• Experience operating a variety of analytical equipment (e.g. HPLC, UPLC, Karl Fischer, etc.)
• Maintain and perform daily operations of the QC Stability program on a daily basis in coordination with the QC Director/Supervisor to include stability testing of peptide samples and prioritizing projects
• Implement and maintain GMP procedures such as following SOPs, STPs, written procedures and maintaining proper documentation as necessary for Quality Control stability testing program
• Test and review stability data for stability reports of peptide stability samples for stability program. This includes performing analyses and reviewing data for completeness and accuracy.
• Maintain a cGMP quality level of work for the QC Stability Program to include training documentation and procedural work.
• Write and maintain applicable SOPs. Write/revise specifications as necessary.
• Provide analytical support to other functions of Quality Control, Purification and Synthesis, as applicable
• Coordinate testing activities with other QC Scientists for meeting stability timelines.
• Maintain the stability chambers and stability inventory for stability program.
• Review laboratory notebooks, logbooks, protocols and reports, as applicable
• Investigate any deviation or out of specification as necessary related to QC stability testing as instructed by supervisor
• Assist management during inspections and internal audits
• Work with clients to include teleconferences/meetings, exchange of data/information for stability program
• Schedule use of equipment and coordination of instruments with other QC scientists, as necessary
• Follow safety guidelines for handling, disposal of toxic and / or large volumes of chemicals
• BS degree in Chemistry, Biochemistry or related discipline
• Over 8 years’ experience in the pharmaceutical or biotech industry
• Use of analytical techniques / instruments, such as HPLC, KF, GC, etc., and computer skills is highly desirable.
• Knowledge of ICH Q1 and ICH Q7, cGMP and FDA regulations
• Ability to effectively organize, multitask, and work in a fast-paced environment
• Excellent written and oral communications skills
• Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
• Exhibit professional interpersonal skills
• Communicate effectively and ability to function well in a team environment
• Exhibit detail oriented documentation skills
• Ability to work independently and manage one's time
• Basic computer knowledge, including Microsoft Word and Excel
• Coordinate testing activities with other QC Scientists for meeting stability testing schedules.
• Maintain the stability chambers and stability inventory for stability programs.
• Ability to convey to customers and regulatory agencies the stability program rationale and status
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Master’s degree in Chemistry or related discipline
• Experience with peptides