Scientific Leader, Analytical Development

Job Summary

Responsible for developing, validating and applying analytical methods in compliance with current compendial pharmacopoeias, ICH, SOP and GMP requirements; testing and evaluation R&D samples in support of selection of API suppliers, specification development and NPD process; providing scientific support to Product Evaluation, Formulation and Process Development departments. Possess in depth knowledge of organic/analytical chemistry applied to pharmaceutical development. Serve in both capacities– as a supervisor and project leader. Schedule, assign, and provide assistance and supervises projects. Perform most complex tasks and high priority special projects. Responsible and accountable for compliance with all aspects of the Ontario Occupational Health and Safety Act, as well as Apotex’s Health and Safety policies, Safe Work Procedures (SWPs) and Safety Charter.

Job Responsibilities

• Recruit, train, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:
  • Ensuring their Job Descriptions are reviewed, signed and sent to Employee Services, annually,
  • Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties,
  • Providing coaching, feedback and recognition.
• Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies.
• Schedule departmental projects in consultation with AD manager. Assign projects and tasks to individual chemist taking into consideration of their accountability profile.
• Supervise and provide technical leadership for project and undertakes accountability for project milestones.
• Approves validation protocols.
• Release methods, validation reports and certificate of analysis for auditing. Clarify and respond to any concerns during data review.
• Ensure all instruments within group/department are well maintained and shared by the chemists.
• Provide the information the group needs to know to do their jobs and feel good about being a member of the team, unit and/or organization.
• Monitor process, progress and results; prepare monthly and project progress reports. Concentrate his/her efforts on the more important priorities.
• Delegate activity and responsibility to chemists while retaining overall responsibility and accountability for performance.
• Perform all activities in compliance with SOP’s and GMP, meeting all established regulatory, compliance and safety requirements.
• Carry out all work in manner which is consistent with Apotex’s policies. Acts at all time in the interest of Apotex.
• Maintain accurate and complete records as per SOP on all analysis performed and prepares analytical reports.
• Ensure analytical methods validation is conducted according to approved validation protocol in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines.
• Assist in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP.
• 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; 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
  • Strong theoretical background, PhD or MS or BS degree in chemistry or related field paired with a good understanding of organic, physical and analytical chemistry
• Knowledge, Skills and Abilities
  • Work as a member of a team to achieve all outcomes.
  • Able to work on multi-projects simultaneously while producing high
    quality work.
  • Computer literate. Advanced knowledge of chromatographic instrumentation and data systems
  • Possess exceptional organizational skills.
  • Possess advanced knowledge of the instrumentation such as HPLC, GC and IC, including Chromatographic Data Systems. Knowledge of UV, IR, and Wet Chemistry.
  • Demonstrated proficiency in written and verbal English communication
• Experience
  • 3-5 years (PhD) or 6-9 years (MS) or 10+ years (BS) of R&D experience, preferably in the pharmaceutical industry.
  • Extensive knowledge and experience in analytical chemistry.