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Scientist I

The Scientist I carries out technical projects as assigned by the head of Product Development. He/she is responsible for formulation and process development associated with technology transfer and/or ANDA projects.
Position Accountabilities
Position Responsibilities:
Primarily responsible for supporting the needs of technology transfer projects and ANDA development projects.
Authors and executes documents such as protocols, reports, batch records, and technical assessments.
Plans experiments and analyzes data. Records data in laboratory notebooks.
Able to use statistics to plan experiments and analyze data (e.g. Design of Experiments, Statistical Process Control, Process Capability)
Evaluates equipment purchases for applicability.
Evaluates physical characteristics of new raw materials.
Provides Manufacturing, Validation, Packaging, and Regulatory Affairs, with technical input.
Maintains Department SOPs.
Assists in training operations on new products/processes.
Effectively communicates cross-functionally
Assists with improving department infrastructure and procedures. Helps to develop best practices. Initiates, creates and revises SOPs as appropriate. Assists Manufacturing and Packaging with process and packaging related investigations. Researches and prepares Technical Assessments, as required. Performs other duties as assigned or requested.
Position Requirements:
Bachelors, Masters or Ph.D. in Chemical Engineering, Chemistry, Biology, or a related life science.
Two years of college or vocational education in a scientific field
High school diploma
Experience:
Minimum of 3 years with a M.S., minimum of 5 years with a BS degree, minimum of 12 years with an AS degree, or minimum of 15 years with a HS diploma.
Experience must be in product development, technical services, or other form of manufacturing support.
Minimum Field of Expertise:
Ability to coordinate multiple projects in a fast paced environment.
Demonstrated ability to perform in a team environment.
Excellent communication skills
Excellent organizational and follow-through skills
Interpersonal skills
Troubleshooting ability
Understanding of cGMPs
Preferred Field of Expertise:
Ability to plan, organize, and implement development project plans and objectives
Demonstrated leadership skills
Previous pharmaceutical industry experience
Previous ANDA development experience
Strong technical writing ability
Familiarity with ANDA submission requirements and related FDA guidance documents (e.g. split tablet evaluation, Quality by Design, stability, etc.)

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