Scientist I, Product Development
ProClinical, in support of our client, are seeking an individual to fill the role of Scientist I, Product Development, based in Baudette, MN. The successful candidate will carry out technical projects as assigned by the head of Product Development.
- Author and execute documents such as protocols, reports, batch records, and technical assessments.
- Plan experiments and analyze data. Record data in laboratory notebooks.
- Use statistics to plan experiments and analyze data.
- Evaluate equipment purchases for applicability.
- Evaluate physical characteristics of new raw materials.
- Provide Manufacturing, Validation, Packaging, and Regulatory Affairs, with technical input.
- Assist in training operations on new products/processes.
- Assist with improving department infrastructure and procedures. Helps to develop best practices.
- Initiate, create and revise SOPs.
- Assist Manufacturing and Packaging with process and packaging related investigations.
- Research and prepare Technical Assessments, as required.
Skills and Qualifications
- BA, MA or PhD in Chemical Engineering, Chemistry, Biology, or related field and 3-15 years of relevant experience.
- Experience with product development, technical services, or other manufacturing
- Excellent written, verbal, and interpersonal communication skills.
- Understanding of cGMPs.
- Ability to plan, organize, and implement development project plans and objectives.
- Previous pharmaceutical industry experience.
- Previous ANDA development experience.
- Familiarity with ANDA submission requirements and related FDA guidance documents.
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 Jason Thiagaram at (+1) 646-367-2910 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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