Senior Scientist I

The Senior Scientist I independently leads technical projects as assigned by the head of Product Development. This includes responsibility for formulation and process development associated with technology transfer and/or ANDA projects.
Position Responsibilities: Primarily responsible for managing technology transfer projects and ANDA development projects. This includes: 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. Assists Manufacturing, Validation, Packaging, and Regulatory Affairs, with technical input. Maintains Department SOPs. Assists in Training operations on new products/processes. Provides technical input on investigations and/or CAPAs associated with manufacturing and packaging of marketed products. Identifies process improvements. Performs activities needed to support alternate API filings. Assists with improving department infrastructure and procedures. Helps develop best practices related to marketed product support and/or technical writing. 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: This position requires a Bachelors degree with a minimum of 9 years experience, or a Masters degree with a minimum of 7 years experience, or a or Ph.D. with a minimum of 4 years experience. All degree majors are required to be either Chemical Engineering, Chemistry, Biology, or a related life science. AS Degree in a scientific field with a minimum of 12 years experience. A HS Diploma with a minimum of 15 years experience. Experience for all levels of education must be in product development, technical services, or other form of manufacturing support.
Minimum qualifications include the ability to coordinate multiple projects in a fast paced environment. Demonstrated ability to perform in a team environment. Excellent communication and interpersonal skills. Excellent organizational and follow-through skills. Troubleshooting ability. Understanding of cGMPs.
Preferred qualifications include the ability to plan, organize, implement, and product transfer projects, plans and objectives. Demonstrated leadership skills. Previous Pharmaceutical industry experience. Proven ANDA development experience. Familiarity ANDA submission requirements and related FDA guidance documents (e.g. split tablet evaluation, Quality by Design, stability, etc.)

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