Affiliated with Medisca, CED Analytical Labs is looking to fill the role of a Team Lead, Stability Chemist. The role will play a pivotal role in ensuring the stability and integrity of our products through meticulous testing and analysis. In addition to conducting stability studies, you will be responsible for leading and supervising a team of stability chemists, coordinating activities, and ensuring compliance with regulatory standards. They will manage multiple projects within tight timelines, ensuring the requirements of each are met with the highest degree of accuracy and efficiency.

Responsibilities & Duties:

Stability Operations

• Coordinate testing with chemists under their direction to ensure optimal timelines are met.
• Support with troubleshooting
• Own the investigation process; completing or assigning any follow-up testing that needs to occur, as well as completing all relevant investigation paperwork and submit to Quality for final approval.
• Ensure lab training for analysts is completed for specified requirements.
• Participate in project teams to provide stability related input and support.
• Responsible for the initial review of methods and protocols. Suggesting appropriate standards and testing materials (i.e.. Columns etc.)
• Identify opportunities for process improvements and efficiency enhancements within the stability testing function.
• Manage the stability chambers, responsible for reporting any temperature deviations and providing support in completing any deviation paperwork that may be required as a result.

Stability Testing

• Assume ownership of all stability programs, covering a comprehensive spectrum from raw materials and Research and Development (R&D) to finished products.
• Coordinate with third party labs when tests need to be outsourced.
• Perform analytical testing using USP stability indicating methods per the customer established protocols precisely each time.
• Perform accelerated and real-time stability testing, stability indicating assays, and degradation studies.
• Work cross-functionally with the Research and Development team, to design stability studies for their projects
• Maintain accurate and detailed records of stability testing procedures, results, and analysis. Entering results into the Laboratory Information Management System (LIMS).
• Support the Quality department in releasing certificates of analysis’s (CoA’s) when needed.
• Create trend data and reports for the Quality Department
• Coordinate testing of multiple programs with the lab staff to ensure testing pulls are completed timely without compromising regular sample testing.
• Ensure team is following all laboratory SOP’s and guidelines to ensure compliance with all FDA and DEA regulations.

Team Development

• Coach and help develop the team’s skill set by cross training them
• Coordinate daily activities, prioritize workload, and ensure efficient utilization of resources.
• Conduct performance reviews and continuously provide feedback.

Laboratory upkeep and inventory:

• • Maintain organized and tidy laboratory areas and workspaces.
  • Ensure all instruments used are well maintained and the workspace is kept neat.
  • Clean and store glassware regularly
  • Calibrate and perform verification checks on routine use testing equipment and instrumentation.
  • Request new materials and inventory to support the stability program.

Ensure team is following all PPE and safety protocols.

Perform other duties as assigned

Qualifications:

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences or related field
• Three (3) to five (5) years of laboratory experience performing analytical testing
• Two (2) to three (3) years performing stability testing
• Equipment knowledge: HPLC, GC, IC, pH, titrators, UV-Vis,
• Working knowledge of cGMP/GLP, ICH, USP/NF, EP, and FDA regulations
• Experience working with a Laboratory Information Management System (LIMS)
• Knowledge of Microsoft Office suite (Word, Outlook and Excel) required
• Excellent communication skills; fluent English (oral & written) required
• Demonstrated leadership experience with a strong ability to lead and motivate a team
• Manage and prioritize multiple projects
• Excellent time management and organizational skills
• Able to work under pressure and successfully function in a fast-paced environment
• Demonstrates corporate values in the performance of the work and interactions with others

What’s In It For You …

We invest time and resources into making sure CED is as good as the people we hire.

Balance Your Life – PTO, vacation policy and paid statutory holidays

• Invest in your health – Group Benefit plan and health savings account
• Your Future is Bright – Opportunities to learn and grow within CED
• Save for your Future – 401k plan retirement
• Help us grow – Employee Referral Program
• We like to have fun – company events throughout the year

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.
We are an equal opportunity employer.