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Senior Process Engineer (MSAT)

Company: Amplifybio, LLC
Location: New Albany
Posted on: April 3, 2024

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.AmplifyBio's 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 Process Engineer to join our growing Manufacturing Science and Technology (MSAT) team!!! The Senior Process Engineer will be "hands-on" with the manufacturing operations, facilities, and equipment. Once the process and equipment are implemented, this position will support the manufacturing operations within the AmplifyBio GMP facility. The Senior Process Engineer will provide technical expertise to manage cell manufacturing and support the technical transfer of processes into the multi-use facility. The Sr. Process Engineer will have hands-on experience with cGMP cell therapy manufacturing and implementation of new processes into GMP facilities and will support the completion of all goals and objectives of manufacturing. It is expected that the Senior Process Engineer will work closely with other internal functional departments, as well as external clientele to ensure deliverables are met. This is a unique opportunity to be part of an emerging company bringing innovative technology to advanced therapies.What You'll Do Here:

  • Responsible for managing the transfer of CGT manufacturing processes from our clients into the AmplifyBio GMP facility.
  • Provide leadership and training of the manufacturing staff on cell manufacturing processes and equipment. Support the manufacturing staff during technical transfer, start up and in routine processing.
  • Works effectively with the other operational groups to ensure that all GMP requirements are met for the implementation of processes into the AmplifyBio facility.
  • Works closely with the Supply Chain, Quality Control, Validation, Engineering, and Quality Assurance functions internally to ensure the facility meets all appropriate standards and cell therapy manufacturing processes are performed per client and GMP requirements.
  • Coordinates Manufacturing timelines and deliverables through Joint Project Teams, Program Management, and other functions as appropriate.
  • Provides support during facility start-up and activities associated with future expansions.
  • Provide support on equipment implementation and qualification.
  • Author and reviews relevant documentation for cell manufacturing operations and equipment.
  • Position may require some travel.We Would Love to Hear from You If:
    • MS or PhD in biological sciences or engineering or BS degree in scientific field plus at least 8 years of experience.
    • Minimum of 4 + years of experience in Manufacturing or Development roles with more than 2 years in a drug product development and manufacturing function at a biotechnology or pharmaceutical company with direct involvement in the process to achieve early development milestones and successful product licensure.
    • Knowledge and experience in leading a team in transferring a process into a new facility (such as from Process Development, CMO, or Manufacturing).
    • Experience with aseptic processing and cell therapy manufacturing.
    • Experience in leading meetings, teams, and projects.
    • Demonstrated management experience including employee development and leadership.
    • Experience with issues related to manufacturing is required.
    • Knowledge of current requirements for cGMPs required and knowledge of GLP/GTP/GCP is a plus.
    • Experience with regulatory submissions or supporting regulatory filings.
    • Forward-thinking and creative with high ethical standards.
    • Team player with leadership skills with ability to influence others to achieve successful manufacturing campaigns and to enable regulatory product approvals.
    • Well organized and self-directed.
    • Strong interpersonal skills with an ability to communicate to people at all levels of an organization.Desired But Not Required:
      • PhD in related field of study.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 affiliation, or any other factor protected by federal, state, or local law. AmplifyBio will not tolerate discrimination or harassment based on any of these characteristics. If you have a disability or special need that requires accommodation, please let us know during the recruiting process. We are committed to the safety and wellness of our employees and customers. Therefore, COVID vaccination is required.Why You Will Love Working Here:We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.
        • Health, Dental, and Vision insurance that starts on your first day at AmplifyBio!
        • Competitive Compensation Package
        • We take work-life balance seriously and we back it up with an UNLIMITED PTO policy!
        • Life and AD&D insurance
        • Supplemental insurance
        • LiveHealth Online
        • Smart Shopper (helps you shop for better medical care and earn cash rewards while you save)
        • Generous paid parental leave
        • Wellness and Self-Care Programs
        • 401(k) match
        • Tuition Reimbursement
        • EAP/work-life support system
        • A fun work environment where everyone's voice matters.
        • We are just getting started! More benefits on the way!
        • An Opportunity to Change the World!!!

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Keywords: Amplifybio, LLC, Columbus , Senior Process Engineer (MSAT), Other , New Albany, Ohio

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