Manager, Upstream Process Manufacturing Operations

COMPANY SUMMARY:

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 current role requires the application of advanced expertise and techniques to design, develop, and establish scientifically sound upstream bioprocess methods for the manufacturing of biopharmaceutical products. The Manager Upstream Manufacturing is responsible for leadership of the upstream operations’ team of RBI and oversights the design, construction, commissioning, validation and execution of drug substance in RBI’s manufacturing facilities with focus on the upstream operations. The position supports technology transfer, process design, set-up and operation, non-GMP and CGMP document creation and technical training. It also provides technical support, training, and troubleshooting to USP Manufacturing team including but not limited to mammalian and/or insect cell cultures, seed trains, bioreactor operation, metabolite analysis, process optimization, as well as documentation and reporting of the results.

MAJOR RESPONSIBILITIES:

1. Team Leadership

• Lead Upstream Process (USP) Manufacturing Operations team with a strong technical expertise; strengthen Phase I-III manufacturing process and product knowledge
• Manage multiple issues/challenges and make decisions in a high paced environment with changing priorities
• Lead the organization’s growth to support projects execution and batch manufacturing
• Ensure that all ongoing USP Manufacturing Operations activities meet the expected target dates and deliverables
• Provide scientific, technical support and rational to increase efficiency in operations
• Ensure all ongoing supporting activities (such as Deviation management, Change Control management, CAPA management) meet the expected target dates and deliverables
• Establish and maintain close connection with production and Quality teams
• Ensure capability for effective root cause investigation and deviation assessment and support inspection activities
• Lead USP Manufacturing Operations team members Improvement Plans to ensure a high performing team; utilize continuous improvement tools and guidance to USP Manufacturing Operations team members
• Lead the growth of USP Manufacturing Operations team by overseeing talents acquisition
• Train and supervise technical staff in methods and procedures
• Accountable for a safe workplace by supervising and monitoring compliance with employment and health and safety legislation
• Ensure that employees work within the policies, procedures and regulations including responding promptly to all health and safety concerns or incidents
• Schedule resources, task-tracking and client/vendor interaction
• Perform all other related tasks as assigned

2. Technical leadership

• A strong technical expertise in the full scope USP of therapeutic proteins’ manufacturing including cell lines (mammalian and/or insect), cell cultures in shake flasks and bioreactors (preferably single use bioreactors), cultures scale ups, clarification, etc. for Phase I-III manufacturing
• Maintain expertise of the USP team to conduct troubleshooting and projects deliverables
• Subject Matter Expert and operational lead supporting the design of relevant USP Manufacturing Operations through different stages of project, including but not limited to URS preparation, DQ, IQ/OQ/PQ execution, Engineering Runs
• Ensure accurate and timely completion all required documentation supporting the conduct of USP Manufacturing Operations projects, including but not limited to Process Designs, Outlines, Reports, SOPs, BPRs, CMC sections
• Manage out-sourced services related to processes and supporting testing as required
• Present results, recommendations and future plans as required
• Regularly review and provide analysis on related competitive technologies, methods and equipment and potential impact on projects
• Recommend, acquire and maintain equipment suitable for current industry standard USP Manufacturing Operations
• Maintaining compliance with current Good Laboratory Practices (CGLP) and current Good Manufacturing Practices (CGMP) Regulatory standards, as well as identify, review and recommend continuous quality improvements
• Lead and/or participate on project teams and interface with other departments, e.g., Manufacturing Sciences and Technologies
• Oversight of process operations contributing to design and troubleshooting of process and equipment issues through different stages of the project including FAT, SAT, and engineering stages
• Review and approve and provide guidance with respect to technical and quality related documentation for Upstream Process Manufacturing Operations including P&ID’s, qualification, validation, and design documents
• Support knowledge transfer of the USP process in close collaboration with Department of Drug Development and MSAT
• Oversee execution of all engineering, definition, development, validation and consistency batches
• Oversee execution of the upstream facility environmental monitoring PQ
• Performs all other related tasks as assigned

3. Functional Responsibilities

• Ensure product related technical issue resolution and/or product/process improvements
• Report on a regular basis the overall Product/Process related activities to the USP team head
• Responsible for supervising and training staff to achieve continuous performance improvement. This requires hands-on presence in the lab and clean rooms when required
• In areas of health, safety and environmental policies, contribute toward meeting Departmental/Company goals
• Apply effective troubleshooting/root cause analysis techniques for USP problems as required
• Participate in technology and technical transfer activities of client and internal processes
• Accountable to meet schedule completion dates or to provide timely feedback when dates cannot be met. Support project staff to accomplish specific task/team objectives within overall schedule
• Interact with project team members and peers to anticipate and resolve day to day issues. Interact with other divisions, customers and suppliers on routine matters to achieve results
• Execute experiments, analyze data and report results
• Identify, offer, and implement contingency plans to prevent and overcome issues and perform method trouble shooting
• Identify issues, solve problems and incorporate changes into ongoing development and production
• Operate, optimize and troubleshoot USP processes with minimum supervision
• Keep abreast of relevant technology development and contribute to the implementation of new platform technologies and instrumentation that improve the quality and throughput of upstream processes
• Routine maintenance of Master Cell Banks and Working Cell Banks. This includes the documentation review of Clients’ cell banks analytical testing prior to receipt at the facility
• Perform any other job-related duties as assigned

MINIMUM QUALIFICATIONS:

• Doctorate or Master’s degree in a Bioprocess/Biochemical Engineering, Microbiology, Cell Biology
• Minimum of 5 years of recent scientific and industrial experience in a high technology environment
• Operational knowledge of cell line development, molecular biology, bioreactor operation and theory
• A deep knowledge of upstream processing, including recombinant protein expression, cell culture techniques, at small, intermediate and large scale, as well as development of scale down models
• Excellent communicator at all levels of the organization, technical problem solver, efficient conflict mediator, a thorough team motivator, critical thinker and encourages critical thinking within the Team
• Team builder with strong soft skills, including team creation and development, strategy setting and execution, vision creation and alignment
• Work well independently and in a team environment
• Excellent written and verbal communication skills

TECHNICAL KNOWLEDGE / EXPERIENCE:

• Upstream Processing and experience with mammalian and insect cell cultures
• Hands-on experience in working with mammalian, insect and bacterial cell cultures in shake flasks and bioreactors (preferably single use bioreactors)
• Knowledge of Aseptic techniques and CGMP experience
• Operational knowledge of various bioreactors, including Single-Use systems
• Knowledge of scale-up strategies and equipment requirements
• Data analysis (CGMP and Development) and report preparation with knowledge of MS Word, Excel, PowerPoint and Outlook
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• A detailed knowledge of the scientific method and its application to establish procedures in a logical progression

PREFERRED QUALIFICATIONS:

• Experience with Quality by Design (QbD) in concept, design and application
• Experience with design of experiments (DoE)

ADDITIONAL REQUIREMENTS:

• Pre-employment medical and medical re-examination performed every 2 years will be required as per Resilience’s SOPs.
• This position requires vaccination for Hepatitis A and B

BEHAVIOURAL:

Demonstrated ability to apply the following behavioral competencies on the job:

Goal Orientation:Energetically focusing efforts on meeting a goal, mission or objective

Flexibility:Agility in adapting to change

Decision Making:Utilizing effective processes to make decisions

Creativity/Innovation:Adapting traditional or devising new approaches, concepts, methods, models

Problem Solving:Anticipating, analysing, diagnosing and resolving problems

Organization and Planning:Utilizing logical, systematic and orderly procedures to meet objectives

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.