Do you want to be part of a growing world-class organization focused on bettering our world? 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 newly established, commercially focused preclinical CRO that was created as a Battelle spin-off. Aligned with, and supported by leading life sciences-focused investors, we partner with our clients to provide preclinical CRO services from single study and through full IND enabling studies. We have a strong focus and commitment to helping accelerate the commercialization of advanced therapies such as cell and gene therapies and vaccines.
Moving forward we will combine continuous improvement and innovation to become the preferred preclinical CRO in the industry, by working in partnership with our clients, and 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 Process Engineer or Senior Process Engineer to join our Manufacturing Science and Technology (MSAT) team!!!
We are currently recruiting for a Process Engineer who will report to the MSAT & Operations Director. This will be a unique opportunity to see your ideas rapidly translate into the clinic and impact patient lives.
The Process Engineer 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 candidate will have/gain hands-on experience with cGMP cell therapy or other manufacturing platforms.
We are seeking a highly experienced individual who can write technical and operational documentation, create procedures, programs, and policies, and lead small projects through planning and implementation execution. It is expected that the 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 AmplifyBio GMP facility.
- Provide expertise and training to the manufacturing staff on Cell & Gene therapy manufacturing processes and equipmen.t
- Support the manufacturing staff during technical transfer start-up and routine processing.
- Work effectively with other operational groups to ensure that all GMP requirements are met for New Product Introduction and process improvement implementations.
- Work closely with the Supply chain, Quality Control, Facilities & Engineering, and Quality IT, Quality Assurance functions internally and clients externally to ensure the facility meets all appropriate standards and CGT manufacturing processes are performed per GMP requirements.
- Coordinate Manufacturing timelines and deliverables through Program Management, Joint Project Teams, and other functions as appropriate.
- Provide support to the equipment implementation and qualification.
- Author and review relevant documentation for CGT manufacturing operations and equipment.
- Work with QA on quality record management and approval, including Change Control and Deviations.
- Support transition of processes from research and development, and design and execute process development studies for process optimization and robustness
- Position may require some travel.
We Would Love to Hear from You If:
- Senior Process Engineer:
- Bachelors degree in a related scientific field with 8+ years of experience of related experience or a Master’s 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.
- Process Engineer:
- Bachelors degree in a related scientific field with 5+ years of experience of related experience or a Master’s degree with 3+ years of experience.
- 3+ years of experience in Manufacturing or Development roles with more than 1+ years in a drug product development and manufacturing function at a biotechnology or pharmaceutical company.
- Cell culture, cell therapy or aseptic processing experience in a cleanroom (plasmid and cell therapy experience highly preferred).
- High level of understanding to resolve complex issues relating to closed and sterile operations, operations with Biosafety level 2 or greater production materials, controlled operations, and compliance.
- Excellent communications and written skills with direct experience supporting significant strategy development & implementation.
- Ability to engage senior leaders within the organization and our clients.
- Demonstrated experience in leading meetings, teams, CMOs, including employee development.
- Experience with issues related to manufacturing is required.
- Knowledge and thorough understanding of current requirements for GLP, cGMP, and GCP is required.
- Direct experience with regulatory submissions is preferred.
- Forward-thinking and creative with high ethical standards.
- Team player with the ability to influence others to achieve successful regulatory.
- 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.
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 (did we mention we have an onsite gym with state-of-the-art equipment and ping pong table?), 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 a FLEXIBLE 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!!!