Description:
Global - Pharmaceutical Company (NJ)
Associate Director of Analytical Development (Salary Open for nego) - Korean Bilingual
Main Duties & Responsibilities:
Identify, select, and manage CROs providing analytical chemistry services.
Lead the development of analytical procedures in support of pharmaceutical drug substance and product development projects.
Responsible for process improvement activities. Able to zero in and identify areas of opportunity for improvement of analytical methods.
Ensure that analyses of experimental and stability samples are conducted strictly in accordance with cGMPs, company's SOPs and protocols.
Ensure that all laboratory documentation is completed to the highest quality standards and that any formal investigations e.g. Out of Specification (OOS), Changes or Deviations in Data, are conducted promptly and thoroughly
Convey results of analytical studies and participate in project discussions within development teams.
Keep up to date with technical advances in analytical and pharmaceutical sciences.
Stay abreast of current trends in regulatory requirements in the field of CMC.
Responsible for preparation and/or review of the analytical chemistry portion of the CMC section of a drug product regulatory submission (INDs, NDAs, ARs).
Pre-formulation studies in order to provide data on APIs that will lead to development of suitable pharmaceutical products
Review and approve all analytical method development protocols and reports.
Review and approve all release and stability specifications.
Manage the activities of one chemist in order to ensure that studies are completed in accordance with project timelines and expectations.
Requirements:
Ph.D, M.Sc., or B.Sc. in a science related to Pharmaceutical Analysis
Ph.D. with 6 years or M.Sc. with 12 years or B.S. with 15 years of pharmaceutical analytical development experience in the pharmaceutical industry
Good understanding of analytical method validation requirements of pharmaceutical industry
Good understanding of the chemistry of pharmaceutical APIs and of analytical techniques for their characterization
Candidates must have a good theoretical knowledge of chromatographic sciences and spectroscopic technologies e.g. HPLC, UV, IR, MS, NMR, XRD
Very positive interests in keeping up to date with new technologies and developments in analytical sciences
Good understanding of cGMP, ICH and FDA requirements
Experience in preparing CMC section of regulatory submissions
Comfortable working in a virtual environment
Computer literate
(Knowledge of Korean language is plus)

Experience:
Ph.D, M.Sc., or B.Sc. in a science related to Pharmaceutical Analysis
Ph.D. with 6 years or M.Sc. with 12 years or B.S. with 15 years of pharmaceutical analytical development experience in the pharmaceutical industry