Assistant Manager

Purpose
The ‘Asst. Manager/ Manager – AD’ is a key member of the R&D team who be responsible to ensure the analytical development 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 development laboratory, looking after assigned projects & ensure compliance to timelines as well as scientific & regulatory principles.

Position / Job Title
Asst. Manager/ Manager – AD

Department
Analytical Method Development – 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 crossfunctional 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.