Job Description

Description :

This position is responsible for providing technical evaluation in terms of capabilities and costs for all Operational processes work required for the development of internal projects, for quotation of CDMO/CMO requests and other market extension or source change activities for all services provided on the Candiac site. The Technical Transfer Process Specialist will define the Operational strategy to deploy for the projects under evaluation and when required detailed the plan to introduce new services into the Candiac Business Framework. Multidisciplinary and creative, the candidate must be able also to provide input on the formulation activities for obtaining a robust formulated product in conjunction with the Formulation groups. Must be versed in the scientific methodology to appropriately challenge and guide all actions in obtaining a coherent and effective proposition meeting PMS objective and the customer requirement.

RESPONSABILITIES & DUTIES

• Coordinate the activities related to the costing of all operational processing for all projects to be completed in Candiac
• Identify the appropriate capabilities required for any project assigned to the site
• Coordinate the determination of all activities required for executing the identified processes in conjunction with the Operation and Engineering teams responsible.
• Obtain budget for all activities to be conducted thru outside partners.
• Establish in conjunction with PM high level timeline for all activities with Operation, Engineering and QA responsible parties.

• Coordinate the activities related to the costing of related Formulation work for all projects to be completed in Candiac

• In collaboration with the Pharmaceutical Development team, identify all activities required to obtain a robust formulation to be introduced into the site with no risk of rejects, and defects rate well within acceptable range
• Evaluate the various formulations developed by the pharmaceutical development teams and ensure coherence between the proposed formulation development and Operational process strategies.
• In collaboration with the Project Manager, elaborate optimal plan to satisfy/exceed customer expectation while providing the PMS team with a sensible project timeline.

• Activities for introducing new services in Candiac framework
• Coordinate the determination of all activities required for the establishment of a new service either in the Operation or in the Formulation areas on site
• Secure necessary partnership with external supplier to adequately positioned the site to render the new service
• Collaborate with the Project Manager and the Finance group to adequately update the Business Framework with the new service at the optimal price for the site

• Improve activities evaluation costing and estimates for Operational Processes and formulation work.

• Review tools and processes with the aim to improve accuracy for work estimates.
• Identify and implement new solutions to better predict risks and propose adequate mitigation plans.
• Participate in post mortem activities related to awarded proposals to understand areas of improvement, identifying major gaps in pricing or ineffective/inadequate clauses.
• Communicate with various internal departments as well as third parties during project execution to understand the teams risks/opportunities during project execution phase.
• Keep abreast with trends in CDMO/CMO space to anticipate industry orientation.

SKILLS, KNOWLEDGE & ABILITIES

• Respect company policies and directives
• Autonomous, in-depth multidisciplinary and leadership skills.
• Open-minded and collaborative with the ability to interact with tact and discretion.
• Agile and organised with the ability to handle changing priorities with short time lines while responding to new challenges
• Excellent communicator with the ability to easily integrate with diverse teams.
• Ability to transmit new ideas and approaches in a positive manner.
• Knowledge and ability to work effectively in French and English (written and oral)
• Expertise with the Operational processes and technologies required.
• Excellent knowledge of the pharmaceutical industry and cGLP/cGMP regulations.
• Ability to work with various software tools including Microsoft Office (Word, Excel), Microsoft Project
• Innovative spirit, inventive.
• Team spirit and adaptability.

Education : Bachelor
Bachelor

Experience : 0 years: 8 years pertinent experience with a BSc., 6 years with a MSc., and 4 years with a PhD . Previous CDMO quotation experience would be advantageous.

Pharmascience