The Staff Scientist provides analytical chemistry support and/or remediation to all projects for products currently on the market as well as products under development while in observance of product development and domestic/global regulatory and internal quality system requirements. This role is key to the overall conduct of the stability testing program to support the approval of processes and/or drug product changes. As required, this position supports the development, validation and transfer of methodologies for incoming raw materials, in process, finished product release and stability testing. The incumbent will have expert skills in pharmaceutical analytical chemistry as well as experience in authoring CMC sections of regulatory submissions. The candidate must possess an understanding of the pharmaceutical/medical device development process throughout the products life- cycle to deepen collaboration with multi-functional teams seeking to develop new products in support of surgical product portfolio. The Staff Scientist is expected to find opportunities to improve the efficiency of internal laboratory systems by creating and or updating processes that are in compliance with quality policies and procedures.
Demonstrates developed knowledge of scientific expertise, methods and techniques.
Applies knowledge and skills to a wide range of standard and non-standard situations.
Expert knowledge of separations sciences (liquid chromatography, gas chromatography, phase extractions, purification, TLC).
Specialist in the development and application of molecular techniques (UV-Vis, FTIR, NIR, Raman) in Process Analytical Technology (PAT).
Expert knowledge in method development, validation and transfer of procedures per ICH and global pharmacopoeia requirements.
Expert knowledge of wet chemistry techniques (pH, weighing, titrations) as well as understanding of any pharmaceutical/pharmacopoeia requirements.
Understands market and customer needs and products.
Possesses understanding of product development process, regulatory, and quality requirements pertaining to pharmaceutical product development.
Competent technical writing skills pertaining to the SOP development and drafting of reports based on a given targeted audience.
Captures, documents and communicates project related information from different sources.
Works in teams and creates partnerships; communicate results and needs to senior technical colleagues and suppliers.
Proficient with the use of statistical techniques as applicable Eo measurement system analysis, process validation, design of experiments and evaluation of stability data.
Possesses mathematical and reasoning ability, interprets a variety of instructions furnished in written, oral, diagram, or schedule form.
Defines problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions.
Organizes and prioritizes work with limited guidance and manages projects in a timely manner. Ability to multi-task various activities.
Reorganizes and reschedules work on short notice in order to meet revised deadlines.
Works with colleagues and multiple clients in a professional and organized manner and interact effectively with a variety of people from different nationalities and backgrounds.
Understanding of FDA requirements related to product development and chemical testing requirements for products and GxP documentation requirements.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to discuss strategies/results and interact with other functional areas, including Regulatory, Manufacturing, and Quality.
Acts a resource for colleagues with less experience.
Knowledge of the requirements for pharmaceutical products in major global markets (i.e. US, Europe).
Experience with medical devices (21CFR820) is helpful but not essential.
PhD or MS/BS in Chemistry or Biochemistry/Pharmaceutics with related science experience.
Minimal of 10 years of demonstrated experience in the field of pharmaceutical analysis to include topical or liquid dosage forms, i.e. solutions, suspensions, emulsions, micro-emulsions, etc.
Leading all aspects of the conduct of stability testing programs for pharmaceutical products in observance of domestic and global guidelines and requirements.
Possesses demonstrated experience in working under an FDA regulated environment and has mastery of GMP documentation requirements.
Experience with validation of analytical methods per ICH guidance requirements.
Experience with requirements for laboratory data Integrity.
Lead and direct project team, including Identifying, directing, and delegating tasks necessary for successful regulatory project completion.
Previous experience with interpretation of scientific results and writing scientific documents to support submissions in major global markets.
Previous experience with writing scientific protocols and reports.