Our client, a leading contract development and manufacturing organization (CDMO) based in the US, is seeking a QC Chemist Manager to join their growing team. This is a great opportunity to contribute to the development and commercialization efforts.
Pay: 105k-110k/year
Location: Union County, NJ
Shifts: Sun-Wed (9pm-8am), Sun- Wed (7am-6pm)
Responsibilities:
- Oversee and conduct QC testing, while preparing and maintaining stability records and summaries.
- Develop, train, and transfer methods to and from QC and contract manufacturers as needed.
- Modify and validate analytical procedures to meet QC requirements.
- Design and develop experimental protocols, SOPs, and related documentation in line with cGMP/GLP standards.
- Perform all QC chemical tests required for batch release to ensure patient safety.
- Participate in and lead special projects, providing input, feedback, and executing assigned tasks.
- Tackle special projects focused on analytical and instrumentation problem-solving.
- Perform timely microbiological QC, ensuring product quality records are accurate.
- Maintain, operate, and adapt analytical instrumentation as needed.
- Ensure a clean, safe work environment that complies with safety and pharmaceutical regulations.
- Conduct safety tasks in accordance with regulatory standards.
- Report monthly on QC supply orders for devices and reagents.
- Contribute to industrial, R&D qualification, and validation activities, while supporting routine maintenance.
- Lead laboratory investigations and root-cause analyses.
- Prepare chemical reagents for manufacturing and QC processes.
Qualifications:
- A minimum of 5 years of GMP QC laboratory experience, including leadership experience.
- Strong organizational skills are essential.
- Bachelor’s degree in chemistry or Biochemistry is required.
- Proficiency with analytical techniques, including High-Performance Liquid Chromatography (HPLC)
- Excellent oral and written communication, organizational, and problem-solving skills, with the ability to work under strict timelines.
- Ability to simplify complex ideas for management and customers, and exercise independent judgment during method development and transfer processes.
- Knowledge of current analytical methods for testing, release, and stability of sterile pharmaceutical products.
- A team-oriented mindset, with the ability to work effectively with cross-functional teams.
- Proficiency in Microsoft Word and experience with Laboratory Information Management Systems (LIMS).
