Analytical Scientist II

• Responsible for creating and managing project documentation, including change control documents, raw material specification, forms, protocols, reports, and other documents as assigned to support AR&D needs.
• Co-ordinate with QA for Change request for all project related activities.
• Co-ordinate with QA department to make specification/test methods effectiveness.
• Responsible for coordinating with the Purchasing Department as required for API related documents to support project needs. 
• Responsible for assisting with the DMF review.
• Responsible for assisting in communication of general AR&D requirements to other departments.
• Responsible for supporting or assisting with the stability protocol preparation.
• Responsible to co-ordinate with regulatory department for any analytical documents requirements.
• Responsible for operating in accordance with the company’s Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Other related responsibilities as assigned by R&D management.

Major Duties

• Creation of specifications for raw materials and supplies for R&D projects, and collection of documents required to support raw material assessments
• Creation of method validation/verification/transfer Protocols/reports, analytical test procedure, summaries, and other related documentation.
• Review and assess DMF to support API related analytical documents for development projects
• Work with offsite groups to assist with the transfer of information to the Aveva site in support of R&D Projects
• Assist with the document review, preparation of project requirement, data compilation to support project requirements under supervisor guidance.
• Carry out change control process for any document preparation in trackwise system.
• Work with AR&D leads to satisfy project requirements.

Job Requirements

• Education
  • Bachelor’s degree (B.S.) in chemistry or related field
  • Master’s degree (M.S.)

• Knowledge, Skills and Abilities

• Strong organizational and communication skills, ability to work effectively with internal and external team members and work effectively as a team member
• Ability to track project tasks and deliverables
• Strong writing skills and ability to write clear, concise, documents of a technical nature
• General knowledge of the pharmaceutical work environment, such as GMP and safety practices
• Computer skills including MS Word, Excel, Powerpoint, and other relevant software programs
• Analytical chemistry and common instrumentation
• General understanding of HPLC, GC, Drug Release, UV, IR, Titration.
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• Experience
  • At least eight (8) years experience in pharmaceutical laboratory (B.S)
  • At least five (5) to seven (7) years experience (M.S.)