Main responsibilitiesCoach, guide and motivate reporting team to achieve high quality and original results in an effective manner.Monitor, measure and optimize analytical research tasks cycle time.Implement new programs and technology within analytical research to meet technical requirements of the CMCs, QbD and IP.Work closely with Analytical and Biotech Process development teams leaders/supervisors in maintaining uniform personnel practices, work assignments standards and development efficiency.Contribute to efficient design of experiments in all Analytical research work conducted by the reporting team.Set up and maintain clear and transparent work reporting system and matrix for all analytical development work.Ensure effective data review process, timeliness and assignments in the activities within the area of responsibility.Harmonize analytical research, planning and matrix between company international sites and beyond as required.Ensure timely completion of projects based on defined deadlines.Ensure that all work and obtained data meet required level of quality and adherence to GLP (where applicable), and company SOPs as needed.Maintain safe working conditions.Motivate team members to high performance and work standards and practices.Be able to interact with reporting and beyond reporting team to strengthen collaboration with analytical and biotech process development team and beyond.Coach team members and author effective writing of SOPs, procedures,business and costing justifications and presentations as necessary.Interact and liaison with other Departments within company R&D and Commercial Area as well as International sites as required.Assess and conduct annual performance reviews.Participate in other (i.e.
administrative) activities of the Department, as requested.
Requirements Minimum M.Sc.
degree in Biology, Biotechnology or Pharmaceutical technology combined with ten (10) years of pharmaceutical/analytical laboratory experience in the leadership or equivalent capacity.
degree in Biological sciences combined with five (5) years of pharmaceutical/analytical laboratory experience in the leadership or equivalent capacity are preferred.Superior knowledge of biochemical/biological as well as physico-chemical techniques including but not limited to electrophoretic methods, eucaryotic cell line culture and bioassays, HPLC, mass spectrometryDemonstrated leadership skills - ability to effectively communicate, motivate employees and obtain results in a team-based environment.Demonstrated ability in effective planning and on-time delivery of tasks with expected quality outcomes.Thorough familiarity with GMPs, GLPs and company SOPs.Familiarity with relevant EMA/FDA/ICH/TPP guidelines.Good interpersonal skills.Good organizational skills combined with strong logical thinking ability.Excellent written and verbal communication skills, ability to communicate and work effectively in a team-based environment.Computer literacy with relevant software.