Principal Scientist, QC Technical Services
Summary:
The Principal Scientist, QC Technical Services will be a key member of the QC Technical Services group working in a virtual quality control and technical management environment and will lead technical activities associated with quality control of commercial products. This position will remotely manage analytical activities at global testing facilities, work closely with commercial quality control and other CMC departments, and be responsible for authoring submissions and responses to regulatory agencies.
Responsibilities:
This position will provide key technical support in all areas of commercial quality control activities, Lead activities focused on the development and assessment of specifications attributes and acceptance criteria. Lead development of control charts and monitor product quality and method performance. Review these charts for trends and take action as necessary. Develop protocols and prepare reports for method transfers and comparability studies Lead method lifecycle projects and validate methods. Support investigations, critical reagents, and stability studies by providing technical insight. Author regulatory submissions and responses related to specification and analytical topics. Develop working relationships with contract testing laboratories and manage assigned analytical activities. Author SOPs Work collaboratively with Commercial and Clinical Quality Control, Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, and Project Management to ensure timely completion of analytical projects supporting commercial products and aligned with corporate goals. Qualifications B.S. degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field with at least 12 years relevant experience in quality control and/or analytical development in pharmaceutical setting or M.S. with at least 10 years of experience. Prefer Ph.D. with at least 8 years of experience relevant to the responsibilities of this position and strong interest in analytical sciences and their applications to commercial bio/pharmaceuticals.
Salary Range:
$100K -- $150K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
