Senior Process Engineer (GMP)

Senior Process Engineer (GMP)

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.

The platforms and domain expertise at our San Francisco site fills 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 South San Francisco, CA.

AmplifyBio is seeking to hire a Senior Process Engineer to join our Manufacturing Science and Technology (MSAT) team!!!

This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.

This position is responsible for supporting the activities involved in the transfer of clients many different processes into our manufacturing facility as well drive continuous improvement initiatives on the manufacturing process thereafter to support the clinical immunotherapy products. The candidte will have/gain hands-on experience with cGMP cell therapy or other manufacturing platforms.

It is expected that the Sr. Process Engineer will work closely with other corporate functional areas as well as outside vendors to ensure deliverables are met.

What You’ll Do Here:

  • Support the transfer of cell therapy and other manufacturing processes from our clients to the Amplified Bio GMP facility.
  • Provide expertise and training to the manufacturing staff on the T cell and/or other manufacturing processes and equipment.
  • Support the manufacturing staff during technical trans start-up up and in routine processing.
  • Work effectively with the other operational groups to ensure that all GMP requirements are met for the implementation of the ABiofacility.
  • Work closely with the Supply chain, Quality Control, Validation, Engineering, Quality Assurance, and Regulatory Affairs functions internally and clients externally to ensure the facility meets all appropriate standards and T cell/other manufacturing processes are performed per GMP requirements.
  • Coordinate Manufacturing timelines and deliverables through the CMC team, Program Management, and other functions, as appropriate.
  • Provide support to the equipment implementation and qualification
  • Provide, write, and review relevant documentation for T cell/plasmid manufacturing operations and equipment.
  • Position may require some travel.

We Would Love to Hear From You If:

  • Bachelors  degree in a related scientific field with 8+ years of experience of related experience or a Masters degree with 5+ years of experience.
  • 5+ years of experience in Manufacturing or Development roles with more than 3+ years in a drug product development and manufacturing function at a biotechnology or pharmaceutical company.
  • Experience with aseptic processing and cell therapy manufacturing.
  • Experience in leading meetings, teams, CMOs.
  • Demonstrated management,t experience, including employee development and leadership.
  • Experience with issues related to manufacturing is required.
  • Knowledge of current requirements for GLP, cGMP, and GCP is also required.
  • Direct experience with regulatory submissions.
  • Forward-thinking and creative with high ethical standards.
  • Team player with ability to influence others to achieve successful regulatory Well-organizedetings.
  • Well organized and self-directed.
  • Strong interpersonal skills with an ability to communicate with people at all levels of an organization.

At AmplifyBio, we’re committed to growing and empowering an inclusive community within our company and industry. This is why 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 generous PTO
  • 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!!!

Apply Today!

Scaling science for life.