MMR Consulting Inc.
At MMR Consulting, we specialize in delivering innovative engineering and project management solutions to clients in the pharmaceutical, biotechnology, and life sciences industries. Our team of highly skilled professionals is committed to providing customized, cost-effective, and regulatory-compliant solutions that support operational efficiency and project success.
Our expertise includes process engineering, validation, automation, facility design, and project management. We take a strategic and client-focused approach to each engagement, ensuring that solutions are tailored to meet specific project requirements while aligning with industry standards, regulatory expectations, and best practices.
Senior Consultant (Research and Development)
The Senior Consultant (Research and Development) is responsible for planning, directing, and evaluating scientific research, process development, and validation activities related to pharmaceutical and biologics manufacturing. The role provides leadership and oversight to multidisciplinary technical teams and ensures that all activities are conducted in compliance with cGMP standards and regulatory requirements.
The position operates in a managerial and technical leadership capacity, coordinating complex projects, guiding validation and process engineering initiatives, and supporting organizational objectives related to operational efficiency, product quality, and regulatory readiness.
Responsibilities
- Plan, organize, direct, control, and evaluate scientific research and development projects related to pharmaceuticals and biologics.
- Oversee and guide the design, coordination, and execution of chemical experiments, testing programs, and analytical studies using techniques such as chromatography, spectroscopy, microscopy, and physical and chemical separation methods.
- Direct and oversee the operation, optimization, and qualification of laboratory and production systems, including fermentation systems, bioreactors, centrifugation, downstream purification processes (chromatography, TFF, NF, UF), fill-and-finish equipment, isolators, compounding systems, media preparation, CIP/SIP systems, and clean utilities (PW, WFI, CS, PS, PCA, PN).
- Establish and implement scientific policies, standards, operating procedures, and health and safety measures to ensure compliance with cGMP, regulatory requirements, and internal quality systems.
- Lead and oversee programs of sampling, analysis, and validation to maintain and improve quality standards for raw materials, intermediates, and finished products.
- Supervise, mentor, and evaluate scientific and technical personnel, providing leadership in commissioning, qualification, validation, and process development activities.
- Provide strategic and technical leadership in process engineering, cleaning validation, and the development and scale-up of experimental and pilot-scale systems.
- Review, approve, and interpret experimental data, validation protocols, and technical reports, and present findings, recommendations, and project updates to senior management and stakeholders.
- Represent the organization in technical discussions and meetings with clients, regulatory authorities, and industry partners, and support regulatory inspections and audits as required.
Qualifications:
- Master’s degree or PhD in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a closely related scientific discipline.
- Minimum of 5 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 2 years in a supervisory or managerial capacity overseeing scientific or technical teams.
Demonstrated expertise and leadership in:
- Oversight of commissioning and qualification (C&Q) programs for facilities, utilities, and equipment within GMP-regulated environments
- Management of cleaning validation programs, including CIP system design, cycle development, and validation strategy approval
- Process engineering and automation, including review and approval of URS, functional specifications, and system design related to valve matrices and automated systems
- Implementation of risk-based and lean validation methodologies to support efficient project delivery and regulatory compliance
- GMP facility design review and application of Good Engineering Practices (GEP)
- Oversight of computerized systems validation (CSV) and implementation of paperless validation platforms such as Kneat and ValGenesis
- Management of validation lifecycle activities, including protocol approval, deviation management, and final report authorization
- Supervision of aseptic processing practices, including rinse and swab sampling programs and environmental monitoring
Leadership & Core Competencies
- Proven ability to lead multidisciplinary teams, including validation engineers, process engineers, and laboratory personnel
- Strong project management capabilities, including planning, resource allocation, and execution of complex scientific and validation programs
- Ability to make technical decisions, provide strategic direction, and ensure timely completion of projects
- Excellent communication skills, with the ability to present complex scientific and technical information to senior management, clients, and regulatory authorities
- Strong problem-solving and analytical skills within highly regulated environments
Additional Requirements
- Ability to travel occasionally within Canada as required for project and operational needs
- Eligibility for travel to the United States is considered an asset
What We Offer
- Full-time, permanent employment.
- Annual salary of $139,000, commensurate with the seniority and scope of the position.
- Comprehensive benefits package, including medical, dental, and disability insurance.
- Reimbursement of reasonable work-related expenses in accordance with company policy.
- Standard work schedule of 40 hours per week, with hybrid work arrangements (combination of in-person and remote work) available based on operational requirements.
Location of Work
3100 Steeles Ave W, Suite 500C
Vaughan, ON
L4K 3R1, Canada
How to Apply
Interested candidates are invited to submit their resume and cover letter by applying directly to this job posting.
We thank all applicants for their interest; however, only those selected for further consideration will be contacted.