Job Description

RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We\xe2\x80\x99re building a robust, dynamic, and diverse network of manufacturing capability and talent \xe2\x80\x93 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\xe2\x80\x99s 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 Senior QC Manager will plan, budget for, and maintain adequate resources (trained personnel, equipment, and materials) necessary to efficiently execute Quality Control operations. The Senior QC Manager will ensure high Quality standards for operation and documentation relating to Quality Control to meet regulatory, client and Resilience requirements and expectations.

Major Responsibilities:

Manage the assigned projects by closely working with project managers completing the related tasks in a timely manner.

Ensure that project plans are created according to QC capacity to ensure timely execution and completion of test method transfers and qualifications/validations.

Ensure accurate and timely completion and approval of Quality Control laboratory testing and records.

Ensure implementation and execution of laboratory control programs including documentation control, sample/reagent control, reserve/stability samples, LIR and out of specification investigations.

Implement programs to assure continuous improvement of procedures and processes (test methods and system SOPs).

Oversee the execution of test method development and optimization.

Ensure the execution of stability studies to meet client requirements and ICH guidelines.

Oversee the creation, approval, training and implementation of QC test methods and training modules.

Ensure staff record and report according to established procedures any deviations from company procedures, or other discrepancies that may affect or indicate a problem with product quality; determine and implement any immediate corrective action as necessary; ensure the development of long-term corrective action including identifying root causes; facilitate, review and approve final implementation of corrective action plans.

Implement robust programs to ensure that applicable equipment and analytical instruments are qualified, maintained, and calibrated, and that system suitability is properly verified. Review and approve QC equipment IQ/OQ/PQ protocols and reports.

Ensure that the laboratory facilities and operations follow Safety and Environmental regulations, including chemical handling and disposal of laboratory waste.

Report Health and Safety incidents, accidents, or potential hazards.

Ensure all departmental staff is trained to perform duties prior to performing a function

Review and approve CoAs for batch release.

Perform any other job-related duties as assigned

Minimum Qualifications:

BSc. in chemistry or a related science

Significant QC experience in Pharmaceutical / Biopharmaceutical industry

Demonstrated leadership and management skills

Working knowledge of FDA, Health Canada, and EU GMPs

Knowledge of ICH guidelines regarding transfer and validation of analytical methods, as well as stability program

Willingness to work overtime or weekends as needed to meet business needs

Preferred Qualifications:

Client management experience will be considered an asset

Experience managing small to mid-sized teams

Experience leading investigations and performance improvement projects

Be self-motivated, highly organized, and able to work in the fast-paced environment

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

Leadership: Achieving extraordinary operational results through inspiring, encouraging and developing people

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

Conflict resolution - Effectively broker solutions to resolve conflicts between individuals and groups.

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.

While we appreciate your interest in this opportunity, only qualified candidates will be contacted. Resilience Biotechnologies Inc. (RESILIENCE), will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to directly Resilience Biotechnologies Inc. (RESILIENCE), or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Resilience Biotechnologies Inc. (RESILIENCE), Human Resources team.

NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).

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 annualized base pay hiring range for this position is $119,000.00 - $150,500.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate\xe2\x80\x99s 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.

National Resilience