SC.AS.Senior Scientist, Product Development
ProClinical is currently seeking a Senior Scientist I/II for a pharmaceutical company, located in Minnesota. The successful candidate will be responsible for independently leading technical projects as assigned by the head of Product Development. Additionally, responsible for formulation and process development associated with technology transfer and/or ANDA projects.
- Executing documents such as protocols, reports, batch records, and technical assessments.
- Planning experiments and analyzing data. Recording data in laboratory notebooks.
- Using statistics to plan experiments and analyze data.
- Evaluating equipment purchases for applicability.
- Evaluating physical characteristics of raw materials.
- Providing Manufacturing, Validation, Packaging, and Regulatory Affairs, with technical input.
- Maintaining Department SOP's.
- Assisting in training operations on new products/processes.
- Improving department infrastructure and procedures.
- Initiating, creating and revising SOP's as appropriate.
- Assisting Manufacturing and Packaging with process and packaging related investigations.
- Researching and preparing Technical Assessments as required.
- Performing other duties as assigned or requested.
Skills and Requirements
- BS, MS, or PhD in Chemical Engineering, Chemistry, Biology, or a related life science.
- Two years of college or vocational education in a scientific field.
- High school diploma.
- 4+ years with a PhD, 7+ years with a MS, 9+ years with a BS degree, 12+ years with an AS degree, or 15+ years with a HS diploma.
- Experience must be in product development, technical services, or other form of manufacturing support.
- Familiarity with ANDA submission requirements and related FDA guidance documents.
- Demonstrated ability to perform in a team environment.
- Excellent communication, interpersonal, organizational, and follow-through skills.
- Troubleshooting ability.
- Understanding of cGMPs.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Andrew Shen at (+1) 646-367-1089 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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