∑ Write and review project reports from a global, cross-functional perspective. Evaluate results and provide solutions to ongoing problems. Proactively identify and solve problems. Track projects and timelines. Present results to management. Interact with other groups, including outside contract laboratories, in solving problems.

∑ Maintain accurate lab notebooks and complete all related development reports, in compliance with SOPs. Perform notebook review. Ensure notebooks are reviewed in a timely manner, in accordance with SOPs.

∑ Review CMC sections of ANDAs and NDAs. Provide responses to deficiency letters from regulatory agencies. Interact with FDA investigators during Pre-Approval inspections.

∑ Evaluate and contribute to scientific literature to enable innovation in analytical development.

∑ Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Par Safety Practices.

∑ Completely responsible for projects from concept through ANDA filing.

∑ Focused on personal or subordinate projects with contribution to other Par projects in meetings and conference calls.

∑ Provides technical leadership and guidance.

∑ Participates in problem solving for formulation and process.

∑ Performance appraisal responsibility

∑ Responsible for maintenance of GMPs and GLPs in the R&D manufacturing area amongst the scientific staff.

∑ Senior scientists may function as team leaders.

Job Requirements :

Education and or Experience:

∑ Sufficiently skilled in formulation craft to supervise and train less experienced formulators.

∑ Minimum 5 years formulation experience.

∑ Must display good planning, coordination and communication skills.

∑ Interpretation of analytical and bio data is requisite.

∑ Sr. Research Scientist and Principal Scientist are similar positions with similar responsibilities. The determination of level is based on the incumbentís education, experience and ability to handle more complex and advanced work and responsibilities including, but not limited to:

o Project leadership

o Cross-functional interactions and problem solving

Company

Anchen Pharmaceuticals

Job Code

State or Province

California

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