Scientist needed in Bridgewater, NJ in the pharmaceuticals industry. He/She who applies is responsible for independently developing and validating analytical methods for active pharmaceutical drug substance and drug products. Provide analytical input in support of product development to formulation group. Write and update SOPs, validation protocols, reports, test procedures and specifications. Maintain laboratory notebooks and lab instruments in compliance with internal SOPs and current USP, FDA guidance. Communicate results in written and oral presentations.
Our client is a global generic pharmaceutical company that excels in their field. As a part of this company, you will be making an impact in the world of pharmaceuticals with the research you conduct.
- Ability to develop and validate analytical methods for drug substance and drug products.
- Write and execute analytical test procedures for the analysis of raw materials and finished products. Write and review analytical method validation protocols, reports, and technical documents.
- Write and update Analytical R&D SOPs Conduct laboratory OOS investigation in accordance with internal SOP, write and review investigation and Deviation reports.
- Provide analytical support for new product development and participate in technical discussions with the formulation group, CRO and CMO.
- Capable of self-scheduling of work assignments.
- Assures right-first-time execution of methods and SOPs. Lead all analytical method transfer activities.
- Provide support for ordering and maintaining inventory of laboratory material and equipment.
- Participate in inter-department task teams.
- Perform all other duties as assigned, or as business needs require.
- MS or BS degree in chemistry, biology or other related scientific discipline required.
- 5+ years of experience in the pharmaceutical industry with the emphases on methods development and validation.
- Experience with pharmaceutical laboratory equipment such as HPLC, UV, GC, Dissolution, IR, etc. is required.
- Experience in executing USP and EP test methodology is required.
- Ability to work effectively under pressure to meet deadlines.
- Excellent verbal and written communication skills
- Good knowledge of FDA guidelines, ICH and related guidelines.