EDUCATION AND EXPERIENCE REQUIREMENTS:

• Canadian equivalent to Master of Science, PhD or Bachelor of Science degree, preferably in Pharmacy, Chemistry or
• Pharmaceutical Chemistry.
• More than three years of relevant hands on pharmaceutical experience in product development. Demonstrates knowledge and experience of analytical chemistry by developing analytical methods such as assay, dissolution and related substances. Understanding of DOE, risk based assessment tools, quality by design, method validation, equipment troubleshooting and technical transfer. Experience with Chromeleon software is preferred.
• Demonstrated ability to work independently or as a part of a team, and to coach less experienced colleagues.
• Highly motivated and have the skills to handle multiple projects and prioritize the work.
• Excellent communication skills (oral and written) and interpersonal skills are required
  Job Types: Full-time, Permanent
  Pay: Up to $66,000.00 per year

Benefits:

• Casual dress
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Flexible schedule
• Life insurance
• Paid time off
• RRSP match
• Vision care

Application question(s):

• Do you currently reside in the GTA?

Education:

• Bachelor’s Degree (required)

Experience:

• relevant Canadian Industrial Pharmaceutical: 3 years (required)

Work Location: In perso

• Responsible and accountable for supporting the Analytical Development Scientist in designing, planning and executing all aspects of assigned projects through scientific rationale using Quality by Design principles to develop new products per departmental SOP’s and ICH guidelines. This should be done in consultation with senior peers: Analytical Development Scientists, Manager or upper management.
• Applies analytical/problem solving skills and utilizes available resources to identify process and/or formulation deficiencies and propose solutions to be implemented. In addition to working with more experienced colleagues to troubleshoot and resolve challenges during the development of analytical methodologies.
• Supports writing the summary of pharmaceutical development reports including analytical method development, method validation, related substances identification, force degradation studies, stability reports and all other information required in the CMC sections of CTAs, NDS and S/NDS, in a timely fashion. Furthermore, provides the required information to support FDA, EMEA and ANVISA submissions.
• Supports internal projects and external Contract Manufacturing Organization projects in alignment with Biolab’s objectives and initiatives. Communicates/interacts as indicated by management with QC/Contract Laboratory during transfer of analytical methodologies from R&D in a timely fashion.
• Collaborates with regulatory documents, and team efforts to define formulation, manufacturing process and drug product specifications.
• Ensures all analytical activities meet good laboratory practices and company’s policies.
• Ensures the availability of chemicals, reagents, apparatus, HPLC columns, solvents, etc. needed to carry out all task in the analytical development area.
• Performs data collection and analysis, discuss conclusions regarding progress of work, and effectively communicates information to peers and management in the form of presentations and reports.