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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.

For more information, please visit www.resilience.com

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.

RESPONSIBILITIES:

Technical Responsibilities

· 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

· As required, 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

· Support culture of process improvement with a focus on streamlining processes, adding value to our business and meeting client needs

Functional Responsibilities

· Participate in technology transfer activities of client and internal 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

· Lead and/or participate in execution of USP manufacturing in cGMP clean rooms, including operation of manufacturing equipment (e.g. seed trains, bioreactors, metabolite analysis)

· 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

· Interface with clients and other internal departments, present plans and results as appropriate (e.g. PAD, Engineering, Manufacturing, Validation, Quality Assurance)

· As required, support design and execution of lab-scale experiments, analyze data and report results

· In areas of health, safety and environmental policies, contribute toward meeting Departmental / Company goals

· Evaluate process trends and KPIs to proactively troubleshoot and correct processes before deviations occur

· Perform any other job-related duties as assigned

Minimum Qualifications

· 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

· Operational knowledge and hands-on experience with various USP manufacturing equipment including incubators, bioreactors inclusive of single-use bioreactors and shake flasks

· Excellent technical problem solver, critical thinker

· Works well independently and in a team environment

· Excellent written and verbal communication skills

Preferred Qualifications

· Doctorate or Master’s degree in Bioprocess/Biochemical Engineering, Microbiology, Cell Biology

· Minimum of 7 years of recent scientific and industrial experience in a biotechnology manufacturing environment

· Operational knowledge of cell line development - preferably with mammalian and insect cell culture

· Knowledge of aseptic techniques and cGMP experience

· Data analysis and report preparation with knowledge of MS Word, Excel, PowerPoint and Outlook

· Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines

· Operational knowledge of molecular biology and analytical assays

ADDITIONAL REQUIREMENTS:

· Pre-employment medical and medical re-examination performed every 2 years or as per Resilience’s SOPs.

· This position requires vaccination for Hepatitis A and B

· Job requires occasional shift work, weekends and extended shifts, with possible schedule shift changes on short notice

The items described here are representative of those that must be met successfully to perform the essential functions of this job

Resilience Biotechnologies Inc. (RESILIENCE), 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 to Human Resources.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, 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. Our target base pay hiring range for this position is $75,000.00 - $108,750.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.