Supervisor, Chemistry

Responsibilities

• Plan and schedule work according to laboratory needs.
• Participate in laboratory budgets planning, including ordering equipment and supplies, ordering consumables, and tracking costs.
• Serves as a department representative in cross-functional working teams and/or working with outside customers to meet stability testing needs.
• Ensure all testing is conducted according to cGMP principles.
• Review analytical method verification, validation and analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA).
• Participate in investigations of Out of Specification (OOS) test results as needed follow FDA guidelines.
• Manage and maintain compliance with relevant regulatory requirements (e.g. ICH and FDA) related to testing and data documentation.
• Maintain a clean, safe work environment, comply with safety policies, and dispose of waste according to local, state, and federal regulations.
• Ensure that the laboratory equipment and instruments are in good working conditions to perform analytical testing and minimize down time.
• Collaborate with cross-functional teams to discuss stability concerns and address issues.
• Monitor, track, and publish metrics and react to key process performance indicators (KPI).
• Identifies areas for improvement and drives projects to implement solutions.
• Train and mentor chemists in the department for continued improvement in the areas of technical knowledge, productivities and regulations.

Qualifications

• 4-8 years of experience, preferred
• Bachelor’s degree in related field preferred or equivalent work experience.
• Experience with Quality Management Software (QMS), such as Veeva or Agile and compliance software like Laboratory Information Management System (LIMS), such as LabWare, preferred
• Prior experience leading a team of analysts and scheduling laboratory testing, preferred
• Experience with authoring standard operating procedures (SOPs), work instructions, and other documentation contributing to continuous improvement initiatives, preferred
• Strength in authoring and reviewing analytical method transfer, qualification and validation/verification protocols and reports, preferred
• Possesses working knowledge of USP, FDA, and ICH and ISO regulatory requirements as applicable to pharmaceutical stability testing, preferred
• Possesses a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures, preferred
• Experience with pharmaceutical testing techniques such as HPLC, UV-vis spectroscopy, Karl Fischer titration, and dissolution preferred