Manufacturing Lead – GMP Cellular Therapy

November 9, 2021 Manufacturing

Job Overview

Job title: Manufacturing Lead – GMP Cellular Therapy

Job description: Reporting to the Manufacturing Manager, the Manufacturing Lead is part of the Cellular Manufacturing Unit of our client – the most advance production team of cells therapies in Canada, located in a state-of-the-art cGMP facility.
The Manufacturing Lead acts as the product/process owner of the sponsor’s product. Is responsible for the project specific qualification of the production team. Is responsible for the coordination of the production teams -Manufacturing Specialists and Manufacturing Technologists. As well, is responsible for answering the scientific questions of the sponsor on the performance of its product. Responsible of supervising the execution of the work needed as well as evaluating the needs (HR, material, equipment, time).

This position will support process tech transfers, cGMP production activities, and technology improvements towards the successful delivery of released product to meet the needs of a client’s clinical trials.

Responsibilities

Manages tasks and resources for their specific product/project backlog required for the manufacturing of cell therapy products including scheduling & staffing production according to Master Production Plan.
Provides technical expertise for troubleshooting manufacturing issues and act as process and equipment subject matter expert (SME).
Participates in manufacturing meetings with the sponsor and serve as the key technical and scientific production specialist.
Creates and develops batch record documentation, SOPs, BOMs, Tech Transfer documents, including writing and reviewing production reports.
Conducts the technical and scientific part of complex investigations and CAPA to ensure product quality and patient safety.
Ensures with the Project Manager the follow up of the deviation and change controls document to insure proper integration of the process modifications.
Implements and maintains manufacturing processes for new and/or existing products and technologies in a cGMP environment.
Supports technology transfer and cGMP production activities and provide technical expertise for troubleshooting manufacturing issues.
Integrates best practices, where appropriate, into manufacturing.
Ensures the appropriate verification and maintenance of equipment before each production.
Uses a proactive and organized approach to accomplishing deliverables.
Collaborates with other departments to develop and optimize early phase processes/ Identifies and implements continuous improvements.
Guides and coordinates with logistics team all areas of cell culture, including inventory management, shipping, and reception of cell products specific to project.
Responsible for filling out the project specific documentation for shipping.
Coordinates with the logistics team, the production’s team availability to support logistics tasks.

Team leader:

Support production in cleanroom if necessary and communicates product status to appropriate stakeholders (PM, QA/QC, Analytical Development, sponsor)
Coach the Development Team in the cGMP environment
Train and mentors manufacturing personnel
Enhance and increase teamwork and personal involvement, encouraging, enabling and energizing people and helping them to realize their potential.
Ensure that goals, scope and product domain etc. are understood by every team member
Help the team understand the need for clear and concise product backlog items.
Ensure that employees are working in a safe and compliant manner

Requirements, Knowledge, Skills and Abilities

Master’s in Biology, Chemistry, Engineering or combination of BSc/TM

o Manufacturing lead: Over 5 years of experience in Cell culture and 2 years of experience in Cell Therapy cGMP environment
o Senior manufacturing lead: Over 10 years of experience in Cell Therapy and 5 years of experience in cGMP environment

Experience in a similar leadership position is an asset
Ability to follow verbal and written instructions
Problem Solving skills
Detail-oriented
Team player
Strong communication skills
Strong demonstrated aseptic techniques
Ability to experience extended periods of standing (8 hours)
Flexibility to work weekends, overtime hours, and some holiday work as the case may arise
Must be able to work in controlled environments requiring special gowning.
Bilingualism in English and French, oral and written.

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Company: Groom Associes

Expected salary:

Location: Montreal, QC

Job date: Fri, 08 Oct 2021 05:15:16 GMT

Job Source: Careerjet.ca