In an effort to continue their leading status of innovation and development, through Four Corners Group, Trudell Medical International is now seeking a Group Director, Science & Technology.
THE ROLE
This position will be responsible for providing strategic, technical, and managerial direction to all science and technology departments with a specific emphasis on product development and innovation. The individual in this role will demonstrate dynamic and energetic leadership that emphasizes new product development and strengthens TMI’s intellectual property portfolio; create an exciting environment and a contagious level of enthusiasm that encourages innovation and improves employee engagement; improve overall time to market; act as a technical resource to scientific and technological staff members; support TMI’s business development initiatives; and represent the company externally at various industry functions.
MAJOR RESPONSIBILITIES
Strategic Direction:
• Continuously advance TMI’s product development, science, and technology activities
• Promote innovative design and development of products
• Maintain regular and ongoing communication with the VP/GM on planned activities, results, opportunities and competitive information
• Work as an active member of senior management and as a member of management teams responsible for the success of the organization
• Ensure budgets, financial and management reports are accurate, informative, timely and complete including Monthly Operating Comments
• Establish business objectives for product development, science, and engineering departments, and ensure cascading of them to departmental and staff levels
• Establish business plans for product development, science and engineering departments
• Establish budgets for product development science, and engineering departments
• Improve TMI’s intellectual property position
Technical Support:
• Ensure accuracy and completeness of SOP documentation preparation
• Ensure cooperation with Regulatory Affairs staff to provide accurate and complete submissions to national and international regulatory bodies
• Ensure provision of technical assistance to production personnel; TMI and interdivisional Sales and Marketing staff; vendors; and, within product development, science, and engineering departments
• Ensure provision of external customer service support, e.g. responses to technical enquiries with written technical briefs or presentations to customers; creation of customer documentation for new products; interfacing with potential customers
• Ensure provision of support to vendors, i.e. during selection and approval process for components for developmental purposes
People Management:
• Assist in the hiring, development, motivation and retention of qualified staff who will assist TMI in achieving its goals
• Administer policies and procedures which ensure employees are treated fairly and equitably, have a sense of self-esteem and are encouraged to maximize their full potential
• Assist in the development and progress of employees by formally evaluating their performance, based upon mutually established objectives, once per year at a minimum and optimally, once per quarter
• Ensure employees are trained in approved work procedures to obtain optimal output without accident and injuries and ensure that employees follow safe work methods and all related standards
• Effectively direct and provide leadership to each business area of responsibility, through the development of each team member
• Recommend best business practices, monitor performance and ensure effective communication to departmental personnel
• Coach, develop and mentor employees to succeed in achieving business and professional objectives
• Ensure a development plan is created and followed for all staff
New Product Development:
• Take action to be at the lead of new product development by establishing and maintaining an active network of science, engineering, pharmacology, chemistry, and life sciences experts; establishing and maintaining an active catalogue of science, engineering, pharmacology, chemistry, and life sciences resources; and, reviewing literature for future product ideas
• Source and attend, or facilitate TMI staff to attend, conferences and tradeshows that provide new learning opportunities for potential product or technology innovations
• Identify innovative product and technology opportunities and direct internal resources accordingly
Continuous Improvement and Knowledge Management:
• Ensure application of best practices in process development and laboratory management
• Ensure the creation and development of custom test apparatus for the evaluation of TMI and competitive products
• Contribute to and direct areas of focus for TMI authored abstracts and publications
• Direct areas of focus for TMI presentations; present TMI abstracts and publications to support new or existing products
• Ensure awareness and exploitation of intellectual property (IP) requirements and competitor IP details
Policy and Regulatory Compliance
• Adhere to and enforce all relevant policies, procedures and legislation, including Good Manufacturing Processes (GMPs) and Good Laboratory Practices (GLPs)
• Comply with and enforce product development procedures
• Ensure documentation of new ideas in TMI engineering log book and maintenance of log book in accordance with TMI’s Inventions Policy and Procedures
• Ensure design development activities are carried out in full accordance with TMI’s Quality Policy and Procedures, including relevant SOPs
• Ensure the creation of complete specifications, including product design and component, assembly and detail drawings, DFMEA, Moldflow analysis and bills of material
• Ensure the products are developed to meet all regulatory requirements including design controls
• Ensure the preparation of patent invention disclosures and provide technical assistance during patent application process and patent analysis
• Ensure complete and accurate reporting to maximize SR&ED tax credits
Health and Safety:
• Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
• Ensure establishment, maintenance, and adherence to Good Laboratory Practices (GLPs)
CANDIDATE QUALIFICATIONS
The Group Director, Science & Technology will be a natural leader who has the ability to drive change and make decisions while also nurturing a collaborative environment that thrives on innovation. A consummate professional, the individual will bring a track-record of demonstrated success in product development and will be a key factor in the company’s future growth.
Candidates will have:
• Advanced degree in science, engineering, pharmacology, chemistry, life sciences, engineering or a related field;
• Fifteen years of progressive experience in the pharmaceutical and/or medical device or related industry;
• Understanding of aerosol drug delivery systems and knowledge in applicable disciplines, e.g. mechanical engineering, aerosol science, etc.
• Ability to develop and maintain strategic and effective working relationships, with excellent leadership and motivational skills, and the ability to translate strategic direction into work plans and projects;
• Knowledge of regulatory requirements applicable to new product development such as ISO Design Controls, FDA, GMP, and HPB;
• Knowledge of clinical research processes and exposure to clinical use of products
• Demonstrated technical knowledge as evidenced in peer reviewed publications
• Superior written and oral communication skills;
• Computer literate with advanced experience in MS Excel, database packages, internet information acquisition, graphical presentation packages, and mathematical statistics software; and, intermediate experience in MS Word, and MS Project Management;
• Commitment to highest standards and continuous improvement
• Ability to travel internationally
LOCATION
This position is based in London, Ontario with an approximate 5-10% travel requirement.
Qualified and interested candidates are encouraged to send a resume to:
anorrie@fourcornersgroup.com.
