Scientist IV, Global Pharmaceutical Technical Support

Duties & Responsibilities

• Develops, validates, and transfers robust analytical methods for testing of raw materials, excipients, APIs and finished products to BI QC labs and to the QC labs of CMO.
• Performs routine and non-routine testing related to investigational samples.
• Records, evaluates, interprets and summarizes technical data.
• Performs instrument troubleshooting.
• Prepares protocols, memos, reports, and regulatory documents.
• Able to deliver results for multi tasks and work in a team environment to meet business needs.
• Organizes and presents the results of work internally and externally.
• Functions as in-house consultant for areas of technical expertise and provide technical supervision to junior scientist as needed.
• Provides technical expertise in planning, execution of planned experiments, monitoring, and maintaining project timelines to meet business needs.
• Reports and treats data with a high level of integrity and ethics.
• Understands and complies with applicable regulations, performing all work in a safe manner; maintains proper records in accordance with Standard Operating Procedures (SOPs) and policies.
• Participates in cross departmental project teams when assigned.

Requirements

• PhD from an accredited institution in Analytical Chemistry (preferably on Separation Sciences Techniques) or related field of Chemistry.
• Knowledge and experience on Analytical Chemistry on various Techniques/Technologies, preferably in the area of Separation Sciences Techniques, and or related fields such as Physical Organic Chemistry, Physical Chemistry and or other related fields.
• Expertise in separation sciences techniques and other state-of-the-art analytical techniques and technologies.
• Knowledge of cGMP regulations, ICH/VICH guidelines, and compendia monographs/methods is preferred.
• Good ability to work with others to accomplish project goals.
• Plan and conduct scientific/laboratory experiments, evaluate and interpret data.
• Provide training and guidance to junior laboratory personnel.
• Prepare technical reports, publications and oral presentations.
• Possesses in-depth knowledge and thorough understanding of USFDA, EMEA and other health regulatory requirements.