USP Manufacturing Process Specialist

1 week ago

Mississauga, Ontario, Canada Resilience Full time
Resilience is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines.

We are seeking an experienced USP Manufacturing Process Specialist to join our team in Mississauga, Canada.

The estimated salary for this position is $85,000 - $110,000 per year, depending on qualifications and experience.

In this role, you will be responsible for supporting upstream process manufacturing aspects of technology transfer projects for biopharmaceutical products at Resilience. This will involve the application of advanced expertise and techniques to design and establish scientifically sound, industry best practice, clinical-scale upstream manufacturing processes.

Your key responsibilities will include:
  • Acting 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.
  • Applying 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.
  • Leading design and implementation of USP manufacturing projects into cGMP production with a stewardship approach at all stages of lifecycle from development to commercial.
  • Applying effective troubleshooting/root cause analysis techniques for USP problems as required.
  • Reviewing/approving/providing guidance on technical and quality documentation related to USP manufacturing including P&ID's, equipment qualification, validation, and design documents.

You will have the opportunity to work on various aspects of USP manufacturing, including:
  • Evaluation, recommendation, and support acquisition and maintenance of USP manufacturing equipment suitable for current industry standards.
  • Keeping abreast of relevant technology development and contributing 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.

To succeed in this role, you will need to have:
  • A deep knowledge of upstream processing, including recombinant protein expression and cell culture techniques, at small, intermediate, and large scale, as well as development of scale down models.
  • Excellent technical problem-solving skills and critical thinking abilities.
  • Minimum 7 years of recent scientific and industrial experience in a biotechnology manufacturing environment.
  • Knowledge of aseptic techniques and cGMP experience.
  • Data analysis and report preparation with knowledge of MS Word, Excel, PowerPoint, and Outlook.

We offer a competitive benefits package, including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dental care, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program.

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