Specialist, Technical Services
2 days ago
Making a difference, one role at a time._
Located in the heart of the Cité de la Biotech in Laval, Kedrion Biopharma Canada's mission is to make rare connections that impact millions of lives. Our team is developing an innovative treatment based on plasma-derived proteins, offering a new path of hope to children and adults suffering from orphan diseases. We're turning innovation into real solutions to save lives.
**More specifically, you will be responsible for**:
- Participating in process validation and preparing technical documentation in accordance with regulatory requirements
- Assessing risks to product quality for both current products and those in development
- Developing and supporting the preparation, execution, and performance reporting of pilot and engineering runs
- Acting as a person-in-plant to oversee outsourced technical activities
- Initiating and following up on change controls, deviations, investigations, and exception reports related to new or existing products and validation protocols
**You are the right person for this role if you have**:
- A Bachelor’s degree in biochemistry, biology, chemistry, or process engineering with a minimum of 7 years of experience, or a Master’s degree with at least 5 years of relevant experience
- Relevant R&D experience in biologics or biotechnology-derived products
- Experience in the development of technical processes for biologics or analytical assays
- Strong knowledge of quality risk management tools (e.g., FMEA, HACCP) and regulatory guidelines (Health Canada, FDA, ICH, EU)
- Excellent command of English (spoken and written) and spoken French
- Ability to work independently and collaboratively within cross-functional teams, with rigor and strong organizational skills
**Prometic offers you**:
- A fantastic team that strives to do things in the best possible way;
- A relaxed working environment;
- A start-up culture that values autonomy, innovation and collaboration;
- A competitive salary and benefits package;
- A unique opportunity to change lives through your commitment and contribution.
- Knowledge of French is required for positions permanently located in Quebec so incumbents can communicate with their colleagues and suppliers in Quebec as necessary._
- Other language requirement_
- Another language is required for this position in order to communicate with partners and colleagues, who are predominantly located outside Quebec and to understand the technical and scientific documentation used in our industry._
- Kedrion Biopharma Canada is committed to equal employment opportunities._
**_
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