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JUBILANT DRAXIMAGE INC. DBA JUBILANT RADIOPHARMA, RADIOPHARMACEUTICALS DIVISION, is currently recruiting for a Process Development Specialist position to join our growing team!
What can we offer?
A culture that values opportunity for professional growth and development,highly competitive base pay, comprehensive medical, dental and disability benefits programs, group retirement savings program, health and wellness programs.
Jubilant DraxImage Inc. is a rapidly growing company with offices in Kirkland, QC and Yardley, PA. A global leader in the development of radiopharmaceuticals and state-of-the-art technologies, we are continuously seeking high caliber professionals to join our team. Jubilant DraxImage is a proud member of the Jubilant Pharma family. For more information, visit www.draximage.com
We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions’ through growth, cost effectiveness and wise investment of resources.
If you’re up for a rewarding challenge, we invite you to take the first step and apply today!
Jubilant Pharma Holdings Inc and all our subsidiaries proudly embraces diversity in our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We have an inclusive environment where our employees can thrive and where our differences are welcomed. By welcoming our differences, we create products that are beneficial for our patients, clients, and overall human health.Responsabilities:
- Assemble and lead the cross-functional product introduction and transfer team (R&D, Supply Chain, Manufacturing, Quality, Engineering, etc.) following development up to post-validation and commercialization.
- Develop detailed plan and prioritize the tasks in order to achieve project goals.
- Determine and manage project budget.
- Manage cross-functional teams, meetings and follow-up on actions.
- Deploy a systematic approach for product introduction via a stage gate process to assess the robustness of developed formulations and processes.
- Ensure product and process robustness and compliance.
- Emphasizes process control to enhance consistency and robustness.
- Support the implementation and extensive use of project management tools and processes, good engineering practices (GEPs), risk assessments (e.g. FMEA), continuous improvement and lean manufacturing techniques.
- Adapt R&D process to commercial equipment and capabilities when required.
- Perform Process Comparison Study.
- Responsible for ensuring the representativeness and the feasibility of the processes before the submissions lots.
- Provide support during the submission, engineering, and validation batches.
- Provide sound technical package for regulatory filing.
- Build and maintain extensive technical knowledge and expertise for some of Jubilant Draximage products (cold and hot products), processes and equipment.
- Writes SOPs, master batch records, and technical documents.
- Bachelor degree (Chemistry, Biochemistry, Engineering or related field).
- Minimum 5 years of experience in the pharmaceuticals industries with experience in a similar role.
- Good knowledge of GMPs
- Sound technical acumen, problem identification and solving capabilities
- Good analytical skills and detailed oriented.
- Proactive and result oriented.
- Excellent interpersonal skills and team work approach.
- Ability to work efficiently in a cross-functional team
- Good communication skills
- Autonomous and resourcefulness
- Ability to meet pre-established deadlines
- Proficiency in Word and Excel
- Proficiency in French and English (written and spoken)
- Project management certification an asset
Level of education
Work experience (years)
Fr : Advanced
En : Advanced
Fr : Advanced
En : Advanced
Internal reference No. Responsable, Développement de procédé...
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