Position Overview: We are seeking a highly skilled and experienced Senior Analytical Scientist (CDMO) to join our team at Candoo Pharmatech. The Senior Analytical Scientist will play a pivotal role in our analytical R&D and quality control processes. Report to QC manager, this position will involve in method validation, drug substance and product release, stability and troubleshooting activities in our upcoming CDMO facility. The successful candidate will collaborate closely with cross-functional teams to ensure compliance with regulatory standards and drive scientific excellence. Key Responsibilities: 1. Analytical Testing and Quality Control: \xc2\xb7 Perform routine and non-routine analyses using techniques such as HPLC, GC, dissolution, and spectroscopy.\xc2\xb7 Conduct prototype and GMP stability studies in accordance with ICH or other regulatory guidelines and assess product stability profiles. \xc2\xb7 Investigate out-of-specification results and implement corrective actions. \xc2\xb7 Collaborate with formulation scientists and regulatory affairs teams to support product development. 2. Method Development and Validation: \xc2\xb7 Collaborate with the analytical development team to transfer and validate analytical methods for new products or processes. \xc2\xb7 Participate in method development activities, optimizing and improving existing analytical methods. \xc2\xb7 Ensure that analytical methods are validated according to regulatory requirements, industry guidelines, and internal standards. 3. Team Management: \xc2\xb7 Has potential to lead a team of analytical chemists when required, providing guidance, training, and performance feedback. \xc2\xb7 Plan and prioritize work assignments, ensuring efficient laboratory operations and adherence to timelines. \xc2\xb7 Foster a collaborative and positive work environment, promoting continuous learning and professional development within the team. 4. Compliance and Documentation: \xc2\xb7 Ensure all analytical activities are conducted in compliance with cGMP regulations, SOPs, and applicable guidelines. \xc2\xb7 Draft GMP documentation such as test methods, material/product specifications, protocols, and SOP\xe2\x80\x99s as required. \xc2\xb7 Conduct OOT/OOS/Deviation investigations as required. \xc2\xb7 Promote and maintain a safe and healthy working laboratory environment in compliance with established health and safety procedures. \xc2\xb7 Maintain accurate and up-to-date laboratory documentation, including test records, reports, and laboratory notebooks. \xc2\xb7 Participate in internal and external audits, providing support and addressing findings related to analytical quality control. 5. Equipment and Instrumentation: \xc2\xb7 Perform and oversee the maintenance, calibration, and qualification of analytical instruments and equipment. \xc2\xb7 Evaluate new technologies and instrumentation, making recommendations for their implementation to enhance laboratory capabilities. Qualifications and Requirements: \xc2\xb7 Ph.D. or Master\xe2\x80\x99s degree in Analytical Chemistry, Pharmaceutical Sciences, or related field with minimum of 3 years or Batchelor degree with minimum of 5 years of working experience in the pharmaceutical industry.\xc2\xb7 Strong knowledge of analytical techniques such as HPLC, GC, dissolution, UV-Vis, FTIR , TOC, and titration. \xc2\xb7 Previous experience in a supervisory or team leadership role is preferred. \xc2\xb7 Proven ability to effectively manage a team, prioritize tasks, and meet deadlines. \xc2\xb7 Excellent problem-solving and decision-making skills, with the ability to troubleshoot and resolve analytical challenges. \xc2\xb7 Proficient in data analysis, interpretation, and trending using statistical tools. \xc2\xb7 Familiarity with chromatographic data acquisition software, laboratory information management systems (LIMS) and electronic document management systems. \xc2\xb7 Strong communication and interpersonal skills, with the ability to collaborate effectively across cross-functional teams. Job Type: Full-time Benefits:

• Company pension
• Dental care
• Extended health care
• On-site parking
• Paid time off
• RRSP match
• Vision care

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Mississauga, ON L5N 5L9: reliably commute or plan to relocate before starting work (required)

Education:

• Master\'s Degree (preferred)

Experience:

• Analytical / QC: 5 years (preferred)

Work Location: In person