Manager/Asst.Manager- Analytical Development

Purpose The ‘Asst. Manager/ Manager – AD’ is a key member of the R&D team who be responsible to ensure the GMP analytical activities for the assigned projects are carried out in a timely manner as per organization needs. This would be a managerial role who would be independently ensuring the functioning of the Analytical GMP laboratory, looking after assigned projects & ensure compliance to timelines as well as scientific & regulatory principles. Position / Job Title Asst. Manager/ Manager – AD Department AD – R&D Reporting To Sr. Manager – Research & Development Location Concord - Canada Years of Experience 15+ years Dosage Form Nasal / Liquid Job Responsibilities / Deliverables - Ensures that the Analytical Methods are Developed and Validated as per the requirements for the products identified. - Mentor the lab personnel to carry out Analytical Testing and reporting as required to facilitate the submission of dossiers to the regulatory authorities and technology transfer to the identified Contract Manufacturing laboratories - Ensures that methods developed are suitable to meet international regulatory requirements and are in conformance with the protocols and practices of the Rubicon Analytical and Quality Systems. - Will strive to meet the Quality and Timeline Goals required for the timely completion of the project along with other team members of Analytical, Formulation Development, and Project Management teams. - Ensures that appropriate co-ordination is achieved with external Laboratories, vendors and other sources required for the timely completion of the identified projects. - Implements and assists the Analytical team to build capabilities and processes that facilitate analytical excellence and best practices for the identified projects, processes and techniques - Liaises with cross functional team counterparts to harmonise the timely development of products for Rubicon. - Collaborates with regulatory and local R&D teams to contribute towards the regulatory dossiers. - Lead analytical activities & mentor junior lab personnel to ensure smooth & efficient working of the analytical lab - Maintains in-depth knowledge of current analytical and best quality practice requirements to provide execution, documentation and technical input to teams during product development. - Participates in GMP audits of contract manufacturing and testing sites in the capacity of an Analytical SME - Participate in review meetings to update upper management regarding project progress - Prepare material budget for projects - Participate in hiring process for lab personnel. - Ensures execution of analytical work, writes and peer-reviews work done by analytical team members, including analytical documentation from internal and external sources to ensure compliance/alignment with analytical methodology required. - Develops and facilitates excellence in key areas required for Analytical Development towards the identified product development requirements of RRCL. - Plays a proactive role in the analytical team to achieve teams’ goals - Participates in inspections and audits as a SME for identified products, processes and technologies - Assists the Analytical team to manage equipment calibration schedule and review of calibration records for identified instruments and equipment - Participates in Training and updates team members of identified on analytical and current regulatory policies and procedures - Qualifications & Pre-Requisites - Masters degree or equivalent in an applicable discipline of science (pharmaceutical sciences, chemistry, biochemistry, chemical engineering, medical laboratory science or related) - 15+ years of experience in a pharmaceutical R&D laboratory and / or CMO setting - Experience in development of formulations in solutions/ semi-solids/ suspension dosage forms - Exposure in development and characterization of nasal / inhalation products will be an asset Role requires independent working with minimal supervision. - Candidate must be motivated and capable to handling independent projects - Good written and oral communication skills Additional notes - Role may be required to work in afternoon shift (12 pm to 8 pm) on a need basis. - Expected to travel overseas / within Canada on a need basis to manufacturing facility(ies) to participate in Technology transfer of products.