Specialist I, Technical Services

3 weeks ago

Mississauga, Ontario, Canada Resilience Full time

A career at Resilience is more than just a job - it's an opportunity to change the future.

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

This job is responsible to support and participate in technology transfer activities, execution of engineering or GMP runs for client projects as assigned by the Senior Specialist and / or Supervisor. Activities include supporting in technology transfer related activities with MSAT colleagues and interdepartmental counterparts for efficient flow of information. This job requires individuals to obtain feedback and develop solutions for problem solving and seek opportunities to optimize processes in order to meet internal and external stakeholder expectations. This role will also support commercial operations when needed to alleviate blocking activities to production and bridge the gap between commercial operations and more senior specialists. The role will seek advice and directions from more senior specialists to successfully support the department and business.

RESPONSIBILITIES


• Provide support to internal department specialists, senior specialists and supervisors from development to manufacturing.


• Gather sufficient data/information/support evidence to support/perform the generation of technical assessments for materials, processes, equipment, and facilities.


• Draft, revise and execute technical study protocols as required in support of scale-up activities and troubleshooting.


• In correlation with departmental specialists and other department SMEs, draft protocols, reports, batch records, standard operating procedures (SOPs), work instructions, and parts-wash / autoclave load lists to support implementation of new processes.


• Provide research input, review and assessment on equipment train, with guidance from more senior specialists, for the intended process.


• Work with original equipment manufacturer and internal departments for process troubleshooting as required.


• Provide deliverables in preparing technology transfer plan and readiness checklist to ensure effective and efficient transfer of new process to GMP manufacturing.


• Participate in risk assessment activities including process risk assessment, cross-contamination risk assessment, hazard, and operability analysis (HAZOP).


• Support initiation of change controls, and complete actions according to internal procedures as required.


• Provide support in development/trial runs. Shift work may be required based on project schedule.


• Support in deviation investigation by providing evidence and technical analysis on events.


• Work with other specialists to seek out opportunities for process improvements.


• Ensure departmental compliance by staying up-to-date with assigned training curriculum.


• Ensure compliance to Environmental Health & Safety standards and regulations.


• Performs all other job-related duties as assigned.

MINIMUM QUALIFICATIONS

1. Technical aptitude for understanding and learning of bioprocessing techniques.
2. Basic understanding of cGMP and manufacturing environment.

3. Proficient with Microsoft Office applications (i.e. Word, Excel, PowerPoint).

4. Understanding of data analysis along with technical/scientific interpretation of results to identify points of significance.


PREFERRED QUALIFICATIONS

1. Educational degree in the field of science, engineering, or technical studies.
2. Understanding and experience in tangential-flow filtration (TFF), chromatography, nanofiltration
3. Understanding and experience in cell culture, seed train, bioreactors


ADDITIONAL REQUIREMENTS



• Pre-employment medical and medical re-examination performed every 2 years or as per RESILIENCE's SOPs. Included as part of the medical is a respirator fit test (half mask), and pulmonary function test.


• This position requires vaccination for Hepatitis A and B.


• Job may require shift work, weekends and occasional extended shifts and possible short notice schedule shift changes.

BEHAVIORAL

Demonstrated ability to apply the following behavioral competencies on the job:

Teamwork: Working effectively and productively with others.

Interpersonal Skills: Effectively communicating, building rapport, and relating well to all personality types.

Goal Orientation: Energetically focusing efforts on meeting a goal, mission, or objective.

Organization and Planning: Utilizing logical, systematic, and orderly procedures to meet objectives.

Problem Solving: Anticipating, analyzing, diagnosing, and resolving problems.

Decision Making: Utilizing effective processes to make timely decisions.

Written Communication: Writing clearly, succinctly and in a manner understood by the target audience.

Flexibility: Agility in adapting to change. Ability to work independently.

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 $50,000.00 - $68,750.00 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.

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