Regulatory Control Senior Associate
1 month ago
Apply locations CAN - ON - Mississauga - Meadowpine Blvd
Time type: Full time
Posted on: Posted 17 Days Ago
Job requisition id: p>
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
The Senior Associate I (USP Manufacturing) is a technical expert within MSAT who will support upstream process manufacturing aspects of technology transfer projects for biopharmaceutical products at RBI. The role requires the application of advanced expertise and techniques to design and establish scientifically sound, industry best practice, clinical-scale upstream manufacturing processes. The role will involve creation of cGMP documents, providing technical training to colleagues, assessing technical variables and advising on process improvements, and supporting continuous improvement initiatives in support of established manufacturing operations. On behalf of the manager, the role may also act as the authoritative approver for GMP control documents and support performance evaluations.
- Act as subject matter expert and operational lead in the design of USP manufacturing processes through different stages of projects, including but not limited to process design, preparation of GMP documents, and execution of Engineering & cGMP runs.
- Apply strong technical expertise in different USP manufacturing areas of therapeutic proteins, including cell lines (mammalian and/or insect), cell cultures in shake flasks and single-use bioreactors, cultures scale-ups, clarification, etc.
- Lead design and implementation of USP manufacturing projects into cGMP production with a stewardship approach at all stages of lifecycle from development to commercial.
- Apply effective troubleshooting/root cause analysis techniques for USP problems as required.
- Review/approve/provide guidance on technical and quality documentation related to USP manufacturing including P&ID’s, equipment qualification, validation, and design documents.
- Act as subject matter expert on USP manufacturing equipment through different stages of project including FAT, SAT, qualification and troubleshooting.
- Evaluate, recommend and support acquisition and maintenance of USP manufacturing equipment suitable for current industry standards.
- Keep abreast of relevant technology development and contribute to the implementation of new platform technologies and instrumentation that improve the quality and throughput of upstream processes.
- Documentation review of clients’ cell banks analytical testing prior to receipt at the facility.
- Support project team staff to accomplish specific tasks/team objectives within overall schedule, including completion of documentation supporting USP manufacturing projects such as Process Descriptions, Protocols, Reports, SOPs, BPRs, Risk Assessments and CMC sections as required.
- Review process data, present results, make optimization & continuous improvement recommendations as required.
- Participate in Quality and Compliance activities as required (ex. deviation investigations, change control initiation, CAPA implementation).
- Evaluate, coach, motivate, develop and train MSAT and interdepartmental staff to ensure they have a sound understanding of USP manufacturing unit operations and equipment.
RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives.
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