Technology Transfer

• Maintain continuous contact with the clients, focusing on the clients' requirements.
• Generate key documentation including the Technology Transfer Checklist, Gap Analysis that includes process design, Technology Transfer Master Plan/Scope, Technology Transfer Report, Project Timeline and Action Item lists.

Project Management

• Identify key collaborators for client requests and lead discussions to provide solutions.
• Lead, track, follows up and supervise project activities to ensure alignment with expectations and agreed-upon timeline.
• Oversee planning, execution, and closure of all Engineering/Feasibility/Optimization phase activities.
• Chair regular meetings and correspondence between internal and client teams.

Process Optimization

• Maintain document/information repository.
• Contribute to the optimization of the production process, with continuous efforts to increase project savings on the technical side, while maintaining compliance with cGMP and company procedures.

Risk Management

• Proactively identify, evaluate, and mitigate risks to project timeline or commercial production.
• Liaise with the Technical Operations to fully understand scope and of projects triggered by events on existing commercial products.

PDS Relationship Management

• Work closely with Pharmaceutical Development Services (PDS) formulator to follow and understand early-stage product development for PDS-to-Commercial product transfers.

Internal Support and Client Relations

• Provide support to all company functions throughout the course of the project.
• Provide support as needed to Potential and existing clients until time of transfer from the client to Thermo Fisher.
• Champion positive and collaborative work environment.

GMP & Health & Safety:

• Ensure cGMP is applied in work area and follows cGMP in all areas of the business.
• Understand and apply as needed, emergency procedures and safe systems of work.

Evaluation of the Technical Costs

• Support the Commercial Quotes Group with the evaluation of the technical costs of the new job orders, providing the material technical details, production schedule, processes, and supply costs, aligning with the interests of the company.

REQUIRED QUALIFICATIONS

Education:
Bachelor's degree science, engineering, pharmacy, or business.
Project Management Professional (PMP) certification is an asset

Experience:
Minimum 5 years' previous experience in Engineering, Productions, Quality, or relevant contract manufacturing environment.
Minimum 3 years project management and/or client service experience.

Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities:
Strong communication skills. Strong Project Management skills including keeping client relationship on track and mend difficult relationships. Commercial business orientation and financial competence. Strong knowledge and understanding of manufacturing/operational processes. Excellent knowledge of Good Manufacturing Practices and Food and Drug Administration (FDA) compliance knowledge. Effective social skills, and the ability to collaborate with influence and empower cross-functional team members. Ability to meet timelines and prioritize multiple project results. Well organized with strong attention to detail. Ability to work both in a team environment as well as independently as required. Proven computer proficiency with Microsoft Office programs and database management skills. Proficiency with the English Language.

Standards and Expectations:
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to quality SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

Physical Requirements:
Light physical effort and fatigue. Walks, sits, or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.