Sr. Director of MSAT & Operations

Company: Amplifybio, LLC
Location: London
Posted on: May 28, 2023

Job Description:

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!AmplifyBio is a company dedicated to building an integrated environment where clients can access technologies, platforms, capabilities, and safety testing for the scale up and commercialization of advanced therapies. We began as a CRO, spun out from the Battelle organization in West Jefferson, Ohio and are now proud to have added a site in South San Francisco dedicated to discovery, optimization, and characterization of client drug candidates and soon to launch facility in New Albany, OH.The platforms and domain expertise at our New Albany site will fill the critical gap that exists between discovery and the clinical scale up of drug development. The team here is dedicated to helping clients understand the biological and immunological mechanisms and characteristics of their advanced therapies to ensure product consistency and prevent unexpected failures downstream.We partner with our clients, leveraging state-of-the-art technologies and platforms we will enable our customers to accelerate and improve the product development cycle, from concept to commercial. When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians and specialists across a variety of disciplines. Our chemists, biologists, veterinarians, data scientists, engineers, pathologists, and other experts collaborate to deliver new and exciting breakthroughs. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees. AmplifyBios next step forward in advancing medical breakthroughs, treatments, and cures for disease is to establish a Cell & Gene Therapy (CGT) manufacturing and development facility. We are seeking highly motivated individuals to help create and define a first-of-its-kind CGT facility at our new site in New Albany, OH. AmplifyBio is seeking to hire a Senior Director, Manufacturing Science and Technology (MSAT) and Operations to join our growing team!!! The Senior Director, Manufacturing Science and Technology (MSAT) and Operations will report to the SVP, Technical Operations and focus on liaising with our clients to transfer and support the establishing of their respective manufacturing processes. This will be a unique opportunity to learn new cutting-edge science and processes and help our clients get their product into the clinic and impact patient lives. The role will also be back for the SVP Technical Operations. We are seeking a highly experienced MSAT and Operations leader who will provide strategic leadership for novel technology qualification, product comparability, process technology transfer and GMP manufacturing for Amplify Bio. This role will work with cross-functional leaders to advance and achieve important MSAT milestones.What Youll Do Here:

• Manage a team to lead, develop and implement scientifically sound and fit for purpose global validation policies and procedures based on current regulations, industry standards and industry practices for cell therapy.
• Support the client with ongoing process operations on site to ensure our clients can meet their objectives while ensure the processes and hoteling suites remain in a state of control.
• Provide leadership and direction for Site MSAT and manufacturing Technical SMEs to define the validation requirements for execution of clients manufacturing processes.
• Engage with senior levels leaders within AmplifyBio and in our clients to deliver the strategic imperatives for both organizations.
• Develop and maintain qualification responsibilities include technical support for equipment qualification standards, framework for harmonized risk-based qualification strategies for similar equipment and unit operations across plants.
• Continuously seek to optimize the manufacturing processes to ensure effective use of capacity and minimize costs.
• Interface cross-functionally with Process Development, Quality, Manufacturing and Engineering to implement new processes and technology as part of technology transfers as needed.
• Partner with clients to define requirements and understand functional specifications.
• Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and solving equipment process issues.
• Explore, assess and recommend new equipment which improves manufacturing processes from a cost, efficiency, quality and compliance perspective.
• Perform stage gate reviews on new incoming processes/changes to ensure the change is ready for introduction to Manufacturing as an improvement to the performance in the manufacturability for the process. This includes acceptable process characterization, risk assessments and mitigation and robust supporting data for the proposed changes.We Would Love to Hear from You If:
  • Bachelors degree with 10+ years of equipment and process validation, technology transfer or pharmaceutical manufacturing experience.
  • Experience in building organizations to meet the operations requirements.
  • 6+ years of directly related industry experience in GMP manufacturing with direct experience managing a team as well as leadership experience leading teams, projects, programs or directing the allocation of resources.
  • Ability to engage senior leaders within the organization and our clients.
  • Biologics or aseptic processing experience.
  • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) with process validation experience.
  • Thorough understanding of cGMP manufacturing.
  • Excellent communications and written skills with direct experience supporting significant strategy development & implementation.
  • Knowledge of data management tools and statistical process.
  • Adapting and thriving in a rapidly changing and fast-moving environment. At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization. Research shows that oftentimes women and minority groups only apply to open roles if they meet 100% of the listed criteria. AmplifyBio encourages everyone including women, people of color, individuals with disabilities and those in the LGBTQIA+ community to apply for our available positions, even if they don't necessarily check every box on the job description. Hire for attitude and train for aptitude creates unique opportunities to build strong teams of smart, motivated individuals who love what they do. AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political aPI216453160

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