Senior Scientist, Upstream Drug Development
Therapure Biopharma Inc. is a biopharmaceutical company focused on complex biological therapeutics and technologies. It is comprised of three divisions: Therapure Biomanufacturing which provides contract development and manufacturing (CDMO) services to global clients; Therapure Innovations, focused on research and development of proprietary therapeutics and platform technologies in the areas of anaemia, liver disease and organ preservation; and Therapure Biologics dedicated to the development of plasma protein therapeutics through an innovative proprietary manufacturing technology.
We are growing! In fact, from 2014 to 2017, we were recognized by Profit 500 as one of Canada’s Fastest Growing Companies.
Oversee all aspects and execute the design, development, scale-up and implementation of upstream mammalian cell culture protein production processes. Plan and carry out integrated experimental projects to complete process development objectives. Prepare documents and reports to support pre-clinical, clinical and GMP manufacturing. Monitor, recommend and incorporate state-of-the-art and industry-leading technologies and practices. All activities are conducted at a high level of independence and accountability, with appropriate interaction with other departments.
Here is what we are looking for:
- Ph.D. or M.Sc. with >5 years’ industry experience in mammalian cell culture protein expression and analysis
- Techniques for reagent, solution and equipment preparation and handling to ensure low endotoxin and bioburden (aseptic technique) at laboratory, development and production scales
- Good written and verbal communication skills
- Work well independently and in a team environment
- Able to keep meticulous laboratory and process records
- Mammalian cell culture protein expression development, DOE (Design of Experiments), cell culture harvest methods (filtration and centrifugation)
- Shake flask culture methods; bioreactors: Hyclone, Finesse, Pall; single use technologies
- Preparation of draft and final SOPs, BPRs and other documents for control and recording of GMP processes
- .Sc. or equivalent experience
- Minimum of 5 years of aseptic manufacturing experience in the pharmaceutical industry
- Minimum of 3 years in a supervisory/leadership role, preferably in aseptic processing operations
- Strong knowledge of GMPs/cGMPs as demonstrated by the ability to create/revise procedures/systems for their area of responsibility
Here is what you will be responsible for (but not limited to):
- Lead the transfer-in, development, scale-up and transfer-out of upstream mammalian cell culture protein production processes in coordination with other functional groups including cellular & molecular biology (CMB), downstream processing (DSP), and other departments such as Production, Quality Control (QC), Quality Assurance (QA), Validation, and Technical Services, as required.
- Develop, scale and execute mammalian cell culture protein production processes, from 100 L scale under appropriate conditions (development to manufacturing scale, aseptic, non-GMP, GMP grades).
- Supervise the conduct of upstream processing (USP) projects on day-to-day project and non-project activities.
- Manage non-project related activities, including providing updates to management.
- Provide scientific and technical oversight on assigned projects.
- Plan and conduct protein research and development experiments using established and newly created protocols.
- Recommend and implement processes and procedures, and communicate appropriately with Clients and internal project teams.
- Prepare project proposals, SOWs, work plans, protocols, records and reports, including general templates for use across multiple projects, and maintain project-related records and trackers.
- Complete written reports of results, analyses, scientific interpretations and summaries of experimental work.
- Present results, recommendations and future plans.
- Draft and finalizelaboratorymethods and procedures, SOPs and BPRs, and execute documents at the appropriatelevel of compliance for non-GMP and GMP projects.
- Analyze and characterize process intermediates and protein products using a range of bioanalytical techniques.
- Evaluate new equipment and techniques, and provide recommendation for change and/or purchase.
- Work on multiple projects both independently and as part of a team.
- Regularly review and provide analyses on related competitive technology and products and potential impact on project.
- Prepare documentation in support of CMC sections for INDs.
Interested candidates can send their resume and cover letter to firstname.lastname@example.org. Please reference Senior Scientist, USP in the subject line. While we appreciate all interest in this opportunity, only qualified candidates will be contacted.
NOTE:All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Therapure is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process, applicants are asked to make their needs/requirements known. Please notify Human Resources at HR@therapurebio.com for assistance.