Responsibilities include, but are not limited to :
Participate in the design, planning and implementation of clinical trials.
Develop and ensure adherence to clinical trial timelines.
Prepare, review and approve trial-related documents.
Manage and oversee clinical activities from the start-up to the completion of the trials.
Ensure proper communication of study progress to stakeholders.
Identify, lead and manage CRO and other vendors.
Responsible for the quality and compliance with protocols and study procedures and ensure audit readiness.
Collaborate in the development of clinical SOP and guidelines.
Communicate and support clinical investigators.
Participate in the Site Initiation Visits and oversight of CRAs activities.
Coordinate and manage the Investigational Product and clinical samples operations.
Participate in the analysis of clinical trial results.
To be considered for this role, you must possess the following minimum qualifications :
Masters degree in biological sciences
A minimum of 3-5 years experience in clinical development with a minimum of 2 years in the management and coordination of clinical trials.
Strong understanding and knowledge of GCP and ICH guidelines.
Experience with CRO and vendor selection (RFP, Bid Defense) and management.
The ideal candidate will possess :
A Ph.D. in biological sciences
5-10 years experience in clinical development with a minimum of 2 years in the management and coordination of clinical trials.
Required Skills :
Strong negotiation, communication and organization skills.
Detail oriented and ability to prioritize.
Show adaptability and empowerment.
Capacity to work under pressure and tight timelines.
Work on several different projects and able to perform key responsibilities in a fast-paced, as well as in a team environment.
Develop robust formulations processes for lipid based protein / peptide sterile parenteral dosage forms
Write study proposals, execute experiments, prepare batch records and process development reports
Support scale-up and optimization of existing manufacturing process; technology transfer from R&D to production to meet timelines.
Provide technical information for the generation of change controls, change management, design, and implement changes.
Participate as author for process transfer documentation, technical reports, batch records, GMP documentation and regulatory filings.
Plan and contribute to project-related scientific / technical activities (e.g., critical interpretation of data, write reports and presents work at group and department meetings)
Author or support technical documents writing / review for tech transfer to CMOs and for regulatory filing purposes.
Interact with API manufacturers, equipment vendors, CROs and CMOs as needed.
Maintain instruments, qualification / validation of critical GMP equipment, troubleshoot instrumental / experimental problems and order / maintain supplies.
Generate and update SOPs, review of batch records, process characterization reports, validation reports and investigation reports.
Monitor process performance; implementation of process improvement strategies; development of process models.
Provide process development expertise for clinical / commercial Drug Product processing in specific areas such as Sterile processing, Process Characterization, Tech Transfer and Validation.
Support commercial DP manufacturing operations with technical evaluation of NC / CAPA, scale up, validation, and technology transfer.
Troubleshoot issues with DP processing technologies and equipment. Conduct FMEA for DP operations and propose / implement appropriate CAPA.
Identify and implement operational opportunities for current and new sterile operations.
Responsibilities include leading cross-site teams to support the above activities, providing recommendations to management.
BSc / MSc / PhD. in either Chemistry, Biochemistry, Chemical Engineering, Biochemical Engineering, Pharmacy with 5-10 years experience in pharmaceutical / Biotechnology industry.
Preferred Qualifications is MSc. in Science or Engineering, will have 5+ years of experience in support of Clinical Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
Industry experience in developing sterile manufacturing processes for GMP drug products and carry out method transfer to CMOs.
Experience in peptide / protein based drug process development is highly preferred.
Proven experience in process development for liposomes based products is an asset.
Proven experience in the tech transfer, batch document review of CMC filing of at least 2-3 investigational products at FDA, Health Canada and / or EU.
Experience including statistical analysis and design of experiments, process characterization, scale-up, and / or technology transfer experience.
Hands on experience in operating / Trouble shooting and maintenance of C5 / C55 extruder, DLS particle size analyzer, Silverson homogenizer, bench top-
Freeze-dryer and other critical GMP process related equipment.
Experience in sterile filtration of protein / peptides, liposomes and aseptic filling are highly required.
Experience with scale-up operations and support pre-IND formulations.
Excellent communication skills.