Manager, Analytical R&D (Lab Automation)

Job Summary

Responsible for directing the staff and activities of Analytical Research & Development To develop testing methods for drug substance and drug product.  Advices the Product development group in the development of products through a thorough understanding of the chemistry of molecules in products and its behaviour in different dynamic environments.  Organizes, coordinates and oversees NPD process in the team-based environment, provides technical guidance to senior scientists/chemists, implements team-oriented approach from the earlier stages to completion of the project. Evaluates technical data and decides on course of action during NPD process. Ensures quality of the newly developed analytical methods and regulatory submission documents.  Reviews/approves new product specifications.   Provides expert advice to Formulation Development Department on critical quality attributes such as stability, compatibility, dissolution, and solubility to optimise and facilitate formulation development.  Establishes close working relationships with other Product Development departments to create an integrated research environment and to ensure timely completion of NPD related submission documents for RA.  Lends expertise to other areas within the Apotex organization.  Assists Director in strategic planning, budgeting and staffing.

Job Responsibilities

• Plans, organizes and oversees the activities in the Analytical  R & D Team.
• Manage effective method development and validation activities in the area of lab automation
• Provide recommendations to the management on enhancing productivities by using advanced lab automation equipment.
• Reviews and approves regulatory submission and other technical reports generated by the Analytical Development Team. Ensures the quality of documentation and test results generated in the AD.
• Monitors the quality and productivity of the lab output to ensure that optimum levels are achieved. Makes recommendations to the Director for continuous improvement of lab operations.
• Coordinates AD lab activities with those of other Analytical units
• Liaises with the Formulation Development Department and provides input to the formula development process as related to drug product compatibility, stability and dissolution/drug delivery characteristics.
• Works closely with other units of Analytical Operations, provides expert advice to other members of the AO team.
• Liaises across the organization at all levels to provide an in-depth level of expertise.
• Makes presentations at the executive level to keep them current with research and project development.
• Liaises with relevant laboratories to ensure timely physical testing of pharmaceutical samples.
• Investigates, encourages and uses unique problem solving techniques to perform trouble-shooting on highly complex issues with respect to the stability of drug substances and drug products, compatibility of API and excipients, chromatographic methodology.
• Lends expertise to other Analytical groups for the resolution of more complex technical issues to ensure a holistic approach.
• Recommends strategy and action plan with respect to new technology to Director, Analytical Development.
• Continuously upgrades knowledge in pharmaceutical chemistry through review of scientific literature, attendance of training courses, and professional conferences.
• Ensure proactive performance management of self and the team through regular performance discussions, annual performance reviews and career development.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process. 
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures. 
• All other duties as assigned.

Job Requirements

Education
•    Bachelors in Scientific discipline especially Organic Chemistry or Analytic Chemistry or pharmaceutical sciences.  Masters or Ph.D. preferred.

Knowledge, Skills and Abilities
•    Advanced knowledge of analytical, organic and solid-state chemistry, pharmaceutical solid dosage forms.
•    In depth knowledge of regulatory guidelines (FDA, TPD, ICH etc.)  GMP and GDP.
•    Excellent written and verbal communication skills.

Experience
•    7+ years of pharmaceutical industry experience with demonstrated achievements in pharmaceutical R&D with focus on analytical research.
•    Expertise in Drug substance and Drug product testing methods development.