The Analytical Development Manager is responsible for the supervision, guidance, mentoring and coaching to less experienced personnel when conducting technical activities to develop, validate and transfer new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by using knowledge and innovation of science, technology and chemistry to investigate the properties, components and abilities of chemicals and processes in the development of efficient manufacturing procedures and the development of appropriate analytical methodologies to create prototype formulations and clinical supplies as per assigned projects by upper management to meet company’s goals within the specified timelines. This position also requires documenting, reviewing, analyzing and interpreting data, and interpreting complex problems in support of HC, FDA, EMEA and ANVISA submissions in a timely manner while complying with departmental SOP’s and guidelines set out by the regulatory agencies and ICH (International Conference on Harmonization). This will be achieved by working very closely with the formulation development and R&D QA teams.
Key job responsibilities and duties:
• Responsible for leading analytical research related functions to meet project timelines, focusing on product specific release and stability indicating tests such as assay, dissolution and related substances, including method development, method validation, equipment qualification, technical transfer, and troubleshooting.
• Provides direction and daily operational support to everyone in the analytical development team. Also, provides technical and organizational leadership in alignment with Biolab’s objectives and initiatives.
• Authors/reviews regulatory documents, and lead efforts to define drug substance and drug product specifications. Additional responsibilities might include improvement of methods for existing products.
• Responsible for conducting scientific research for the development of in-vitro analytical techniques to support innovation, expedite the development process of new products and reduce development cost.
• Responsible for monitoring stability programs as per ICH conditions to meet ANVISA, FDA, HC and EMEA.
• Plans, assigns, directs and coordinates work. Ensures deliverables and quality standards are achieved. Prepares and conducts performance evaluations for employees.
• Performs data collection and analysis, discuss conclusions regarding progress of work, and effectively communicates information to Management in the form of presentations and reports.
• Responsible and accountable for compliance with all aspects of the Ontario Occupational Health and Safety Act, as well as Biolab’s Health and Safety policies.
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 ten years of relevant hands on Canadian pharmaceutical experience in product development.
• Must have in-depth knowledge of analytical chemistry and/or organic chemistry.
• Strong working knowledge and proficiency on analytical method development.
• Thorough understanding of analytical equipment, such as GC, LC/MS, HPLC, UV and automated dissolution systems is essential.
• Experience with design of experiments, six sigma methodology, risk based assessment tools, quality by design and Chromeleon software is preferred.
• Demonstrated ability to lead teams of 15 people minimum
• Highly motivated and have the skills to handle multiple projects and prioritize the work.
• Excellent communication skills (oral and written) and interpersonal skills are requiredApply Now