Specialist II, Manufacturing Science & Technology

Resilience; Mississauga; On-site; CAD 60,000 - 87,000; Full time

Job summary

An innovative biomanufacturing company is seeking a skilled individual to support technology transfer and engineering runs. This role involves providing technical expertise, conducting assessments, and optimizing processes for client projects. You'll collaborate with various teams to ensure compliance and efficiency while also mentoring junior staff. Join a forward-thinking organization that values your contributions to the biomanufacturing revolution and offers a robust rewards program, including competitive pay and comprehensive benefits.

Benefits

Annual Cash Bonus

RRSP/DPSP with Company Match

Comprehensive Healthcare Benefits

Tuition Reimbursement

Flexible Time Off

Paid Holidays

Parental Leave Top-Up

Employee Referral Program

Qualifications

• Hands-on experience in bioprocessing manufacturing.
• Understanding of standard bioprocessing techniques.
• Experience in a pharmaceutical manufacturing environment.

Responsibilities

• Provide technical support for technology transfer activities.
• Perform technical assessments for materials and processes.
• Write and execute technical study protocols.

Skills

Bioprocessing Techniques

Technical Assessments

Data Analysis

Microsoft Office

Problem Solving

Education

Degree in Science or Engineering

Tools

Filtration Technologies

Chromatography

GMP Documentation

Job description

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 www.resilience.com

This job’s responsibilities include technology transfer activities and execution of engineering or GMP runs for client projects as assigned by the Senior Specialist or Supervisor. Activities include technology transfer assessments, material assessments, process set-up, technical writing, GMP document creation, operator training, etc. This job provides direct technical support for troubleshooting and process optimization to meet client specifications and internal quality requirements; the role also provides ongoing support to production throughout a project as the process subject matter expert (SME). Additionally, this role will provide guidance to more junior specialists and seek advice and support from senior specialists or supervisor to successfully execute assigned tasks. The role may require interactions with upper management as well as clients on behalf of senior specialists and the supervisor as part of the overall professional development. Other activities may include supporting process development work if required.

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

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

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:

Demonstrated ability to apply the following behavioural 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, 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 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 $60,000.00 - $86,250.00 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.