R&D Technology Transfer Specialist
Title: R&D Technology Transfer Specialist
Location: Montreal, QC
Permanent, full time position
Salary: Competitive + benefits
To apply: Please send your CV to Sarah Groom - email@example.com
The R&D Technology Transfer Specialist will assist and support the successful transfer of new products to the CMO, from R&D level to commercialization, and developing manufacturing/packaging processing for proprietary products. Responsible for site-transfer projects, designing and managing tech transfer protocols, product improvement activities, technical support regarding source, site changes and for products already on the market (manufactured at CMO’s). The candidate will communicate heavily with CMO’s as well as other functional teams leading to effective resolution of any issues.
If you are an enthusiastic self-starter, goal driven, love R&D and have an interest in the pharmaceutical industry, then we are looking for you!
•Assist in setting up NDA and technical agreements with CMO
•Discuss project details with manufacturer and visit manufacturer to evaluate manufacturing capabilities or to validate manufacturing process when required. Team up with quality team for cGMP audits
•Provide technical summaries at key stages of technology transfer process, work closely with Manufacturer and formulators to deliver successful processes for production of MEDISCA’s drug delivery base vehicles
•Support design of experimental studies intended to provide supporting data or to resolve technical issues encountered during a project
•Support technical support services in resolving technical issues and drive the completion of investigations that affect the technical scope, make recommendations for various options that would resolve the issue.
•Clearly and accurately document activities
•Collaborates with R&D formulation team regarding the design and execution of lab, pilot and commercial process parameters, master batch record writing, specifications, verification and approval of tech transfer protocol from CMO, batch execution, post batch evaluation and analysis
•Review batch records, investigation reports, change controls, market complaints, validation documents, equipment qualification reports, technology transfer dossiers, stability data, raw material data trend, and CAPAs, in process and finished product analytical data
•Prepare and review PPQ (Process Performance Qualification) reports, issue change request through quality management system and support validation process
•Understand and apply all aspects of cGMP requirements and recommendations from many different regulatory agencies as they pertain to the technology transfer of products and processes
•Perform process improvement projects and troubleshoot production processes
•Develop, review and maintain Policies and Procedures that describe the various steps necessary in transferring products
•Assist Operations, Quality and Regulatory Affairs department with technical questions related to products
•Designs, conducts, and coordinates scientific studies for physical/chemical characterization, API compatibility, stability testing, packaging compatibility
•Executes experiments at lab scale and commercial scale to implement the use of quality by design (QbD) principles to develop robust process parameters
TRAVEL: Travel required visiting/auditing CMO or supplier, attending seminars either locally or internationally, when needed (25% travel)
•Basic knowledge of GMP standards, ICH/FDA/Health Canada regulations
•Excellent communication skills; fluent English and French ( oral and written) required
•Office (Word, Outlook, Excel, and PowerPoint) required
•Demonstrates integrity and willingness to comply with all regulations, policies, and SOPs
•Works independently with minimal supervision
•Demonstrated ability to work in a team environment and display initiative
•High degree of professionalism, accountability, and ethics
Required Experience•Three (3) to five (5) years’ related experience and/or equivalent combination of education and experience in Pharmaceutical Sector/ Manufacturing /Process Development/Tech transfer/Validation
•Bachelor’s degree in a Science related field (Chemistry preferred)
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