The Position

Title : Specialist, Direct Materials

Division : Pharma Technical Operations

Primary Location : Mississauga

Duration : Regular Full-Time Role

Type : Individual Contributor Role

Roche is devoted to developing and producing medicines to treat patients with serious or life-threatening medical conditions.

The multi-award-winning company states its core purpose simply : Doing now what patients need next. It also embraces Roche’s three governing values of passion, courage, and integrity.

Pharma Technical Operations (PT) is the organization within Roche that manufactures and delivers its ground-breaking therapies to more than 120 million patients around the world.

PT are involved in producing every Roche medicine from the development process through clinical trials, and continuing through product maturity.

PT produces medicines at 15 plants and 11 sites around the world, coordinating all aspects of production in all disease areas and dosage forms.

We have manufacturing collaborations with 60+ CMOs in Europe, North America and the APAC region, 2600+ GxP Suppliers, app.

1500 Service Providers & 20+ out-licensing partners in worldwide locations.

Responsibilities :

Lead the execution of direct material-related operational and change management activities for the global Roche manufacturing network

Manage direct material (DM) introductions, changes, and qualification activities

Manage DM databases, documents, websites, and data repositories

Oversee DM-related material assessments, write protocols and reports, as applicable

Execute DM business process, develop process improvements solutions as needed, and guide alignment for the network

Work independently with limited direction and in a team environment with key customers / stakeholders including : Quality, Process Development, Manufacturing Sciences, Regulatory, and External Suppliers

Communicate effectively and efficiently with all levels of the organization

Identify and manage issues and conflicts in a positive manner

Present at department, cross department, and project team meetings

Create training materials and train stakeholders on DM business processes, tools, and requirements

Qualifications :

Bachelor's degree and / or advanced degree in Life Sciences or related field

A minimum of 5 years’ experience in biotechnology / pharmaceutical manufacturing, process development, and / or project management in a related industry

Familiarity and knowledge of cGMP and quality compliance

Knowledge of biomanufacturing processes and direct materials

Experience with Materials in Cell and Gene Therapy is a plus

Proficiency in Google applications gMail, gCal, gSites, gDocs, gSheet, gSlides)

Proficiency in Quality and Document Management Systems Veeva, Trackwise)

Experience with change management and project management preferred

Attention to detail and a desire to deliver high quality work

Ability to manage multiple tasks simultaneously and accommodate multiple priorities and timelines

Participate in teamwork at the network level and suggest project / process improvements.

Strong interpersonal, organizational, and problem solving skills

Flexibility and the ability to prioritize, multitask, and work with minimal supervision in a team environment

Ability to quickly synthesize information from multiple sources

Excellent written and oral communication skills in order to effectively and efficiently communicate in a global, cross-functional team setting

This position is not eligible for relocation support.