Senior Director, Manufacturing Operations (GMP) - Jobs in Chaldecutt

Job Description

October 5, 2023 Job ID: 21507AbCellera is breaking the barriers of conventional antibody drug discovery to bring better medicines to patients, sooner. AbCellera #39;s engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotechs and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.The Senior Director, Manufacturing Operations (GMP Manufacturing) will be responsible for building a team and designing facilities to meet an audacious goal: to go from discovery to fill-finish in a year. You will be given the freedom to innovate and move at lightning speed to create a legacy in our industry.We #39;re offering a generous compensation package including an equity stake in AbCellera #39;s success. Our future facility will be nestled in the heart of Vancouver, Canada - we #39;ll support you and your family in every way we can to relocate if you haven #39;t had the joy of living in this beautiful area!In this role you will be the senior manufacturing operations leader responsible for the design, construction, qualification, and operation of a new GMP manufacturing facility for the production of antibody therapeutics. The facility will produce API for global clinical studies and will be based around 2x2000 L single use bioreactors. You will be responsible for building an exceptional team and will be the senior manufacturing leader on-site when the facility is operational. You will be a key leader at AbCellera responsible for delivering on a critical strategic program that will have a long-lasting legacy on the organization and Canada.We #39;d love to hear from you if

• You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions
• You are passionate about building dynamic new teams and capabilities that accomplish important goals
• You have a bias towards innovation over industry standards
• You are enthusiastic about applying your expertise in manufacturing operations
• You are an outstanding communicator and teammate

How you might spend your daysAs the senior leader in the establishment of the GMP Manufacturing Department for the new GMP Manufacturing facility and operation. This includes:

• Providing exceptional leadership to the organization, including hiring, mentoring, and developing staff
• Serving as the senior Manufacturing Operations leader for the design, construction, and start-up of a new GMP Manufacturing facility for the production of antibody therapeutics. This includes:
• Working with AbCellera site leaders to ensure facility design will meet all strategic requirements related to capabilities, scale, capacity, cost, and timeline
• Ensuring facility is designed for the future, including the ability to implement innovative manufacturing approaches, add additional capacity, and/or extend into other competency areas (e.g., drug product manufacturing)
• Hiring and leading the team members for Manufacturing Operations department responsible for all aspects of facility design, construction, qualification, and start-up of the new facility
• Designing and operating manufacturing systems that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Working closely with site leadership and Quality peers to develop and implement all GMP systems with an emphasis on paperless eSystems
• Successfully bringing the facility online for GMP manufacturing operations
• Overall responsibility for leading the Manufacturing Operations department once the facility is online. This includes:
• Hiring, leading and mentoring an exceptional team to run GMP manufacturing operations including GMP production, materials management and manufacturing compliance. This includes working to establish a powerful culture integrated with AbCellera #39;s operations
• Being a champion for innovation; working closely with AbCellera peers on the development and implementation of novel technologies and systems
• Working closely with TechOps peers in Processamp; Analytical Development to establish a paradigm for efficient process transfer and for SME technical support to manufacturing
• Promoting a progressive culture of World Class GMP Manufacturing Operations
• Ensuring the schedules of the people, facility, equipment, materials, and documents are established and maintained to support the capacity/throughput of the facility.
• Ensuring the facility is designed and operated at a high-level of GMP compliance. This includes:
• Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effect therapies to patients
• Working closely with the site leadership and Quality peers to ensure the operation uses a risk-based approach to Quality
• Ensuring all aspects of the operation are aligned with regulations/guidance/expectations from global regulatory agencies, including Health Canada, FDA, and EMA.
• Providing senior leadership to ensure the facility and operation is prepared for all quality audits by AbCellera partners and regulatory inspections by global regulatory agencies and that any findings are addressed promptly
• Reviewing and approving controlled master documents including standard operating procedures, batch records, material specifications, and validation protocols.
• Ensuring deviations from approved procedures are (1) accurately recorded in the original documentation and (2) are properly justified/investigated with respect to impact to the process and/or product.
• Supporting CMC sections of regulatory filings
• Budgeting and planning, including:
• Working closely with AbCellera Business Development team to support establishment of global partnerships for antibody discovery-through-GMP
• Establishing and effectively managing operating budgets for the GMP Manufacturing site

Requires skills and experience

• 12-15+ years of experience in manufacturing of biologics in a GMP setting;
• 6+ years of experience in a leadership role managing Technical Operations, Process Development, and/or GMP Manufacturing Operations
• Outstanding technical acumen, operational understanding, and GMP compliance in building and managing the new GMP facility
• Strong leadership passion to build, lead, and mentor a team with the opportunity to leave a lasting legacy on the team, the organization, and the country
• A desire to innovate and push to do things differently
• Strong knowledge of GMP systems and GMP manufacturing operations
• Strong communication, teamwork and relationship building skills across the organization
• The ability to apply pragmatic, risk-based decision making to the operation
• Strong ability to be strategic, yet hands-on and detail oriented
• Experience leading a site through Quality audits and/or regulatory inspections
• Experience with CMC regulatory filings
• A BS/MS/PhD in Biological Sciences or Engineering. Graduate degree preferred

About AbCelleraAt AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You #39;ll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. This is life-changing research and you could be a part of it.We #39;re a growing company with state-of-the-art discovery tools and the drive to be the best in the industry. This isn #39;t just about having the best technology. We know we need a world-class team of innovators working together to solve the toughest problems. We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success. We #39;re looking for someone like you to support and organize our efforts along the way.#LI-EM1#LI-DR