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Specialist Ii, Manufacturing Science
3 weeks ago
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
MAJOR RESPONSIBILITIES:
- Provide technical support to the Senior Specialist for technology transfer of client or internal projects from development to manufacturing- Perform technical assessments for materials, processes, equipment, and facilities- Write and execute technical study protocols as required in support of scale-up activities and troubleshooting- Work with engineering dept., and SMEs to assess and select equipment based on process need- Generate protocols, reports, batch records, standard operating procedures (SOPs), work instructions, and parts-wash / autoclave load lists to support implementation of new processes- Assist preparing technology transfer plan and readiness checklist to ensure effective and efficient transfer of new process to GMP manufacturing- Participate in engineering trials and initial GMP runs; therefore, may be required to work day, evening, and night shifts as necessary based on project schedule- Provide ongoing technical support to manufacturing group as the SME, based on assigned work and areas of expertise- Work with original equipment manufacturer and internal departments for process troubleshooting as required- 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- Investigate non-conformances or deviations from specifications, perform root cause analysis and implement corrective actions as required- Identify and implement process improvements / optimizations to achieve higher rates, yields and uptime- Support process development laboratory work when/if require- Ensure departmental compliance by staying up-to-date with assigned training curriculum- Ensure compliance to Environmental Health & Safety standards and regulations- Train existing and new staff on process specific requirements- Performs all other job-related duties as assigned
MINIMUM QUALIFICATIONS:
TECHNICAL KNOWLEDGE / EXPERIENCE:
- Understanding of standard bioprocessing techniques such as, but not limited to, various filtration technologies. chromatographic separation technologies, viral inactivation, etc.- Hands on bioprocessing manufacturing- Experience in a pharmaceutical manufacturing environment along with cGMP criteria- Excellent technical assessments abilities and with strong ability to decipher data and reach the intended end point PREFERRED QUALIFICATIONS / EXPERIENCE:
- Education in the field of science, engineering, or technical studies- Understanding of sterile filling operations and equipment- Hands on technical knowledge of small and large scale equipment (_Filtration, TFF, Chromatography, Fill Finish)_- 2 years of biopharmaceutical processing experience associated to development, tech transfer, engineering, and/or manufacturing
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 full-face respirator fit test, 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 schedule shift changes on short notice
BEHAVIOURAL:
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, analysing, 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.
- This job profile provides an overview of the minimum requirements of the job and does not include all the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization._
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 th
