Sr./Process Engineer, Process Development and Tech Transfer (PVU)
Moderna is seeking an experienced process scientist/engineer to join the Moderna Personalized Vaccines Unit (PVU) for a position based at their Cambridge, MA site. The incumbent will work closely with PVU management, focused on process characterization, tech transfer, and manufacturing science activities in support of the manufacturing of Moderna's innovative personalized cancer vaccines at our manufacturing partners. He/she will work within the PVU Process and Analytical development teams, GMP Operations and Quality Assurance groups, as well as the GMP operations and Quality assurance functions of our external manufacturing partners. The successful candidate must be able to work in a dynamic environment, will have strong technical skills in a related field, and will have strong written and verbal communication skills. May require some travel during the process technical transfer as well as during the initial phase of GMP manufacturing campaigns.
- Takes a lead role in establishing a new advanced manufacturing capability for personalized vaccines at Moderna's internal and external manufacturing sites, supporting the receiving site as a member of the joint process transfer team during technology transfer, and then as Moderna's technical operations function during the manufacturing campaign. Collaborates closely with the Process Development team as needed.
- Contributes to process definition, facility fit, and development of Batch Production Records.
- Collaborates with the Automation Engineering function on concept development and detailed design of process specific custom cGMP manufacturing equipment. Supports equipment through the CQV lifecycle as needed.
- Collaborate on development of single use assemblies, and characterization of E&L profiles for product contact components.
- Support investigational activities in support of GMP operations, including review of investigational reports. Contribute to change control and process improvement initiatives as needed.
- Contribute to establishing process monitoring program as needed, and review process trends to ensure process control.
- May provide supervision to junior staff contributing to technical operations and planning functions in support of PVU external manufacturing activities.
- Bachelors +7 years, Masters + 5 years, or PhD + 3 years relevant experience in research, development, or manufacturing of biologics
- Knowledgeable of bioprocess purification unit operations as applied to protein, viruses, DNA, RNA, or similar biomolecules.
- Proven ability to work on multi-disciplinary development, tech ops/MS&T, or mfg teams.
- Demonstrated ability to manage own time, and deliver to program timelines.
- Familiar with cGMPs as applied to large biomolecule production and purification.
- Exceptional written and oral communication skills
- Preferred: Prior experience with technical transfer (sending or receiving) to a GMP bio-manufacturing facility.
- Preferred: Significant expertise with laboratory scale chromatography and tangential flow filtration unit operations.
- Preferred: Experience supporting deviation management, process change control, and process improvement
- Preferred: A proven track record of success in positions of increasing responsibility.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.