Senior Specialist, Manufacturing Science

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.

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RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We're building a robust, dynamic, and diverse network of manufacturing capability and talent -investing in innovation every step of the way.

We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines, as well as proteins and the next generation of medicines.
RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.

We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that's faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.

JOB SUMMARY:
The responsibility of this role is to take the lead in the execution of technology transfer activities, engineering or GMP runs for client projects as assigned by the supervisor or manager. In doing so, oversee activities of and/or assign the activities to junior specialists and production staff to support project activities and meet timelines. The role is expected to make the appropriate technical judgements/assessments/decisions, with input of supervisors and/or senior personnel as needed. More importantly, the role is expected to provide technical leadership with a solution minded approach to resolve potential roadblocks.
Occasional activities include process set-up, evaluation of critical and key process parameters, GMP document creation and operator training. This role also provides leadership and technical support for troubleshooting as well as training on process operations to manufacturing staff.
Lead presentations and discussions with internal project management group, senior management and clients as necessary; representing MSAT and Resilience with the utmost professionalism and integrity.

MAJOR RESPONSIBILITIES:

Process Design for Scale-up:
- Lead in transferring process from conception to at-scale manufacturing
- Monitor, track, evaluate and report data from unit operations to support project management/client communication and deliverables
- Perform statistical analysis
- Respond to and trouble-shoot process issues related to assigned work and areas of expertise
- Assess and select equipment to meet process needs
- Perform material assessments as required
- Generate protocols and reports for engineering runs, identify errors and implement appropriate CAPAs
- Develop scientific and technical understanding of unit operations and production processes

Project Leadership:
- Provide technical leadership and ownership of key project deliverables for technology transfer activities for new client projects as assigned by the supervisor
- Communicate progress to project managers against tasks and timelines for assigned projects
- Communicate any delays in timelines to the supervisor and work with the supervisor to improve timelines for deliverables
- Coordinate with other departments for planning and execution of assigned project deliverables
- Work collaboratively with other departments and company subject matter experts to achieve assigned deliverables
- Support risk assessment activities including hazard and operability studies
- Train production staff to ensure they can perform duties involving new equipment and new processes

Lead Processes for Technology Transfer to GMP Production:
- Lead GMP runs to support technology transfer to production
- Be the single point of contact (SPOC) for assigned projects amongst partnered stakeholders

- Work with original equipment manufacturer and other departments for process troubleshooting as required
- Develop specifications, standard operating procedures, work instructions and forms to support implementation of new processes
- Define and justify critical and key process parameters
- Prepare and present change controls and perform change control assessments according to internal procedures as required
- Responsible for master batch production records
- Ensure timely and accurate reporting and investigation of non-conformances or deviations associated with assigned activities
- Optimize processes to effectively and efficiently produce product that meets clients' quality specifications
- Support production/manufacturing activities in shift operations, and therefore may be required to work day, evening and night shifts as required
- Follow cGMP criteria
- Comply with safety requirements and work to resolve any environmental, health and safety issues

-Perform other related duties as assigned. Act as back-up to the supervisor when needed.

MINIMUM QUALIFICATIONS:
- Background in and hands-on understanding on process development/manufacturing
- Working familiarity with single use process systems and sterile/aseptic processing in a cGMP environment
- Experience in either upstream, downstream and/or sterile filling manufacturing systems working directly with a range of purification technologies including various filtration technologies (i.e. TFF, depth, hollow fibre), chromatographic separations technologies, viral inactivation following aseptic techniques, and sterile procedures in a cGMP environment

PREFERRED QUALIFICATIONS / EXPERIENCE:

- Bachelor of Science degree (biochemistry / chemical engineering preferred)
- 5 years of biopharmaceutical processing experience associated to development, tech transfer, engineering and/or manufacturing
- Knowledge and understanding of cGMPs, aseptic processing standards and biopharmaceutical industry guidelines
- Able to understand instructions in written, oral, diagram or schedule form
- Well organized and able to present information in a professional and precise manner
- Excellent verbal and written communication skills
- Excellent computer skills and proficiency in MS Office (Word, Excel, Outlook, PowerPoint)
- Able to work effectively under extreme pressure to meet deadlines

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 occasional use of a half face respirator
- This position requires vaccination for Hepatitis A and B
- Job requires 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:

Independence: Work with minimal supervision
Flexibility: Agile in adapting to change
Problem Solving: Anticipate, analyze, diagnose and resolve problems

Goal Orientation: Energetic focus to meet timelines and objectives
Interpersonal Skills: Effective communication. Strong leadership qualities. Able to build rapport and relate well to all personality types

This job profile provides an overview of the minimum requirements of the job and does not include all of 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 $75,000.00 - $105,000.00 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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