Manager, Quality Control

Your Responsibilities

The Manager, Quality Control fulfills a critical role in active pharmaceutical ingredient development and manufacturing operations.  This individual manages quality control and analytical method development & validation activities for the in process control (IPC) to support production and process R&D within the QC department in compliance with cGMP. 

Your Tasks

• Maintain and coordinate the operation of the IPC group to meet client/company/regulatory goals.  This includes assign, prioritizing, and monitoring work for the group members on a regular basis.
• Review laboratory notebooks, raw data, development/summary reports, methods, protocols and operational SOPs as necessary.
• Oversee the execution of analytical activities and ensure these activities meet the quality requirements and in compliance with relevant regulations
• Attend project/production meetings as a SME representing QC. Proactively plan analytical activities to ensure these activities will meet projects timelines. Actively communicate with internal and external customers to provide them solutions to meet project timelines with high quality.
• Author and/or review protocols, reports, and project updates.  Write/review standard operating procedures, standard test procedures and other related cGMP documentation.  Review data for completeness and accuracy.
• Maintain up-to-date scientific knowledge pertaining to the field of analytical chemistry (e.g. theories, practices, equipment and technology), as well as regulatory requirements
• Work with R&D, QA, RA, CMC and MFG to ensure our supports are meeting their needs.
• Maintain the instruments in the lab and ensure they are qualified and are operational.  Schedule use of instruments and coordination of instruments with other groups
• Work with QA to help maintain GMP and ICH compliance

Your Profile

• Ph.D. in Chemistry, Biochemistry or related field with a minimum of 5 years’ experience in peptide/small molecule analytical chemistry or
• Master’s Degree in Chemistry, Biochemistry or related field with a minimum of 7 years’ experience in peptide/small molecule analytical chemistry or
• Bachelor’s Degree in Chemistry, Biochemistry or related field with a minimum of 9 years’ experience in peptide/small molecule analytical chemistry
• Broad knowledge of modern analytical chemistry
• Hands-on experience with HPLC/UHPLC, IC, GC, LC-MS
• Experience with QC or method development
• Experience writing standard operating procedures (SOPs) and technical reports
• Prior supervisory and project management experience
• Creativity to solve technical and compliance problems
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint.  Experience with Microsoft Project is a plus
• Ability to effectively organize, prioritize, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one’s time
• Communicate effectively and ability to function well in a team environment
• Experience with Microbial and Endotoxin Validation will be a plus