What are the responsibilities and job description for the Scientist-II – Analytical R&D position at Scientific Search?
Location: Allentown, PA
Scientific Search, a specialty pharmaceutical company engaged in the development and commercialization of generic and branded pharmaceutical products, has an immediate need for a Scientist II, Analytical R&D. This is a 6-month contract-to-hire or direct hire position with a dynamic organization.
The Analytical R&D Scientist II is responsible to develop and establish new analytical methods using advanced analytical techniques that meet the expected FDA standard, independently or under the supervision of a Senior Scientist. The primary focus will be on the development of oral solids, liquids and semi solids for FDA applications. Analytical R&D Scientist – II should be able to work on the bench, manage projects while working with other scientists and collaborating with other departments.
Responsibilities
Check out scientificsearch.com for all current openings
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Scientific Search, a specialty pharmaceutical company engaged in the development and commercialization of generic and branded pharmaceutical products, has an immediate need for a Scientist II, Analytical R&D. This is a 6-month contract-to-hire or direct hire position with a dynamic organization.
The Analytical R&D Scientist II is responsible to develop and establish new analytical methods using advanced analytical techniques that meet the expected FDA standard, independently or under the supervision of a Senior Scientist. The primary focus will be on the development of oral solids, liquids and semi solids for FDA applications. Analytical R&D Scientist – II should be able to work on the bench, manage projects while working with other scientists and collaborating with other departments.
Responsibilities
- Analytical R&D Scientist-II will be responsible for developing and /or validating HPLC/GC and other analytical test methods, and optimizing existing test method independently or under the supervision of a manager,
- Performs analytical testing on R&D batches and associated stability studies and generate stability analysis report.
- Analytical testing will include Assay, preservative content, LOD, water content, identification test, dissolution, disintegration, residual solvents, related substances etc.
- Provide mentorship, training and guidance to associate level staff and contribute to their development.
- Performs experiments and studies such as reverse engineering, compatibility studies, degradation studies independently or under the supervision of a Senior Scientist.
- Assist in writing protocols, reports and technical documents including but not limited to development, validation and study.
- Ensure compliance with DEA and site requirements regarding the handling, use and disposal of controlled substances.
- Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines
- Bachelor’s Degree (BA/BS) in chemistry or other relevant pharmaceutical sciences is required with minimum of 5 years of experience in analytical method development and validation.
- Master’s degree (MS/MA) in chemistry or other relevant pharmaceutical sciences is required with a minimum of 3 years of experience in analytical method development and validation.
- Comprehensive knowledge of Good Manufacturing Practices, FDA/ICH Guidelines, and Compendial references (USP/Ph. Eur., etc.).
- Experience using laboratory instrument data acquisition software (Empower, ChemStation etc.).
- Experience using laboratory Management System (Labvantage etc.).
- Experience with Microsoft Office (Word, Excel, Power Point, etc.).
- Proven verbal and written communications skills.
- Good subordinate and peer relationship skills.
- A strong demonstrated belief in continuous improvement.
- Good knowledge of cGMP, FDA and international regulatory requirements
- General personal computer skills – word processing, spreadsheet, graphics, and database.
- Proven concern with working in a safe and environmentally correct manner.
Check out scientificsearch.com for all current openings
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